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JOURNEY II – TOTAL KNEE REPLACEMENT

Over the years, we have received feedback from our patients about how Movement Orthopedics has helped them. We are proud to share some of these patient testimonials below.

The JOURNEY II BCS Knee

Recent advances in biomedical engineering software have opened a new chapter on high performance knee implants.

One remarkable breakthrough has been the creation of the JOURNEY II BCS knee, a second-generation knee replacement that combines the stability and natural motion of the human knee with new low-friction materials that may extend the life of the implant.

While the lifespan of a knee implant is heavily influenced by the materials used to make it, the natural feeling of the implant during physical activity is dependent upon the way the patient’s muscles, ligaments and tendons are addressed during surgery and by the implant’s shape within the body after surgery.

As discussed previously in this booklet, the knee is a hinge joint, but it does not swing like a simple door hinge. It has a complex rotational motion that you don’t notice is there – but many patients know when it’s not there after total knee replacement. Traditional implants attempt to recreate this subtle swing-and-rotate action with either a rotating platform (a simple pivot point) within the implant or by requiring an angled alignment of the implant during surgery.

With these traditional knee replacement designs, the muscles and ligaments around your new joint have to work harder because the implant’s slightly unnatural shapes and resulting motion make these soft tissues move in unfamiliar, stressful ways. This leads to joint pain, muscle fatigue and the unnatural feeling patients experience while walking or bending in the months after their procedure.

The JOURNEY II BCS knee, on the other hand, is designed to reproduce the original internal shapes and angled forces of the human knee through its full range of motion – accommodating the swing-and-rotate of the joint with the same engineering principles your real knee currently uses. Because of this, your soft tissues don’t have to readjust to new shapes and forces after surgery and your stride can return to its natural rhythm.

The JOURNEY II BCS knee also reproduces the stability provided by your anterior cruciate ligament (ACL) and your posterior cruciate ligament (PCL). Your ACL and PCL are key to the stability of your real joint and contribute to natural motion when your knee is fully extended and fully bent. No other knee implant reproduces both functions.

Implant Components

In the knee replacement procedure, each prosthesis is made up of four parts.

The tibial component has two elements – a metal base and a plastic insert – and replaces and the top of the tibia (shin bone). This prosthesis is made up of a metal tray attached directly to the bone and a high-density plastic spacer that provides the bearing surface.

The femoral component replaces the bottom of the thigh bone or femur. This component also replaces the groove where the patella or kneecap rides.

The patellar component replaces the surface of the knee cap, which rubs against the femur. The patella protects the joint, and the resurfaced patellar button will slide smoothly on the front of the joint. In some cases, surgeons do not resurface the patella.

Bearing Surfaces

One of the keys to a successful implant is its ability to withstand the rigors of daily activity, and central to that is the quality of the artificial surfaces that slide against each other, or articulate, in the new joint.

In knee implants, bearing surface options have been somewhat limited over the last few decades. The standard substance used for the femoral component is cobalt chrome, a metal alloy typified by its toughness and biocompatibility. However,even this high-quality industry standard has its shortcomings. Over time, this metal surface can become roughened by bone and bone cement particles trapped between the femoral component and the plastic tibial insert.

This roughened surface, when rubbing against the plastic component up to two million times per year, can more quickly wear out your implant. When that happens, you will have to undergo surgery to replace the plastic piece, the femoral component, and possibly even the tibial component. For this reason, implants have been shown to last between ten and fifteen years in the human body.

An exciting material to enter orthopaedics in recent years is OXINIUM ◊ Oxidized Zirconium. This remarkable material combines the strengths of ceramic and metal, such as wear-reduction and strength, but does not have the weaknesses, such as limited implant options and the possibility of fracture.

Zirconium is a biocompatible metal, similar to titanium. When the zirconium alloy undergoes a unique heating process, the surface of the metal transforms into a ceramic. Even though the new ceramic surface is 4,900 times more abrasion resistant than cobalt chrome, it retains the toughness and flexibility of the underlying metal.

Because it can achieve this remarkable reduction in implant wear without sacrificing strength as actual ceramic components do, oxidized zirconium implants have the potential to last significantly longer.

The Procedure

Knee replacement surgery typically takes between one and two hours to complete. This section will provide you with a brief, easy-to-understand description of the surgical procedure. (Please consult with your physician for details regarding your specific procedure.)

An incision is made extending from the thigh, past the inside edge of the kneecap, and down to the shinbone.
The end of the femur is shaped in preparation for sizing the femoral trial component.
The top of the tibia is shaped for proper sizing of the tibial trial component.
The trial units are put in place and the appropriate implant size is selected.
The knee is assessed for alignment, stability, and range of motion.
The underside of the kneecap is prepared and patella trial is selected.
The trial units are removed and the final femoral, tibial, and patella components are implanted.
The incision is closed, a drain is put in, and the post-operative bandaging is applied.

Bone Cuts

Implant Components

Implanted

All information provided on this website is for information purposes only. Every patient’s case is unique and each patient should follow his or her doctor’s specific instructions. Please discuss nutrition, medication and treatment options with your doctor to make sure you are getting the proper care for your particular situation. If you are seeking this information in an emergency situation, please call 911 and seek emergency help.

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The Journey II Total Knee System: A Step Ahead – An Evolutionary New Design

Richard “alex” sweet ii, md, kate s. hamilton, pa-c, richard a. sweet, m.d. (retired 2022).

HOW THE NORMAL KNEE WORKS: It is a common misconception that the human knee functions as a simple hinge joint, with straight up and down flexion and extension. In reality the motion of the knee is much more complex, with six degrees of motion (not just the two of a hinge). As the knee bends and straightens, it also rotates internally and externally and slides front to back. Traditional total knee replacement designs have never been able to recreate the complex movement necessary for the knee to feel and function normally, especially in the high demand situations of a physical job or performing athletics.

The Journey II Total Knee Medial Pivot Design The “ Normal Feeling ” Knee Replacement

The Journey II Knee is a revolutionary new knee replacement design. It incorporates several new design changes, the most significant of which is Medial Pivot design. These design changes include:

MEDIAL PIVOT DESIGN: A revolutionary new concept. It is the first true major design advancement in knee replacement surgery in decades. The Medial Pivot Design is the first TKR design to incorporate all 6 degrees of motion of the natural knee. It does so by creating a “cupped” almost ball-in-socket articulation between the plastic and the femur on the medial side of the joint (blue arrow) and a flat articulation between the plastic and the femur on the lateral side joint (red arrow). The resultant kinematics (mechanics) are such that the “ball in socket” articula-tion on the inside of the joint keeps the femur centered in one spot as the knee bends, while the “flat” articulation on the outside of the knee allows lateral femur to glide backwards and rotate like the normal knee. The result: normal kinematics are restored in the Medial Pivot Design TKR.

GREATER STABILITY: An added inherent benefit of the medial ball-in-socket “cupping” of the Medial Pivot design is that it improves front-to-back knee stability vs that of the conventional TKR. Given that the ACL is sacrificed in all TKR surgery, the added front-to-back stability of the Medial Pivot design is a crucial improvement.

NORMAL ANATOMY RESTORED: The Journey II re-establishes the subtleties of normal joint line anatomy (which are altered by the arthritis process and not corrected by conventional TKR surgery.

IMPROVED QUADRICEPS STRENGTH: The Journey II, as opposed to other TKR designs, moves the contact point between the femur and the tibia forward to its normal position (blue arrow right as compared to orange arrow of traditional TKA designs). Reestablishing this forward contact point results in increased quadriceps strength (like being on the long end of a teeter-totter) GREATER RANGE OF MOTION: The Journey II design changes the anatomy of the back of the femoral component to mimic that of the normal knee (blue arrow left). The result is to provide for an extra 15 degrees of flexion versus what is expected in a conventional TKR. The cumulative result of these design changes of the Journey II TKR is that patients experience a knee replacement with improved kinematics, speedier recovery, better ultimate range of motion, enhanced stability, and ultimate functional ability for high demand situations at full recovery.

Design Limitations of Past Conventional TKRs Conventional knee replacements work well at what they are designed to do: rid the patient of arthritis and provide a new artificial knee that will function adequately. As TKR surgery has expanded into younger more active age groups who place a higher demand on their new knee, the goal of only eliminating arthritic pain is no longer sufficient. Design limitations of the conventional knee replacement that can inhibit the return to normal functioning and can lead to patient dissatisfaction include: 1. ABNORMAL KINEMATICS: The knee is NOT a hinge. A conventional knee replacement forces the knee to flex and extend like a hinge on a door, with a straight simple up and down motion. The normal knee, however, does not function like a hinge. Instead, as it bends and straightens, there is flowing rotation and front to back sliding to its kinematics. Only the Journey II TKA recreates these kinematic movements. 2. ALTERED ANATOMY: With conventional knee replacement surgery, anatomy of the knee is altered in several ways. When looking at a normal knee from the front, the joint line is not perpendicular to the tibia as it is with conventional TKR surgery, but instead is at a slight angle with the inside of the joint being slightly lower than the outside. To compensate, the femur must be correspondingly rotated to keep the ligaments balanced. This can lead to abnormal forces on the knee, creating sensations of instability, dissatisfaction, and potential early failure of the knee replacement. 3. DIMINISHED QUADRICEPS STRENGTH: In conventional TKR surgery the contact point between the femur and tibia is shifted towards the back of the knee. This shift causes abnormal (called “paradoxical”) motion to occur when the knee starts to bend. The mechanical effect is that the strength of the quadriceps muscle is weakened. This is of clinical importance as a patient with a conventional TKR attempts to squat, climb steps, or perform other high demand activities.

Results of Conventional TKR Surgery Design Limitations: The result of the limitations noted above is that the ligaments and capsule of the knee see an altered knee anatomy, altered knee kinematics, and a weakened quadriceps muscle. This can cause a range of problems from:

A patient perceiving a subtle sensation that the knee does not “feel normal”
More significant problems such as less range of motion, reduced stability, a weak knee/quadriceps complex, intermittent soreness/swelling, problems with stair climbing, and difficulties engaging in recreational activities and vigorous work.

Conclusion The Journey II TKA is truly a revolutionary step forward in the design of total knee implants. With proper surgical technique and in the hands of a well-trained surgeon, the Journey II knee can produce results superior to the traditional total knee design. It is our goal as your surgical team to continue to improve our surgical techniques and to look for new advances in technology that allow us to give you the best result possible.

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1425 State St., ,New Albany 47150 (812) 920-0408

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The JOURNEY II BCS Knee

Recent advances in biomedical engineering software have opened a new chapter on high performance knee implants.

While the lifespan of a knee implant is heavily influenced by the materials used to make it, the natural feeling of the implant during physical activity is dependent upon the way the patient's muscles, ligaments and tendons are addressed during surgery and by the implant's shape within the body after surgery.

As discussed previously in this booklet, the knee is a hinge joint, but it does not swing like a simple door hinge. It has a complex rotational motion that you don't notice is there - but many patients know when it's not there after total knee replacement. Traditional implants attempt to recreate this subtle swing-and-rotate action with either a rotating platform (a simple pivot point) within the implant or by requiring an angled alignment of the implant during surgery.

With these traditional knee replacement designs, the muscles and ligaments around your new joint have to work harder because the implant's slightly unnatural shapes and resulting motion make these soft tissues move in unfamiliar, stressful ways. This leads to joint pain, muscle fatigue and the unnatural feeling patients experience while walking or bending in the months after their procedure.

The JOURNEY II BCS knee, on the other hand, is designed to reproduce the original internal shapes and angled forces of the human knee through its full range of motion - accommodating the swing-and-rotate of the joint with the same engineering principles your real knee currently uses. Because of this, your soft tissues don't have to readjust to new shapes and forces after surgery and your stride can return to its natural rhythm.

Implant Components

In the knee replacement procedure, each prosthesis is made up of four parts.

The tibial component has two elements - a metal base and a plastic insert - and replaces and the top of the tibia (shin bone). This prosthesis is made up of a metal tray attached directly to the bone and a high-density plastic spacer that provides the bearing surface.

The femoral component replaces the bottom of the thigh bone or femur. This component also replaces the groove where the patella or kneecap rides.

Bearing Surfaces

The Procedure

An incision is made extending from the thigh, past the inside edge of the kneecap, and down to the shinbone.

The end of the femur is shaped in preparation for sizing the femoral trial component.

The top of the tibia is shaped for proper sizing of the tibial trial component.

The trial units are put in place and the appropriate implant size is selected.

The knee is assessed for alignment, stability, and range of motion.

The underside of the kneecap is prepared and patella trial is selected.

The trial units are removed and the final femoral, tibial, and patella components are implanted.

The incision is closed, a drain is put in, and the post-operative bandaging is applied.

All information provided on this website is for information purposes only. Every patient's case is unique and each patient should follow his or her doctor's specific instructions. Please discuss nutrition, medication and treatment options with your doctor to make sure you are getting the proper care for your particular situation. If you are seeking this information in an emergency situation, please call 911 and seek emergency help.

JOURNEY ◊ II Active Knee Solutions

Aren't all total knee implants the same?

In theory, yes, all total knee implants are intended for the same purpose: the elimination of painful bone-on-bone contact, and the restoration of motion and function to the joint. In reality, however, the way each implant is designed, built and implanted not only makes them different, but can have an impact on how well they perform for each patient.

How your knees move

Commonly described as a hinge joint, your knees actually do much more than simply swing back and forth. In fact, every time your knee bends, forces in and around the joint work together to produce a subtle and complex rotational movement that you don't even realize is there. However, if this rotational movement is removed, the change can be felt in the muscles and ligaments through the entire leg.

The JOURNEY ◊ II AKS difference

One of the most remarkable breakthroughs in design of total knee replacements has been the creation of the JOURNEY II Active Knee Solutions. Designed using the latest in human simulation software, and built using some of the most wear-resistant materials available, this unique implant was designed to address two of the most common concerns associated with knee replacement implants: implant wear and implant feel.

The information listed on this site is for informational and educational purposes and is not meant as medical advice. Every patient's case is unique and each patient should follow his or her doctor's specific instructions. Please discuss nutrition, medication and treatment options with your doctor to make sure you are getting the proper care for your particular situation.

JOURNEY ◊ II AKS PHYSIOLOGICAL MATCHING ◊

The rationale behind the concept of PHYSIOLOGICAL MATCHING ◊ is simple: any change you make to the knee joint will ultimately impact the entire leg. Of course, as is so often the case, simple rarely means easy.

The primary hurdle to overcome in a knee replacement is the knee itself. Described as a hinge joint, the knee actually does much more than bend back and forth. In fact, every time your knee bends, forces in and around the knee cause it to move with a complex rotational motion that most of us never realize. However, when that motion is removed after knee replacement, the result can be disappointing.

Traditionally, most knee implants have attempted to replace the natural swing-and-rotate of the knee by building a simple pivot point into the implant (known as a rotating platform) or by using a slightly angled alignment of the implant during surgery. Unfortunately, both of these options can force the muscles and ligaments around the new joint to work harder and move in unfamiliar, stressful ways; resulting in pain, muscle fatigue and an unnatural feeling while walking or bending the knee.

The JOURNEY ◊ II implant was designed using Smith & Nephew's proprietary LifeMOD ◊ human simulation software. This advanced software system allows engineers to examine in a virtual 3-D environment the exact internal shapes and angled forces that act on the knee throughout each phase of motion. As a result, the JOURNEY II implant has been designed to physiologically match how the hard structures of a normal knee joint move and rotate in an effort to maintain normal muscle activity and return the patient's stride to it's a natural rhythm.

Important safety note

Individual results of joint replacement vary. Implants are intended to relieve knee pain and improve function, but may not produce the same feel or function as your original knee. There are potential risks with knee replacement surgery such as loosening, wear and infection that may result in the need for additional surgery. Patients should not perform high impact activities such as running and jumping unless their surgeon tells them that the bone has healed and these activities are acceptable. Early device failure, breakage or loosening may occur if a surgeon's limitations on activity level are not followed.

Talk to your doctor to determine what treatment may be best for you.

JOURNEY ◊ II AKS implant feel

The right "feel" often starts with the right design.

To most of us, total knee implants all look very similar. With the exception of color (the OXINIUM ◊ alloy used in JOURNEY ◊ II implants is black while the cobalt chrome used in other implants is silver), it can take an experienced eye to see the subtle differences in size and shape between two implants. However, as subtle as the differences may seem, they can often have a profound impact on how an implant feels to the patients after surgery.

Fortunately, JOURNEY II implants were designed using a concept called PHYSIOLOGICAL MATCHING ◊ . This unique process begins with proprietary human simulation software that virtually recreates the exact internal shapes and angled forces that act on the knee through each phase of motion. This detailed information helped Smith & Nephew engineers create an implant that replicates as closely as possible the complex, natural rotation of the knee.

JOURNEY ◊ II AKS Implant Wear

Implant materials can impact durability.

Virtually all total knee replacement systems use a combination of metal and plastic components to replace the surfaces of a damaged knee. Metal is typically used to replace the surfaces of the bone, while plastic is most commonly used to replace the joint's cartilage.

Unfortunately, the metal and plastic surfaces of an implant can wear down over time. The primary cause of this "implant wear" is the friction created when the upper, metal, part of an implant - called the femoral component - rubs against the plastic insert. Even with pristine implants, over time, this friction can cause tiny particles of the insert to wear away. If the metal component becomes scratched for any reason, this destructive process can be increased dramatically. In fact, this type of implant wear is a leading cause of premature knee replacement failure.

Fortunately, implant wear can be offset by using advanced, wear-reducing materials during the creation of the implant.

VERILAST ◊ Technology

Unlike other implants that only available with cobalt chrome for their metal femoral components, the JOURNEY II Active Knee implant can also be made with a proprietary metal alloy called OXINIUM ◊ Oxidized Zirconium. While cobalt chrome has been used successfully for years, laboratory tests have shown that the "ceramicized" OXINIUM metal alloy is twice as hard as cobalt chrome and can be twice as resistant to the type of scratching that can cause implant wear. 1 First introduced in 1997, OXINIUM implants have been used in more than 1 million surgeries around the world.

And since each implant is a combination of metal and plastic, JOURNEY II implants also use a harder, highly cross-linked polyethylene known as XLPE for the plastic insert.

Working together, these materials form a bearing surface combination known as VERILAST Technology, which is unique to global medical device maker, Smith & Nephew.

Important testing note

VERILAST Technology has been designed to address "wear and tear," which is only one reason why a knee implant may need to be replaced. Listen carefully when your orthopedic surgeon reviews other risks that can shorten the life of your new knee - such as infection, excessive weight gain or high impact sports.

The results of laboratory wear simulation testing have not been proven to predict actual joint durability and performance in people. A reduction in wear alone may not result in improved joint durability and performance because other factors can affect joint durability and performance and cause medical conditions that may result in the need for additional surgery. These other factors were not studied as part of the testing.

Important safety notes

Journey ◊ ii xr, rediscover your active life with the high performance, a new chapter in knee implants.

Recent advances in biomedical engineering software have opened a new chapter in high performance knee implants.

One remarkable breakthrough has been the creation of the JOURNEY ◊ II XR Active Knee System, which combines an implant designed to restore the stability and natural motion of the human knee with low-friction materials that may help extend the longevity of the implant itself.

While the longevity of a knee implant is heavily influenced by the materials used to make it, the natural feeling of the implant during physical activity is dependent upon the way the patient's muscles, ligaments and tendons are addressed during surgery and by the implant's shape within the body after surgery.

Every knee implant design is faced with two important challenges; how to recreate the normal swing-and-rotate motion of your natural knee, and how to restore stability to your joint after surgery.

For the first challenge, conventional knee implant designs have attempted to recreate the natural, fluid motion of the knee with either a rotating platform (a simple pivot point) within the implant or by requiring an angled alignment of the implant during surgery. Both of these options force the muscles around your knew joint to work harder as they adjust to the joint's new and unnatural shapes and movement patterns.

For the second challenge, most implants rely on design aspects within the plastic insert to provide the stability that is sacrificed after the anterior and posterior cruciate ligaments (ACL/PCL) within your joint are removed to accommodate the new implant.

JOURNEY II XR is Different

Fortunately, the JOURNEY II XR Knee Implant is different from most knee implants.

First, the JOURNEY II XR implant features an anatomically shaped femoral component and two plastic inserts designed to work together to reproduce the original internal shapes and forces of your natural knee as it goes through its full range of motion. This attention to anatomic detail means that the muscles and other soft tissues around your joint don't have to adjust to unfamiliar stresses and you may be able to return to a natural pattern of motion after surgery.

Second, the JOURNEY II XR uses a U-shaped tibial base plate that fits around your healthy ACL and PCL, allowing them to remain in place and function normally after surgery. In short, the function of these important ligaments doesn't have to be re-engineered because they were never removed.

Added Durability

The JOURNEY II XR implant addresses durability with VERILAST ◊ Technology, a combination of two wear reducing materials - the proprietary OXINIUM ◊ metal alloy and a highly cross-linked plastic insert - that were designed to address wear on both surfaces of the implant.

Because it is twice as hard as cobalt chrome, the most commonly used metal in knee implants, implants made with OXINIUM material have been shown in lab testing to reduce joint wear by more than 80% when compared to cobalt chromium components. 1

VERILAST Technology was designed to address "wear and tear," which is only one of several reasons why a knee implant may need to be replaced. Each patient should listen carefully when his or her orthopedic surgeon reviews other risks that can shorten the life of a new knee - such as infection, weight gain or high impact sports.

Not all patients are candidates for the JOURNEY II XR Knee Implant. Discuss your condition and implant options with your surgeon.

jHunter, G., and Long, M., Abrasive Wear of Oxidized Zr-2.5Nb, CoCrMo, and Ti-6Al-4V Against Bone Cement. 6th World Biomaterials, Minneapolis, MN 2000, p. 835

Knee Replacement VERILAST Knee JOURNEY◊ II VISIONAIRE◊ Patient Matched Technology Partial Knee Replacement JOURNEY◊ II UNI Partial Knee Replacement ZUK◊

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JOURNEY ◊ II AKS implant wear

How long do you want your knee implant to last.

In rigorous lab testing, Smith & Nephew's LEGION ◊ CR Knee made with the combination of our OXINIUM Technology and XLPE was subjected to 45 million cycles, or simulated steps. That's equal to around 30 years of physical activity. 2
The data showed that after 5 million cycles, the LEGION CR Knee made with the combination of our OXINIUM Technology and XLPE showed 98% less wear than did the same knee made using traditional implant materials. And when LEGION CR knee with the combination of our OXINIUM Technology and XLPE kept "walking" out to 45 million cycles, it was again compared to the traditional knee's 5 million cycle data. Even with 40 million more cycles, the LEGION knee with the combination of our OXINIUM Technology and XLPE showed 81% less wear. 2-8

Important safety notes

Elena Losina, Ph.D., co-director, Orthopaedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital, Boston; William J. Robb III, M.D., chairman, Department of Orthopaedic Surgery, NorthShore University Health System, Evanston, Ill; Feb. 10, 2012, presentation, American Academy of Orthopaedic Surgeons, annual meeting, San Francisco.
Testing concluded at 45 million cycles. ISO 14243-3 defines test completion at 5 million cycles.
Goldsmith AA et al., "Comparative study of the activity of the total hip arthroplasty patients and normal subjects". J Arthrop, (16)5:613-619, 2001.
Morbidity and mortality weekly report, 55(40):1089-1092, October 13, 2006.(//www.cdc.gov/mmwr/preview/mmwrhtml/mm5540a2.htm?s_cid=mm5540a2_e. Accessed on October 30, 2009).
Gioe TJ et al., "Knee Arthroplasty in the young patient - Survival in a community registry". Clin Orthop Relat Res, 464:83-87, 2007.
Wallbridge N and Dowson D. "The walking activity of patients with artificial hip joints". Eng Med 11:95, 1982
Wimmer M A et al., "Joint motion and daily activity profile of total knee patients in comparison with the ISO knee wear simulator". Paper 0159, 48th ORS, 2002.
Huddleston J I et al., "How often do patients with high-flex total knee arthroplasty use high flexion?",Clin Orthop Relat Res, 467:1898-1906, 2009.
Naal F D et al., "How active are patients undergoing total joint arthroplasty? A systematic review", Clin Orthop Relat Res, DOI 10.1007/s11999-009-1135-9, published online: 28 October 2009.
R. Papannagari, G. Hines, J. Sprague and M. Morrison, "Long-term wear performance of an advanced bearing knee technology," ISTA, Dubai, UAE, Oct 6-9, 2010.

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News & Events

New journey xr ii total knee replacement implant.

Bozeman, MT – Bridger Orthopedic has announced the addition of the highly anticipated, JOURNEY™ II XR Total Knee implant to its orthopedic offerings that use the CT-free, NAVIO™ Surgical System.

Unlike traditional total knee implants, the JOURNEY II XR Total Knee Implant uses a specially designed U-shaped tibial base plate that allows a patient’s healthy anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) to remain in place after surgery. These ligaments help provide natural stability and support to your knee and are often removed to accommodate the base plates used in other total knee implants. The JOURNEY II XR implant also features an anatomically shaped femoral component and two plastic inserts, designed to work together to reproduce the original internal shapes and forces of the natural knee as it goes through its full range of motion. Lastly, this advanced implant also features the proprietary VERILAST™ Technology, a unique combination of materials designed to reduce implant wear.

Along with the advances offered by the implant itself, Dr. Martin Gelbke at Bridger Orthopedic will perform the JOURNEY II XR surgery using the NAVIO Surgical System.

Using the NAVIO surgical system, the surgeon collects and registers patient-specific anatomic data which the system uses to create a real-time, digital, 3D model of the patient’s knee. This layer of planning is designed to enable accurate implant placement and ligament balancing to achieve optimal patient outcomes. The NAVIO system does not require a pre-operative CT-scan, meaning patients are not exposed to the potentially harmful radiation experienced with this type of imaging.

NOTE: Not all patients are candidates for the JOURNEY II XR implant. The JOURNEY II XR implant is indicated for use in total knee replacement patients where the cruciate ligaments and the collateral ligaments remain intact.

Discuss your condition and implant options with your surgeon. Individual results of joint replacement vary. Implants may not produce the same feel or function as your original knee. There are potential risks with knee replacement surgery such as loosening, fracture, dislocation, wear and infection that may result in the need for additional surgery.

NAVIO is not for everyone. Children, pregnant women, patients who have mental or neuromuscular disorders that do not allow control of the knee joint, and morbidly obese patients should not undergo a NAVIO procedure.

This information is for informational and educational purposes and is not meant as medical advice. Consult your physician for details to determine if NAVIO or JOURNEY II XR is right for you.

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.8 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN). For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

™ is a Trademark of Smith & Nephew

ORTHOPAEDICS

Journey ii ◊ rox ◊ total knee solution with conceloc ◊ and oxinium ◊ technologies.

Combining cemented and cementless technologies for a reverse hybrid approach, we bring to the stage our latest and greatest in joint reconstruction

Remix your reconstruction

Surgeons continue to pursue solutions in TKA to both improve patient satisfaction - by making the knee feel more normal - and reduce some of the most common failure modes such as tibial aseptic loosening, instability and infection. 1,2 However, current implant designs have not addressed both objectives and literature still cites that up to 20% of patients are not satisfied. 3-5

We mix things up on our approach to TKA, combining the anatomic design and normal kinematics 6-10 of JOURNEY II TKA with the cutting-edge technology of CONCELOC Advanced Porous Titanium and the unrivalled material science 11-17 of OXINIUM Oxidized Zirconium, to build the foundation for outcomes you ’ ll want on repeat.

We call it our greatest hits. You’ll call it a best -in-class knee construct.

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* Compared to non-JOURNEY II knees

We thank the patients and staff of all the hospitals in England, Wales and Northern Ireland who have contributed data to the National Joint Registry. We are grateful to the Healthcare Quality Improvement Partnership (HQIP), the NJR Steering Committee and staff at the NJR Centre for facilitating this work.

The views expressed represent those of Smith+Nephew and do not necessarily reflect those of the National Joint Registry Steering Committee or the Health Quality Improvement Partnership (HQIP) who do not vouch for how the information is presented.

The data used for this analysis was obtained from the National Joint Registry (“NJR”), part of the Healthcare Quality Improvement Partnership (“HQIP”).

HQIP, the NJR and/or its contractor, Northgate Public Servi ces (UK) Limited (“NPS”) take no responsibility (except as prohibited by law) for the accuracy, currency, reliability and correctness of any data used or referred to in this report, nor for the accuracy, currency, reliability and correctness of links or references to other information sources and disclaims all warranties in relation to such data, links and references to the maximum extent permitted by legislation including any duty of care to third party readers of the data analysis.

For detailed product information, including indications for use, contraindications, precautions and warnings, please consult the product’s applicable Instructions for Use (IFU) prior to use.

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JOURNEY II BCS Knee System Demonstrates Improved Patient Outcomes, Lower Healthcare Costs

Reduced cost is equivalent to approximately 10 percent in savings to the overall procedure price.

Fifty-one percent less likely to be readmitted to the hospital within 30 days;
Thirty-five percent more likely to be discharged to their home; and
Forty-one percent less likely to be discharged to a skilled nursing facility for further care.
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http://orcid.org/0000-0002-2051-8451 Iain McNamara 1 , 2 ,
Valerie Pomeroy 2 ,
Allan B Clark 3 ,
Graham Creelman 4 ,
Celia Whitehouse 1 ,
J Wells 2 ,
B Harry 5 ,
Toby O Smith 6 ,
Juliet High 7 ,
Ann Marie Swart 2 , 8 ,
Celia Clarke 2
1 Norfolk and Norwich University Hospital , Norwich , UK
2 University of East Anglia , Norwich , UK
3 Norwich Medical School , University of East Anglia , Norwich , UK
4 Mental Health Act Review Panels , Norfolk and Suffolk , UK
5 Department of clinical neurosciences , University of Cambridge , Cambridge , UK
6 Faculty of Medicine and Health Sciences , University of East Anglia , Norwich , UK
7 Norwich Clinical Trials Unit , Norwich , UK
8 Health Sciences , University of East Anglia , Norwich , UK
Correspondence to Professor Iain McNamara; iain.mcnamara{at}nnuh.nhs.uk

Objectives To determine if a newer design of total knee replacement (TKR) (Journey II BCS) produces superior patient-reported outcomes scores and biomechanical outcomes than the older, more established design (Genesis II).

Setting Patients were recruited from an NHS University Hospital between July 2018 and October 2019 with surgery at two sites. Biomechanical and functional capacity measurements were at a University Movement and Exercise Laboratory.

Participants 80 participants undergoing single-stage TKR.

Interventions Patients were randomised to receive either the Journey II BCS (JII-BCS) or Genesis II TKR.

Primary and secondary outcome measures Primary outcome was the Oxford Knee Score (OKS), at 6 months. Secondary outcomes were: OKS Activity and Participation Questionnaire, EQ-5D-5L and UCLA Activity scores, Timed Up and Go Test, 6 min walk test, lower limb kinematics and lower limb muscle activity during walking and balance.

Results This study found no difference in the OKS between groups. The OKS scores for the JII-BCS and Genesis II groups were mean (SD) 42.97 (5.21) and 43.13 (5.20) respectively, adjusted effect size 0.35 (-2.01,2.71) p=0.771

In secondary outcome measures, the Genesis II group demonstrated a significantly greater walking range-of-movement (50.62 (7.33) vs 46.07 (7.71) degrees, adjusted effect size, 3.14 (0.61,5.68) p=0.02) and higher peak knee flexion angular velocity during walking (mean (SD) 307.69 (38.96) vs 330.38 (41.40) degrees/second, adjusted effect size was 21.75 (4.54,38.96), p=0.01) and better postural control (smaller resultant centre of path length) during quiet standing than the JII-BCS group (mean (SD) 158.14 (65.40) vs 235.48 (176.94) mm, adjusted effect size, 59.91 (–105.98, –13.85) p=0.01.).

Conclusions In this study population, the findings do not support the hypothesis that the Journey II BCS produces a better outcome than the Genesis II for the primary outcome of the OKS at 6 months after surgery.

Trial registration number ISRCTN32315753 .

HEALTH ECONOMICS
Clinical trials
ORTHOPAEDIC & TRAUMA SURGERY
REHABILITATION MEDICINE

Data availability statement

Data are available on reasonable request. Reasonable requests for data will be considered by the trial team.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/bmjopen-2022-061648

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STRENGTHS AND LIMITATIONS OF THIS STUDY

This is a two arm, superiority, observer-blind, participant-blind and clinical staff-blind, randomised control trial.

It uses a wide variety of patient reported outcomes measures and biomechanical measurements to determine if one implant is superior to the other

The required sample size was achieved with only one person lost to follow-up.

A potential limitation is the relatively large number of secondary outcomes.

The surgeons all had a much greater familiarity with the implantations of Genesis II implants.

Original protocol for the study is mentioned here: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4143-4 .

Introduction

Despite total knee replacement (TKR) being a recommended surgical treatment for end-stage knee osteoarthritis, 1 up to 34% of all patients following TKR have poor functional outcomes. 2–6 With estimates of osteoarthritis of the knee affecting one in eight people in the USA 7 and 250 million individuals worldwide 8 the number of patients with intrusive symptoms after surgery is significant.

Multiple changes in implant design have been introduced to try to improve patient outcomes and while some implant design alterations have led to improvements in patient-reported outcome measures (PROMS) 9–11 and kinematics 12 13 not all have led to differences. 14–20

The Genesis II (Smith & Nephew, Memphis, Tennessee, USA) TKR has been reported to have good survivorship and patient satisfaction 13 21 and is commonly used in the UK 22 An evolutionary design, the Journey II BCS (JII-BCS; Smith & Nephew), also manufactured by Smith and Nephew, has been developed to improve kinematic outcome compared with the Genesis II by using a bicruciate design. 23 This design change has been supported by encouraging fluoroscopic studies. However, to date, no randomised controlled trials (RCTs) have been conducted to assess if there is a difference in the outcome compared with its predicate design. 24

This trial aimed to assess whether the JII-BCS would produce better patient reported and movement outcomes than the Genesis II.

The published protocol included the aims for investigating: the rotational profile around the native knee and following TKR; and patients’ experiences and surgeons’ experiences. 25 These findings will be reported in subsequent manuscripts.

Trial design, randomisation, blinding to intervention allocation, ethics and registration

A two-arm, superiority RCT comparing the JII-BCS knee implant (experimental intervention) to the Genesis II knee implant (control intervention) was performed. The trial was observer-blind, participant-blind and clinical staff-blind. Only the operating surgeon and theatre team knew which implant was used for an individual participant.

Trial participants were assigned to either the JII-BCS or Genesis II group using a computer-generated, 1:1 randomisation schedule stratified by site and age (<60 years = younger; ≥60 years = older). 26 27 Group allocation was revealed using REDCap, 28 29 the interactive web-randomisation system, to a member of the research team who was not involved in either the clinical care or assessments of any participant. Allocation was concealed from the surgical team until after the preoperation baseline measures were completed.

Sample size

The sample size was calculated from the Oxford Knee Score (OKS, primary outcome measure). 30 The RCT was powered at 80% with a 5% significance level to detect a minimally important clinical difference of five points 31 32 with an SD of 7.4 points. 33 Accounting for an estimated attrition rate of 10% at 6 months postsurgery the estimated sample size was 80 participants (40 per group).

Participants, setting and recruitment

Full eligibility criteria are provided in the published protocol. 25 In brief, participants were aged at least 18 years and met the clinical and radiological criteria for a single-stage TKR. People were excluded if they: had a fixed-flexion deformity of at least 15° or non-correctable varus/valgus deformity of at least 15°; had inflammatory arthritis or previous septic arthritis; had previous surgery to the collateral ligaments of the affected knee; had a contralateral TKR implanted less than 1 year earlier; had severe comorbidity that could present an unacceptable safety risk or were pregnant; were a private patient; were likely to be living outside the clinical centre catchment area at 6 months postsurgery or were enrolled on another clinical trial.

Patients were recruited at a university teaching hospital with surgery conducted at two sites. Outpatient physiotherapy was conducted in a single hospital. The Movement and Exercise Laboratory at the associated University (MoveExLab) was the setting for measures of functional capacity and biomechanics.

Interventions

All participants received routine NHS care for people with TKR irrespective of the implant received. This included following a standard postoperative rehabilitation of outpatient physiotherapy centred on knee strength and range of motion (ROM) exercises within the first 6 weeks after surgery. Patients received the same physiotherapy protocols and classes.

Experimental intervention

Participants in the experimental group received the JII-BCS. The JII-BCS is a dual-cam post designed to substitute for both the anterior cruciate ligament and posterior cruciate ligament. In addition the femoral and tibial components are asymmetric and the polyethylene insert is a medially concave and laterally convex shape. The device is designed to provide guided motion, and thus improve knee kinematics, and increase anteroposterior stability throughout knee flexion.

.Control intervention

Participants in the control group received the Genesis II (Smith and Nephew), posterior stabilised (PS) TKR. The design features specific to the implant and a lateralised trochlear groove to improve patellar contact and tracking, an externally rotated femoral implant design and an anatomically shaped tibial baseplates.

Surgical techniques

All four surgeons had extensive experience, at least 5 years, of the Genesis II implant. All undertook cadaveric training on the JII-BCS and declared that they were competent in the surgical technique having completed their operative learning curve before starting the trial. Both implants are uncoated, cemented implants. The surgical procedure followed the standard manual surgical approach and technique through a medial parapatellar approach in all cases with intramedullary femoral and tibial rods to provide the alignment of the components. Patella resurfacing was used in both groups.

Data collection schedule

Data collection time points for the primary outcome measure were: at least 1 day before surgery (baseline), 7±2 days after surgery (1 week postoperatively), 6–8±2 weeks after surgery (2 months), 6 months±4 weeks after surgery (outcome, primary time point). Secondary outcomes were collected at baseline, 2 months and 6 months. Any differences from these time points are provided in the outcome measures section.

Outcome measures

Primary outcome measure.

The OKS was the primary outcome measure. This is a 12-question patient self-assessment of knee function and pain 30 with values ranging from 0 (worst outcome) to 48 (best outcome).

Secondary outcome measures

Patient-reported outcome questionnaires.

The Oxford Knee Score Activity and Participation Questionnaire (OKS-APQ), which complements the OKS by assessing everyday activity and social participation. 34 The overall score is from 12 to 60 with 12 being the best outcome.

The EQ-5D-5L is a self-report questionnaire consisting of five questions and a Visual Analogue Scale. Higher values indicate better quality of life. 35

The UCLA Activity score (UCLA) to assess physical activity self-rating scale ranged from 0 (complete inactivity) to 10 (participation in impact sport).

Walking and balance functional ability

Timed Up and Go Test (TUG)—seconds to rise from chair, walk 3 m and return to sitting; mean of three trials. 36 The reported minimal detectable change after TKR is 2.27 s. 37 A lower value indicates better function.

Six min walk test—metres walked in 6 min around a 20 m circuit. 38 39 The reported minimal detectable change from baseline after TKR is 26 metres. 40 A higher value indicates greater function.

Modified Star-Excursion Test 41 (cm/leg length) where larger values indicate better balance.

Movement performance during walking and balance

For these simultaneous measures, participants wore shorts and were bare-footed. Reflective sensors were placed in accordance with the Plug-In Gait model (Vicon) for the lower limb and three-dimensional motion data were collected, at 100 HZ, with eight wall-mounted infrared cameras (Vicon Motion System, Oxford, UK). Three embedded force plates (BERTEC, Ohio, USA) were used to collect kinetic data at 2000 Hz for walking tasks and 100 Hz for balance tasks. Surface electromyographic sensors (EMG: Delsys) were placed bilaterally on the Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Bicep Femoris and lateral head of the Gastrocnemius following SENIAM guidance. EMG data were collected at 2000 Hz.

For walking tasks, participants were asked to walk in a straight line along a 10 m walkway at their self-selected speed. For double stance balance activities, participants were instructed to stand with their feet shoulder-width apart. For single stance balance activities, participants were instructed to stand on one leg with hands-on-hips. Three trials of 10 s were recorded for each activity.

For the stair ambulation task, participants were asked to complete six ascents and six descents all unaided, leading with the operated limb for three trials and the non-operated limb for the remainder. The stairs had four steps. The first step was 16.5 cm, and the others were 15 cm high. Handrails were available if participants needed support.

Movement data were processed in accordance with the Vicon Plug-in Gait Model (Oxford Metrics, Oxford, UK). Raw EMG was filtered with pass bands at 10 and 500 Hz, rectified and low pass filtered using a fourth order Butterworth with a 10 Hz cut-off. Walking data were normalised to 101 data points for the gait cycle. Three trials of tasks were used to create a mean for each measure per participant. Values were extracted using a purpose-built MATLAB script. Data were processed by motion analysis experts in the research team.

Primary movement performance measures

The JII-BCS is expected to provide more normal kinematics during knee movement than Genesis II due to the design changes discussed earlier. Other authors have indicated that the femo-tibial relationship may be more normal during deep knee bend 42 and more stable during walking 43 Accordingly, people with the Journey prosthesis may 44 45 or may 43 have greater knee ROM, may walk faster, 46 47 and may have a longer stride length 46 47 than people receiving a comparison knee replacement. In addition, greater stability of the femur on the tibia could produce greater knee flexion angular velocity as dynamic knee loading could be more normal. However, there is only one non randomised study of 18 patients comparing the JII-BCS directly with the Genesis II. 45 Based on the available literature, the hypothesis driving the kinematic investigation was that people receiving the JII-BCS compared with those receiving the Genesis II would have greater walking velocity, step-length symmetry (resulting from longer stride length), knee ROM and peak knee flexion angular velocity.

Walking speed (metres/second). A higher value indicates better performance

Step length symmetry during walking. Step length ratio was calculated as ((2xOp)/Op+NOp))−1); where Op is the step length of the operated leg and NOp is the step length of the non-operated leg. Zero indicates perfect symmetry and best performance.

Knee ROM during walking (degrees). Higher values indicate better performance.

Peak knee flexion angular velocity during walking (degrees per second). This was inadvertently omitted from the statistical analysis plan (SAP). Higher value indicates better performance.

Secondary movement performance measures.

Double stance support (% of gait cycle). It was planned to measure cadence, (steps/min), step length (m) and stride length (m). However, there is redundancy with the temporal-spatial gait parameters of walking speed and step length symmetry which are included in the primary movement performance measures.

Peak extension and flexion moments of operated knee during the gait cycle (Nm/kg).

Hip and ankle ROM during walking.

Peak knee flexion angular velocity during stepping up onto a stair.

Percentage of gait cycle for peak activation of Vastus Medialis, Vastus Lateralis, Tibialis Anterior, Biceps Femoris and Lateral head of Gastrocnemius (% of gait cycle).

Balance measures were derived from kinetic data (from force plates) during standing still: single stance on the operated lower limb for 10 s with eyes open (yes/no) and duration maintained; resultant centre of pressure path length (COP cm) in double stance with eyes closed; and resultant COP velocity (cm/s) in double stance with eyes closed.

Clinical context and adverse events

Data on length of hospital stay and complications related to the surgery (eg, anaesthesia-related problems, bleeding, morbidities) were collected from a notes review. At each visit, participants were asked about their pain medication and if they had received additional treatment since their surgery/previous visit and what this entailed. Any need for revision surgery was recorded. All adverse events identified were tracked until resolution.

The SAP was finalised and agreed prior to database lock and analysis was completed blinded to group allocation ( online supplemental file ). For all outcomes the hypothesis tests and 95% CIs were two sided; and a p<0.05 was considered significant. An intention-to-treat analysis was conducted that is, all randomised participants regardless of their eligibility or adherence were analysed according to the treatment they were randomised to receive. The analysis was undertaken by the Trial Statistician using Stata V.16.

Supplemental material

For the primary outcome, the mean OKS at 6 months was compared between the control and experimental groups using a general linear model adjusting for site and age (<60 years/≥60 years). An adjusted analysis was conducted using the same model but adjusting for the OKS at baseline. The model assumptions were checked graphically, and sensitivity analysis done using a non-parametric bootstrap using 5000 repetitions.

All the other outcomes were analysed separately at 2 months and 6 months using the same general linear model specified above and a corresponding adjusted analysis. The exception was ability to balance for 10 s. This was analysed using a logistic regression model adjusting for site and age.

Patient and public involvement

A patient representative, who had previously undergone knee replacement surgery, was involved in the protocol development, assessment of the burden of the intervention and time taken to participate in the research and oversight of the trial as a member the trial management group. The representative also contributed to the planning and writing of research dissemination materials.

Participants were recruited between July 2018 and October 2019. Last follow-up visits were in October 2020 with some impact and delayed visits due to COVID-19.

In the published protocol, 25 the analysis plan included a per-protocol and safety analysis. This was not undertaken as the implants were used as intended so these populations would be the same as the intention-to-treat population.

Flow of participants through the trial

In total, 105 of 153 people screened were eligible to take part, 16 declined participation and eight were excluded for other reasons. Therefore, 81 of 153 people (53%) were recruited. All participants in the Genesis II group (n=40) received their allocated intervention. In the JII-BCS group (n=41), one participant withdrew prior to surgery (postrandomisation exclusion). Full details are in the Consolidated Standards of Reporting Trials (CONSORT) flow chart ( figure 1 ).

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Consolidated Standards of Reporting Trials (CONSORT) diagram.

Participant characteristics

There were no discernible baseline differences between the groups ( table 1 ).

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The baseline characteristics of participants

Primary outcome comparison: 6 months postoperatively

The OKS scores for the JII-BCS and Genesis II groups were mean (SD) 42.97 (5.21) and 43.13 (5.20), respectively. There was no significant difference between the groups: adjusted effect size 0.35 (−2.01,2.71) p=0.771 ( table 2 ).

Oxford Knee Scores (OKS, primary outcome), from baseline to 6 months after surgery (primary time point)

Secondary outcome comparisons: 6 months postoperatively

There were no differences between the two groups for any of the secondary patient reported outcomes ( online supplemental tables S1 ).

There was no difference between the JII-BCS and Genesis II groups in the time to complete the TUG Test or the distance covered in the 6 min walk test ( online supplemental table S2 ). The Star-Excursion Test was attempted by all participants but 59% of participants at baseline, 59% at follow-up and 63% at outcome were unable to complete it ( online supplemental table S3 ). Therefore, statistical analysis was not undertaken.

The primary movement performance measures are reported in table 3 . In summary at 6 months postsurgery, the Genesis II group had a significant advantage for knee ROM and peak knee flexion angular velocity during walking. There were no differences between the groups for walking speed or peak flexion angular knee velocity on stair climbing.

Movement performance primary measures during walking from baseline to 6 months postsurgery (primary time point): walk speed, step length symmetry, knee range of motion (ROM) and peak knee flexion angular velocity

Data for all secondary movement performance measures are provided in online supplemental tables S4–S8 . The only difference between groups that reached statistical significance was for COP path length in double stance with eyes closed ( online supplemental table S7 ). The mean (SD) values for the Genesis II and JII-BCS groups were 158.14 (65.40) mm and 235.48 (176.94) mm, respectively. Adjusted effect size was −59.91 (–105.98, –13.85) p=0.01 in favour of the Genesis II group.

Postoperative clinical context

There were no between-group significant differences for: length of stay, change in pain medication from randomisation or physiotherapy received ( online supplemental tables S9 and S10 ).

Adverse events

One patient with a JII-BCS developed acute swelling and pain in the knee and was systemically unwell at 4 months postoperatively. The joint aspiration demonstrated turbid fluid and an exchange of the polyethylene spacer and retention of the femoral and tibial components (Debridement And Implant Retention) was performed with postoperative antibiotic treatment. Subsequent microbiology was negative so infection was never conclusively demonstrated. The numbers and type of complications are reported in online supplemental table S11 .

The findings do not support the hypothesis that the JII-BCS produces a better outcome than the Genesis II for the primary outcome of the OKS at 6 months after surgery. No differences between groups were also found for: other patient-reported outcomes; measures of balance and walking function; hip and ankle ROM; knee moments during walking; double support time during walking and percentage of gait cycle for peak muscle activation. However, significant advantages for the control group (Genesis II) were found for: operated knee range-of-movement and peak knee flexion angular velocity during walking, and postural control (COP path length).

While some investigators have demonstrated differences between generations of knee designs 12 not all modern generation TKR designs have demonstrated an improvement in outcomes when compared with their predecessors. 15–20 48 One possible reason for this is that the predecessor is already producing good results and therefore is difficult to improve on. Regarding the JII-BCS, at the time of writing, only Bialy et al 45 have directly compared the Genesis II and the JII-BCS. Their study was non randomised and consisted of 18 patients between the two groups. They reported a greater supine range of movement of the JII-BCS compared with the Genesis II when measured with a long arm goniometer. They also reported an improvement in functional knee scores and stability when balancing. Their conclusions were that the JII-BCS restores more normal anatomy and kinematics which is correlates into the improvements that they found. None of the other papers reporting outcomes of the JII-BCS compared the JII-BCS to the Genesis II, none used a randomised design and none used methodology or outcomes that could be compared with the methodology used in this trial. 42–46 However, on the basis of the available literature, we measured outcomes that would be expected to be difference on the basis of the available literature, walking velocity, step-length symmetry (resulting from longer stride length), knee ROM and peak knee angular velocity.

Within our trial, we found differences in some biomechanical measures of motor impairment but not for others; patient-reported outcomes; and, walking and balance function. It is possible that knee range-of-movement during walking, walking symmetry, peak knee flexion angular velocity during walking and postural control (COP path length) are detecting motor impairment improvement for the Genesis II group and/or because statistical significance was a result of testing multiple outcomes. The latter explanation is clearly possible but knee range-of-movement is greater for people reporting good outcome after knee replacement than for those reporting poor outcome. 49 Moreover, knee range-of-movement has been found to be the main biomechanical effect of TKR 50 and to improve over time while other biomechanical measures do not. 50 51 Likewise, postural control improves over time 52 53 and approaches healthy control values. 52 Importantly, gait symmetry is an indicator of walking control 54 and, while of borderline statistical significance (p=0.05) can possibly detect differences following insertion of different prostheses. Peak knee angular velocity during walking is also an indicator of walking control 55 and has been found to change beneficially after insertion of the Genesis II prosthesis. 50 These findings indicate that secondary, in-depth, analysis of the biomechanical data should be undertaken.

A potential limitation is the relatively large number of secondary outcomes. However, this is also a strength as it ensured comprehensive examination of the potential impact of TKR on functional ability, motor impairment and health-related quality of life. Another potential limitation is that the surgeons all had a much greater familiarity with the Genesis II implants. However, all surgeons were very experienced with the Genesis II implant with at least 10 years of experience implanting the device. All surgeons received thorough training with the JII-BCS and the surgical technique and instrumentation are similar for both devices with only one additional femoral cut being necessary for the JII-BCS compared with the Genesis II. A key strength of this trial is that the required sample size was achieved with only one person lost to follow-up. Other strengths include minimisation of selection bias through a robust randomisation procedure and use of double blinding to minimise interpretation bias.

The lack of difference between implant designs is important for patients, surgeons, healthcare providers and implant companies. For the patient and surgeons, reassurance can be gained that older designs, with proven track record of function and survivorship, can provide the same patient reported and functional outcome as more modern designs. For the healthcare providers, older implants are often less expensive and, in the absence of clinical benefit with and demonstrable longevity, if the additional expenditure on more modern designs is avoided for the hundreds of thousands of patients undergoing surgery worldwide the cost savings are potentially significant. Finally, for the implant companies, it is more likely than not than implant design has reached a point when non-implant-related factors play a more important role in patient outcome. The future of design and innovation may come in the form of more modern surgical techniques such as robotic assisted implantation to assist in placing the knee in a more kinematically sympathetic position which in turn may allow the newer design philosophies to positively influence outcome. It is possible, only then in combination with modern surgical techniques, that improvements in patient outcomes can be realised but well-constructed surgical trials will need to answer such questions.

This study demonstrated no difference between the Genesis II and its successor the JII-BCS for PROMS, walking function, temporal-spatial gait parameters, balance ability and lower limb kinematic results at 6 months follow-up. However, significant advantages were seen in for the Genesis II in the operated knee range-of-movement, peak knee flexion angular velocity during walking and postural control.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

This study involves human participants and was approved by East of England – Cambridge Central Research Ethics Committee (reference 16/EE/0230). Participants gave informed consent to participate in the study before taking part.

Acknowledgments

The team would like to thank all the participants and families who gave their time to be part of this study; Antony Colles, Martin Pond and the NCTU data management team; Estelle Payerne; Amanda Thacker; NNUH sponsorship team and the safety monitoring committee members, Prof Marcus Flather and Prof Simon Donell. Also: Mr Charles Mann, Mr Nish Chirodian, Mr David Calder, Dr Nicola Hancock, Nursing and clinic staff at the Spire Hospital and NNUH, Prof Andoni Toms and the Radiology department at NNUH and Addenbrooke’s hospital, Cambridge, Dr Simon Horton and Dr Anne Killett

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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

Data supplement 1

Twitter @tobyosmith

Contributors IM and VP drafted this paper. IM is the guarantor. All authors (IM, VP, ABC, GC, CW, JW, BH, TOS, JH and AMS) contributed to revisions of the manuscript, read and approved the final manuscript. All authors (IM, VP, ABC, GC, CW, JW, BH, TO, JH and AMS) contributed to the development of the trial protocol as well as conception or design of the work; the acquisition, analysis or interpretation of data for the work.

Funding This work was supported by an investigator initiated grant from Smith and Nephew, with both types of knee replacements supplied at the same cost.

Disclaimer The funders had no role in the design of the study, the data collection, the data analysis, interpretation of data, or writing of the manuscript.

Competing interests The trial was funded by Smith and Nephew via an unrestricted grant, administered by the Sponsor NNUH. Funding was used within NNUH for running the trial. Funds were provided via NNUH to UEA for the members of the trial team based in the movement and Exercise Laboratory (MoveExLab) at UEA and the clinical trials unit (CTU) based at UEA for statistics, and trial and data management.

Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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The Journey Bicruciate Knee Replacement: Design Modifications Yield Better Early Functional Results and Reduce Complications

Affiliation.

1 Lower Limb Arthroplasty Unit, Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom.
PMID: 33111275
DOI: 10.1055/s-0040-1718599

The Journey-I total knee replacement was designed to improve knee kinematics but had several complications including early dislocation. The Journey-II modification was introduced to reduce these while maintaining high function. To assess whether the modified Journey-II prosthesis has succeeded in its designers aims, we undertook an observational study of prospectively recorded data to analyze and compare the two knees. A total of 217 Journey-I and 129 Journey-II knees were identified from the department's prospectively collated registry and were assessed at 1 year by a comparative statistical analysis using numerous factors including pain, functional activity, physical assessment, Short Form-12 (SF-12), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and Oxford scores. The statistical tests included Chi-square, Wilcoxon's rank and Mann-Whitney U -tests with the level of significance set at p < 0.05. There was a variation in primary patella resurfacing between the two groups with 14.3% in the Journey-I cohort and 66.7% in the Journey-II cohort. Both replacements demonstrated excellent postoperative function, but the Journey II performed significantly better than Journey I with fewer complications (37 vs. 10) and better improvement in almost all clinical scores including pain ( p < 0.01), mobility outcomes ( p = 0.018), Oxford ( p = 0.004), and WOMAC ( p = 0.039) scores but not with flexion improvement and SF-12 score. There was significant improvement in patellofemoral pain postoperatively in both the Journey I ( p = 0.011) and Journey II ( p = 0.042) arthroplasty; however the primarily resurfaced patella in a Journey-II implant had better postoperative scores. The main complication of dislocation in the Journey I was not seen in the modified Journey-II implant with stiffness requiring intervention reduced in Journey II. These results suggest that the Journey II has improved short-term clinical outcomes compared with Journey I with reduction of dislocation and other complications.

Publication types

Observational Study
Arthroplasty, Replacement, Knee* / adverse effects
Arthroplasty, Replacement, Knee* / methods
Joint Dislocations* / surgery
Knee Joint / surgery
Knee Prosthesis*
Osteoarthritis, Knee* / surgery
Patella / surgery
Treatment Outcome

NAVIO ◊ Partial Knee Replacement Surgery
NAVIO ◊ Total Knee Replacement Surgery
VERILAST Knee Technology

JOURNEY II Total Knee Replacement

Before Surgery
Day of Surgery
After Surgery
Patient Forms (Read Only)
Billing Information
Good Faith Estimate
Your Rights and Protections Against Surprise Medical Bills
Patient’s Rights and Responsibilities
Advance Directives
Helpful Reminders
In the News

(414) 384-6700
Patient Portal

The JOURNEY DEUCE, an exciting new alternative to total knee replacement

Because of the new technology used in the JOURNEY DEUCE system, patients with knee arthritis isolated to just part of their knee–thought to be as many as 70% of knee replacement patients–now have an “early intervention” surgical option to end their debilitating pain.

This minimally invasive partial knee replacement provides many potential benefits for patients, including:

The preservation of healthy, non-arthritic bone that would otherwise be sacrificed during total knee replacement. In fact, the procedure allows for the preservation of a full 50% of the bone traditionally removed during total knee replacement.
Your ACL and PCL (anterior cruciate ligament and posterior cruciate ligament) are preserved. These ligaments provide natural stability during physical activity, such as walking, climbing stairs or simply standing up from a seated position. Patients who have received a traditional total knee replacement often notice a difference in stability during these activities.

KEY FACT: If the JOURNEY DEUCE implant needs to be replaced later in life, it can be swapped out for a regular, or “primary,” knee replacement implant rather than a larger, more invasive total knee “revision” system.

JOURNEY DEUCE System Benefits Compared to Traditional Total Knee Replacement

A potentially smaller incision
Preservation of all ligaments of the knee
Preservation of bone that would otherwise be removed during total knee replacement surgery
Decreased blood loss
Decreased post-operative pain
Reduced post-operative medication
Faster rehab/recovery time

Frequently Asked Questions

How do I know if I am a candidate for this surgery?

The JOURNEY DEUCE procedure may be a viable treatment option if you have arthritis in only two of the three compartments of your knee – most likely the patellofemoral and medial (inside) compartments. When only these portions of the joint are damaged, and your surgeon has determined that you have adequate ligament stability, he or she may opt to replace only this diseased portion of your knee. The healthy compartment remains untouched.

Can I resume my normal activities?

Most patients can resume normal activities following the minimally invasive JOURNEY DEUCE procedure once they have regained adequate strength and flexibility, and their surgeon has released them to begin normal activities. However, any activity that results in repetitive joint trauma such as running, jumping or twisting should be avoided. Most patients who have recovered from this procedure have returned to such activities as golf, doubles tennis, dancing, swimming or gardening.

How long will my knee implant last?

It is very difficult to predict the lifespan of any individual knee implant. However, a good surgical technique and accurate instrumentation, combined with proper patient selection and postoperative compliance, improve the chances of achieving years of pain free physicalactivity.

This web site contains general medical information and does not replace the medical advice of your physician. If you have questions about your medical condition or exercises, ask your doctor or health care provider.

Please contact our office at (414) 384-6700 for more assistance or to set up an office consultation to be evaluated for new exciting treatment on the cutting edge of orthopedics and sports medicine.

Study protocol
Open access
Published: 24 February 2020

CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial

Celia Clarke ORCID: orcid.org/0000-0001-6584-9601 1 ,
Valerie Pomeroy 1 ,
Allan Clark 2 ,
Graham Creelman 3 ,
Nicola Hancock 1 ,
Simon Horton 1 ,
Anne Killett 1 ,
Charles Mann 4 ,
Estelle Payerne 5 ,
Andoni Toms 2 , 6 ,
Gareth Roberts 3 ,
Toby Smith 1 , 7 ,
Ann Marie Swart 2 &
Iain McNamara 2 , 4

Trials volume 21 , Article number: 222 ( 2020 ) Cite this article

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Metrics details

Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKRs; the JOURNEY II Bi-Cruciate Stabilised knee arthroplasty, a newer knee prosthesis designed to provide guided motion and improve knee kinematics by more closely approximating a normal knee, and the GENESIS II, a proven existing design.

To compare the change in Patient-reported Outcome Measures (PROMs) scores of the JOURNEY II BCS and the GENESIS II from pre-operation to 6 months post operation.

CAPAbility is a pragmatic, blinded, two-arm parallel, randomised controlled trial recruiting patients with primary osteoarthritis due to have unilateral TKR surgery across two UK hospitals. Eligible participants ( n = 80) will be randomly allocated to receive either the JOURNEY II or the GENESIS II BCS knee prosthesis. Baseline measures will be taken prior to surgery. Patients will be followed at 1 week, 6 to 8 weeks and 6 months post-operatively. The primary outcome is the Oxford Knee Score (OKS) at 6 months post-operatively. Secondary outcomes include: other PROMs, biomechanical, radiological (computerised tomography, (CT)), clinical efficacy and safety outcomes. An embedded qualitative study will also investigate patients’ perspectives via interview pre and post surgery on variables known to affect the outcome of TKR surgery. A sub-sample ( n = 30) will have additional in-depth interviews to explore the themes identified. The surgeons’ perspectives on the operation will be investigated by a group interview after all participants have undergone surgery.

This trial will evaluate two generations of TKR using PROMS, kinematic and radiological analyses and qualitative outcomes from the patient perspective.

Trial registration

International Standard Randomised Controlled Trials Number Registration, ID: ISRCTN32315753 . Registered on 12 December 2017.

Peer Review reports

Introduction

Background and rationale.

Osteoarthritis of the knee is a common musculoskeletal condition. The surgical management of painful, end-stage osteoarthritis is by total knee replacement (TKR) which should be considered before there is prolonged and established functional limitation and severe pain [ 1 ]. Over 100,000 TKRs were performed in the UK in 2019 [ 2 ]. While TKR frequently reduces pain and improves physical function in the majority of patients, 20% of patients report poor functional outcomes post-operatively [ 3 , 4 ]. Such poor outcomes are of importance to patients and have a considerable financial and service-provision impact on NHS care. Research is needed to improve post-arthroplasty outcomes for those patients.

There is a paucity of literature regarding the kinematic outcomes of patients following TKR. However, there is uncertainty as to whether good Patient-reported Outcome Measures (PROMs) are associated with a return to normal kinematics of the TKR knee compared to the native knee. Movement analysis can be used to examine the change in kinematics before and after TKR by examining functional movements in activities of daily living.

The long-term success of TKR depends largely on correct component alignment and accurate ligamentous balancing [ 5 ]. The impact of femoral- and tibial-component rotation on flexion-gap balance, patellofemoral tracking and normal kinematic function is well-known [ 6 , 7 , 8 ]. Complications secondary to poor component alignment have been reported to lead to a higher rate of revision surgery [ 9 , 10 ]. Computerised tomography (CT) imaging is a valid and reproducible technique for accurately measuring TKR-component rotation [ 11 , 12 ]. However, despite CT being widely used to examine implant rotation, the correlation between rotational alignment, PROMs and kinematic function comparing pre- and post-operative measurement is unclear [ 13 , 14 ]. It is hypothesised that patients with poor rotational profile post-operatively compared to their pre-operative values will have significantly worse PROMs, movement parameters and patient satisfaction.

We report the protocol of a two-group, parallel randomised controlled trial (RCT) comparing patient-reported, surgical and biomechanical outcomes from a TKR of a newer design (the JOURNEY II Bi-Cruciate Stabilised knee arthroplasty (BCS)) designed to provide improved kinematic outcomes compared to an older design TKR implant (the GENESIS II).

This protocol (version 2.4, dated 27 February 2019) has been written and reported according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidance and Checklist [ 15 ] (see Additional file 1 : SPIRIT 2013 Checklist).

The principal aim of the trial is to compare the change in PROMs scores of the JOURNEY II BCS knee and the GENESIS II knee from pre-operation to 6 months post operation. Additional aims are as follows:

To determine whether the temporal and spatial parameters of gait, the range of movement and static and dynamic balance are closer to aged-matched normative data in those receiving the JOURNEY II BCS compared to those receiving the GENESIS II knee

To monitor the change in function (Aim 1 above) and PROMs of the JOURNEY II BCS and the GENESIS II knee from post operation to 6 months post operation

From CT scan measures, determine anatomical landmarks and rotational profile around the native knee and following TKR to ascertain the component rotational position post-operatively compared to anatomical landmarks

To examine the relationship between rotational values determined by CT scanning with pre- and post-operative PROMs and movement analysis

To develop knowledge and understanding of patient and surgeon experiences, perspectives and satisfaction when receiving or implanting the JOURNEY II BCS compared with the GENESIS II knee, and their experiences of recovery and rehabilitation

Methods: participants, interventions and outcomes

Trial design.

This is a pragmatic, triple-blinded, parallel, superiority, randomised controlled trial of the JOURNEY II BCS (intervention) versus GENESIS II (control) in patients with primary osteoarthritis undergoing TKR. Embedded in the clinical trial is a qualitative investigation of participants’ confidence in the TKR received and their experiences of the recovery process in the first 6 months after surgery. The aim of this is to identify any differences in the experience of recovery between each type of TKR. Surgeons will also be interviewed to investigate their perceptions of the surgery and patient’s rehabilitation.

The trial outline is illustrated in Fig. 1 .

Comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability (CAPAbility) trial outline

Study setting

Trial sites were pre-selected on the basis of their locality to facilitate data collection (namely the kinematic assessment). Sites include the Norfolk and Norwich University Hospital (NNUH), where all patients recruited to the trial will be referred for consideration of TKR. The NNUH refers a proportion of its TKR patients to Spire Norwich where the operation and follow-up physiotherapy is delivered. Both hospital are participating in this trial. All CT scans will be performed at NNUH. The biomechanical assessment will be undertaken in a specialist movement analysis laboratory (MoveExLab) at the University of East Anglia (UEA).

Eligibility criteria

To be eligible for the trial, patients must satisfy the surgeon’s general requirements for a TKR, meet all inclusion criteria and none of the exclusion criteria listed in Table 1 .

Patients will be excluded if they are currently enrolled on an interventional trial involving surgery, exercise or rehabilitation. Patients can be co-enrolled into studies given prior agreement from the Trial Management Group (TMG) of both studies. Patients who enter the study are eligible for entry onto the UK National Joint Registry.

Potential participants will be approached via a single route. Potential participants will be screened by a member of the clinical team in collaboration with research nurses after having been added to the orthopaedic clinic waiting list. Potentially eligible patients who meet the eligibility criteria will either be handed a Patient Information Sheet (PIS) if still at the clinic, or be posted an invitation letter informing them that the trial is taking place and include the PIS. After having been provided the trial PIS, potential participants will be telephoned by a research nurse. To minimise the possibility of attrition, appointments for outcome measures will be agreed with participants when they enter the trial. In addition, members of the research team will maintain regular contact with participants to ensure attendance at follow-up visits and to monitor any adverse events (AEs).

Informed consent

Written informed consent to enter and be randomised into the trial will be taken by a member of the clinical team and obtained from participants after explanation of the aims, methods, benefits and potential hazards of the trial. Potential participants will be given as much time as they need to consider whether or not to provide informed consent. Consent will take place before any trial-related measures, at a time convenient to the potential participant, preferably at a time to combine with one or more of the measures to reduce participant visits.

If a participant withdraws prior to surgery, an additional participant will be randomised to ensure that 80 participants complete the surgery.

Patients who, in the opinion of the clinical team, do not have capacity to consent, will be ineligible. If a participant loses capacity during the course of the trial, they will be withdrawn from any further assessments, but any data already collected will be retained. Consent will be re-sought if new information becomes available that affects the participant’s consent in any way. This will be documented in a revision to the PIS and the participant will be asked to sign an updated consent form. These will be approved by the Ethics Committee prior to their use. A copy of the approved consent form is available from the Norwich Clinical Trials Unit (NCTU).

Sample size

Eighty patients will be recruited onto this superiority trial. The sample size has been calculated from the Oxford Knee Score (OKS) [ 16 ]. The OKS ranges from a score of 12 to 60, with 12 being the best outcome. The minimally important clinical difference for OKS is 5 [ 17 , 18 ] and a standard deviation of 7.4 [ 19 ]. For an 80% power, and an assumed dropout rate of 10%, 80 participants will be randomised to one of the two groups.

Participant timeline

The participant timeline is shown in Fig. 1 . Where possible, trial visits will be combined with standard clinic visits. Should additional visits be necessary, participants will be reimbursed for travel costs.

Interventions

All participants will receive routine care provided by the NHS. Pre-operative and peri-operative care is standardised irrespective of implant.

Explanation for choice of comparators (Genesis II versus JOURNEY II BCS)

The GENESIS II TKR system made by Smith and Nephew (Smith and Nephew plc, Watford, UK) is frequently used in standard practice within the NHS [ 2 ]. It has been the standard TKR within the NNUH and Spire Norwich Hospitals for over 10 years. The Genesis II has a survivorship of over 93% of implants at 15 years [ 2 , 20 ] and offers good health-related quality of life outcomes [ 21 ].

A newer device, JOURNEY II BCS, also manufactured by Smith and Nephew, has been developed to theoretically provide improved kinematic outcomes compared to the GENESIS II [ 22 ]. These improvements are proposed to include:

Alteration in the dimensions of the femoral component to reduce soft-tissue strain and maintain more natural translation and external rotation

Reduction in the thickness of the lateral and medial anterior flange of the femoral component and edge tapering to reducing tension on the iliotibial band (ITB) and iliotibial-patellar bands (ITPB)

Reduction in the width of the femoral component to limit implant overhang, and reduction in the mid-flexion thickness of the medial condyle to maintain more consistent strain on the medial collateral ligament (MCL) throughout the flexion range

A superior cam position, which serves to decrease femoral rollback in the targeted ranges of motion, increase femoral external rotation, and lower the point of tibial post contact in deep flexion

While there is fluoroscopic data to support normal kinematics in early and late flexion [ 23 ], there is a paucity of evidence exploring these hypotheses for this newer implant.

Surgical flow and training

Surgeons will be high-volume arthroplasty surgeons who work at both NNUH and Spire Norwich Hospital. The standard implant at both sites is the Genesis II TKR system. All surgeons have used this implant for many years and are very familiar with the surgical technique. All surgeons and theatre staff have received training on the implantation of the JOURNEY II BCS implant. All surgeons have undergone training on the JOURNEY BCS II implant in a cadaveric laboratory and have also undertaken a learning curve with the device until they were confident with the technique. This was supported by a Smith and Nephew representative. There are minimal differences in the surgical cuts and technique between the Genesis II and the JOURNEY BCS II. Participating surgeons felt that there was a shallow learning curve to the JOURNEY BCS II. Both devices are CE-marked and will be used within indication. Smith and Nephew are providing the JOURNEY II BCS at the same price as the GENESIS II system for this study.

Surgical procedures

Devices will be identified and prepared for the operation by a surgical technician at the surgery site.

Participants allocated to the intervention device will receive the JOURNEY II BCS prosthesis while participants allocated to the control condition will receive the GENESIS II prosthesis. The type of device implanted and its serial number will be recorded on the trial database, by an unmasked member of the research team.

The surgical procedure will follow the standardised surgical approach and technique. It will be undertaken through a medial parapatellar approach. In both implants and in every case to ensure standardisation of technique, a posterior stabilised prosthesis with patella resurfacing will be used.

It is possible that a decision will be taken prior to, or during, the operation not to use the allocated device if, in the opinion of the surgeon, the patient is found to have become unsuitable for continued participation in the trial. The reasons for an allocated device not being used will be recorded on the trial database. In this case or if a participant chooses to withdraw consent for treatment, or follow-up, all data collected up to the point of withdrawal will be retained. The standard Norwich Enhanced Recovery Programme (NERP) [ 24 , 25 ] is used for the anaesthetic technique and post-operative recovery.

Post-operative rehabilitation

Post-operative rehabilitation will follow routine clinical care at NNUH and Spire Norwich [ 24 , 25 ]. While an inpatient, participants will be seen by a physiotherapist for routine care at least twice daily to progress on a tailored gait re-education and exercise programme during their hospital admission. This will be recorded in an in-patient hospital rehabilitation log. Once safe for discharge, patients will be asked to continue a home exercise programme and gait re-education. This will consist of daily (advised) knee-flexion range-of-motion exercises and quadriceps strengthening.

At week 4 post-operatively, all participants will attend an exercise-group-based intervention delivered by a qualified physiotherapist and a physiotherapy assistant. These sessions will be used to increase participant’s knee range of motion, strength and overall confidence to undertake more strenuous exercises. Participants will attend this class weekly for two to six sessions depending on their need. All rehabilitation interventions will be recorded in a post-discharge rehabilitation log. Participants will be encouraged to continue their exercises which are prescribed within the group as part of a home-exercise programme.

No additional ancillary or post-trial care will be provided (in the absence of AEs) to trial participants.

The schedule of enrolment, interventions and assessment is shown in Table 2 . The PROMs will be administered by research nurses apart from the week-1 follow-up telephone call undertaken by the research associate performing the qualitative interview. The CT scans will be performed at the NNUH by research radiographers and reported by a consultant radiologist. The biomechanical assessments and qualitative interviews will be performed at the MoveExLab at the UEA. Participants who were unable to attend an assessment appointments were provided with an alternative appointment. If participants were unable to attend any alternative assessment appointments, PROMs data was collected during a telephone call to promotion participant retention and follow-up.

Primary outcome

The OKS [ 16 ] will be used to assess patient-reported functional status at 6 months post surgery.

Secondary outcomes: Patient-Reported Outcome Measures

The Oxford Knee Score (OKS) [ 16 ] – Activity and Participation Questionnaire (OKS-APQ), [ 26 ] EuroQol 5 dimensions, 5 levels health survey (EQ-5D-5 L) [ 27 ], UCLA Activity Score [ 28 ], Hospital Anxiety and Depression Score (HADS) [ 29 ], Forgotten Joint Score (FJS) [ 30 ], and 2-Item Pain Self-Efficacy Questionnaire [ 31 ].

Secondary outcomes: clinical efficacy outcomes

Clinical efficacy will be evaluated by:

Surgical-related parameters: need for revision surgery; length of hospital stay and change in pain medication will be collected during in-patient stay and at all the follow-up time points

Performance-related parameters: knee flexion and extension ranges of movement, measured at 6 to 8 weeks and 6 months post-operatively by the research associate in the MoveExLab (and by the research physiotherapist at baseline as part of routine care); timed-up-and-go (TUG) [ 32 ] and timed 6-minute walk test [ 33 ] recorded at the 6–8 week and 6-month time points by the research associate in the MoveExLab

Secondary outcomes: clinical safety outcomes

Complications related to the surgery (e.g. anaesthesia-related problems, bleeding, morbidities) will be collected from a notes review, prior to discharge, post-discharge, rehabilitation and follow-up. Additionally, at each visit, participants will be asked whether they have received additional treatment since their surgery/previous visit and what that consisted of.

Secondary outcomes: biomechanical outcomes

All biomechanical measures will be collected in the MoveExLab by the research associate. Three-dimensional motion capture using eight cameras (Vicon Motion System, Oxford, UK), three built in force plates (Bertec Corporation, Columbus, OH, USA) and surface electromyography (EMG) (Delsys, Natick, MA, USA). Participants will be unshod and asked to walk at their self-selected speed. A minimum of three heel strikes from each foot will be used to construct an average.

Overground walking: unshod and walking at self-selected speed:

Spatiotemporal parameters; speed, cadence, step-length, stride-length and symmetry

Kinematics of bilateral hip, knee and ankle joints

Kinetics: moments of bilateral hip, knee and ankle joints and ground reaction forces during the stance phase

EMG parameters: recruitment patterns of quadriceps: rectus femoris, vastus medialis and vastus lateralis, hamstrings: semitendinosus, biceps femoris, tibialis anterior, medial and lateral gastrocnemius

Stair ascent and descent:

Spatiotemporal parameters; speed, cadence, symmetry

Kinetics: moments of bilateral hip, knee and ankle joints and ground reaction forces from the bottom step

Static balance measures will be completed on a single, in-built force plate (Bertec Corporation, Columbus, OH, USA). Participants will be instructed to stand with their feet shoulder-width apart for double stance with their eyes closed and then open for 10 s. Three attempts will be recorded. Participants will then be instructed to stand on one leg in the centre of the force plate with their hands on their hips with their eyes open and closed for 10 s. Each limb will be tested. Three trials of 10 s will be recorded. The time will be stopped if the participant places the other foot on the floor. Each participant will be given six attempts at each position.

Static balance; measures of centre of pressure (CoP) from single- and double-leg standing

Anterior-posterior (AP), medial-lateral (ML) and CoP path length

AP, ML and CoP velocity

AP, ML and CoP range and standard deviation (SD)

Time-to-boundary (TTB) [ 34 ]

TTB minimum, mean and SD

Modified Star Excursion Balance Test (mSEBT) [ 35 ]

Anterior, posteromedial and posterolateral distance (millimetres) on both limbs

Secondary outcomes: radiological outcomes

Radiographs.

Pre-operative and post-operative conventional semi-flexed AP and lateral radiographs of the knee will be acquired.

Computerised tomography

A rotational-profile CT protocol will be acquired at the NNUH Radiology Department under standard operating procedure.

This will consist of three separate axial acquisitions through the femoral necks, knees and ankles reconstructed on bone and soft-tissue algorithms. The images through the knee will be split into two acquisitions according to the Berger protocol [ 36 ]. The pre-operative CT will be performed in the time after consent for the study and before TKR. The post-operative CT is not time sensitive and will be performed any time following surgery.

Two independent observers, radiologists under direct supervision of a senior musculoskeletal radiologist, will obtain the following measurements from the CT. In the case of disagreement between the two independent observers, through discussion, the senior musculoskeletal radiologist will act as adjudicator to ensure that agreement is met. Measurements will include:

Pre-operative

Femoral ante-torsion (degrees)

Tibial tubercle-trochlear groove distance (TT-TG) (millimetres)

Tibial torsion (degrees)

Post-operative

Femoral-component version (degrees)

Tibial-component version (degrees)

In the event of an incidental finding being reported, the clinical chief investigator will organise the necessary clinical follow-up which may include referral to an appropriate clinician and the organisation of further investigations.

Secondary outcomes: qualitative study

Interviews will be completed either via a telephone call or face-to-face by the research associate. This flexibility was adopted to promote participant retention and complete follow-up. These interviews will be audio-recorded and transcribed for analysis.

All TKR participants will be invited to take part in an interview and complete a self-efficacy questionnaire and the HADS at baseline and a telephone call interview at the 7 days (± 2 days) surgery.

Two additional post-surgery interviews will be carried out with a purposive sample of participants ( n = 30), drawn equally from the intervention and control groups. Sampling decisions will be based on the following factors: age; sex; ethnicity; socioeconomic status; OKS; self-efficacy; expectations, mood and symptom management (as ascertained from inspection of baseline interviews).

The aims of the interviews are to gain in-depth understanding of patient perspectives on important variables known to affect outcomes of TKR surgery [ 4 , 37 , 38 , 39 ]. Specific themes will be:

To explore patients’ expectations of and hopes for surgery (pre-operative only)

To explore patients’ experiences and perspectives on: mood, pain and function – everyday mobility, participation in work, social roles and activities; surgery and post-operative clinical management; rehabilitation and recovery, and social support

All surgeons will be invited to consent to a face-to-face interview after the last participant’s surgery to explore their perspective on using each prostheses and their overall experience of surgery.

Methods: assignment of interventions

An interactive web-randomisation system will be used by a member of the research team who is not blinded to the intervention. Participants will be randomly assigned to either control or experimental group with a 1:1 allocation as per a computer-generated randomisation schedule. Randomisation will occur after the completion of all baseline tests. This will take place 4 days (± 3 days) prior to the operation to allow the correct TKR to be made available. Randomisation will be stratified by: (1) site (i.e. hospital where surgery is to take place); and (2) age (< 60 years = younger; equal or ≥ 60 years = older) [ 40 , 41 ].

Blinding (masking)

It is not possible to blind the surgeon to the trial intervention. However, the participants, the physiotherapists and all staff involved in assessing outcomes will be blinded. Processes will be in place to maintain blinding. These will include concealment in a sealed envelope of the surgery notes mentioning the prosthesis implanted in the patient file.

In the unlikely event of a research nurse accidentally becoming unmasked, the contacts, assessments and data entry for that participant will be undertaken by another member of the research team for the remaining period of trial participation for that participant. Accidental unmasking will be logged and monitored to ensure that the appropriate steps are taken to prevent a re-occurrence.

The clinical staff providing usual care will also be blinded. The decision to unmask a case will be made when knowledge of an individual’s allocated treatment is required to enable treatment of a serious adverse event (SAE) which is likely to be caused by the type of device implanted.

Where possible, requests for emergency unmasking of individuals will be made via the trial manager in agreement with the clinical chief investigator. However, in circumstances where there is insufficient time to make this request or for agreement to be sought, the treating clinician can make the decision to unmask immediately. This can be done via the trial database.

Methods: data management and analysis

Data management.

Each participant will be given a unique trial Participant Identification Number (PIN). Data will be entered under the participant’s PIN number onto the central database stored on the servers based at NCTU. Access to the database will be via unique, individually assigned (i.e. not generic) usernames and passwords, and only accessible to members of the CAPAbility trial team at NCTU, and external regulators if requested. The servers are protected by firewalls and are patched and maintained according to best practice. The physical location of the servers is protected physically and environmentally in accordance with UEA’s General Information Security Policy 3 (GISP3: Physical and environmental security).

The database and associated code have been developed by NCTU Data Management, in conjunction with the CAPAbility trial team. The database software provides a number of features to help maintain data quality, including; maintaining an audit trail, allowing custom validations on all data, allowing users to raise data-query requests and search facilities to identify validation failure/missing data. After completion of the trial, the database will be retained on the servers of NCTU for on-going analysis of secondary outcomes.

The identification, screening and enrolment logs, linking participant identifiable data to the pseudoanonymised PIN, will be held locally by the trial site. This will either be held in written form in a locked filing cabinet or electronically in password-protected form on hospital computers. After completion of the trial, the identification, screening and enrolment logs will be stored securely by the sites for 15 years unless otherwise advised by NCTU. The consent form will explain that if a participant wishes to withdraw from the study the data acquired prior to that point will be retained. Reason for withdrawal will be recorded, if given, as will loss to follow-up.

Statistical analysis

A full Statistical Analysis Plan (SAP) will be developed between the trial statistician and chief investigators and agreed with the trial’s Governance Committees. All analysis will be based on the intention-to-treat principle in which all participants will be analysed according to the group to which they were allocated, regardless of compliance.

Baseline factors will be summarised by group. All continuous variables will be summarised by the mean and SD, or if appropriate, the median and interquartile range. Categorical variables will be summarised with the number and percentage, in each category.

The primary comparison for OKS will be made using a general linear model with the stratification factors included as fixed effects. The difference between arms will be summarised using the mean difference, with 95% confidence intervals presented. A similar analysis will be undertaken for all other outcome measures.

For the temporal gait parameters and kinematic outcomes, each participant’s ‘closeness’ to age-matched normative data will be calculated. This will then be compared between groups using a general linear model with the stratification factors included as fixed effects. This data will also be presented graphically via scatter and distributional graphs to describe the deviations from the normative data.

For all the measures of movement listed, a general linear model with the stratification factors included as fixed-effects will be used to assess for between-group differences. If appropriate, adjusted analyses will be undertaken by including baseline factors and fixed effects in the above models.

Assumptions and sensitivity analysis

All the assumptions will be checked via distribution graphs and tests. If the assumptions are not valid, transformation will be considered. If none are found, a non-parametric approach will be used. The pattern of missing or incomplete data will be assessed. If appropriate, missing data will be imputed. The baseline comparability of the groups will be assessed. If appropriate, any factor found to be imbalanced and important, will be adjusted for in the analysis.

Exploratory subgroup analysis will be undertaken by including an interaction in the model to assess whether the effectiveness of the prosthesis is dependent on age or gender.

All analyses will be conducted using Stata and the full SAP will be produced, and approved, before any comparative analysis is undertaken.

Additional analyses – CT scans

All rotational profile measurements will be performed at NNUH under standard operating procedure on a full diagnostic workstation (Synapse DICOM viewer, Fujifilm, Japan; High resolution 2 K monitors, Radiforce RX340, Eizo, Mönchengladbach, Germany) in the bioimaging laboratory and under the supervision of a consultant musculoskeletal radiologist (AT).

Reproducibility

Inter-rater reliability will be assessed using intra-class correlation coefficients and 95% limits of agreement derived from Bland-Altman plots.

TKR alignment versus native landmarks

The difference between the post-operative component rotational alignment and the pre-operative native landmarks will be assessed using Bland-Altman plots.

Correlation with PROMS

The correlation between the PROMs and the difference between the post-operative component rotational alignment and the pre-operative native landmarks will be assessed using a correlation coefficient. A regression model will also be fitted including the randomisation group to allow for a potential between-group difference in PROMs.

Correlation with movement analysis

A similar analysis will be undertaken for the correlation between movement analysis and the difference between the post-operative component alignment and the pre-operative native landmarks.

Additional analyses – qualitative study

Interview transcripts will be organised using NVivo qualitative data management software (QSR International, Burlington, MA, USA). Analysis will follow qualitative content analysis procedures [ 42 ]. Coding and thematic analysis will be carried out independently by two experienced qualitative researchers. Trustworthiness strategies [ 43 ] will be used to increase the credibility, dependability and transferability of analysis and interpretation. This will include cross-checking and review of codes and themes; constant comparative method (hypothesis testing within and across the dataset) and deviant case analysis (the use of ‘outliers’ as a resource for understanding and interpretation of data) [ 44 ].

Analysis population and missing data

The analysis population is defined as:

Intention-to-treat: all randomised individuals

Per-protocol: all randomised individuals who do not have an alternative TKR during the follow-up period. Individuals will be included up to the point of the alternative TKR

Safety population: all randomised individuals who receive the TKR

Missing outcome data will be multiple imputed to increase precision of the treatment effect estimates. Sensitivity analyses will be conducted to assess the impact of the multiple imputations and a complete case analysis will also be conducted. All imputations will be examined to ensure that sensible values are being generated. Imputation models will contain baseline measures, outcome measures and factors predictive of missing data.

No interim analysis is planned for this study.

Methods: monitoring

Data monitoring.

A TMG has been convened to assist with developing the design, co-ordination and strategic management of the trial. A Safety Committee will review safety data and act in place of a Data Monitoring Committee (DMC). Monitoring activities will be undertaken both centrally and on site. The frequency, type and intensity of routine and triggered monitoring are detailed in the Quality Management and Monitoring Plan (QMMP). Ongoing central monitoring will ensure quality and consistency of data thorough the trial. Details about data collection and cleaning are described in the Data Management Plan (DMP).

Definitions of harm of the EU Directive 2001/20/EC Article 2 based on the principles of International Council for Harmonisation (ICH) guideline for Good Clinical Practice (GCP) apply to this trial. A record of all study-related SAEs, including details of the nature, onset, duration, severity, relationship to the device, relationship to the operative procedure, outcome and expectedness will be made on the relevant section(s) of the trial-specific SAE Form to be sent to the trial manager for onward reporting where required. SAEs resulting from surgery or arthroplasty complications (clinical and safety outcomes) will be reported in the relevant section of the Case Report Form (CRF).

All non-serious AEs and adverse drug events (ADEs), whether expected or not, should be recorded in the participant’s medical notes and also reported in the relevant section of the CRF.

Adverse events do not include :

Readmissions for revision surgery

Mild (i.e. not lasting for more than 5 days) anaesthetic-related complications: nausea, vomiting, dizziness, drowsiness, vaso-vagal drop, hypotension and constipation

Medical or surgical procedures; the condition that led to the procedure is the AE

Pre-existing disease or a condition present that was diagnosed before trial entry and does not worsen

Hospitalisation where no untoward or unintended response has occurred, e.g. elective surgery, social admissions

The Safety Committee will be provided with safety data for each treatment arm including related AEs. The Committee will advise on the continuation or early stoppage of the trial in the unlikely event that there are concerns over harm to participants. The medical care in response to any harm from the trial participation will be managed by routine NHS care.

The quality assurance (QA) and quality control (QC) considerations for the CAPAbility trial are based on the standard NCTU Quality Management Policy that includes a formal risk assessment, and that acknowledges the risks associated with trial conduct and proposals of how to mitigate them through appropriate QA and QC processes. Risks are defined in terms of their impact on: the rights and safety of participants; project concept including trial design, reliability of results and institutional risk; project management; and other considerations.

NCTU staff will review CRF data for errors and missing key data points. The trial database will also be programmed to generate reports on errors and error rates. Essential trial issues, events and outputs, including defined key data points, will be detailed in the trial DMP. The frequency, type and intensity of routine and triggered on-site monitoring will be detailed in the QMMP. The QMMP will also detail the procedures for review and sign-off of monitoring reports. In the event of a request for a trial-site inspection by any regulatory authority, NCTU must be notified as soon as possible.

Ethics and dissemination

Research ethics approval.

The trial is being conducted in accordance with CODEX rules and guidelines for research and the Helsinki Declaration as well as the ICH Guideline for GCP. The study protocol was approved by the East of England – Cambridge Central Research Ethics Committee (reference 16 /EE/0230) prior to the start of the trial. The trial is registered on the International Standard Randomised Controlled Trials Number (ISRCTN) registry (reference ISRCTN32315753). Approval was granted by the Health Research Authority (HRA) and Confirmation of Capacity and Capability to conduct the trial has been provided by the NNUH Research and Development Office.

The NNUH is the trial sponsor and has delegated responsibility for the overall management of the trial to the co-chief investigators (Co-CIs) and NCTU including the trial design, co-ordination, monitoring and analysis and reporting of results. The standard procedures and policies at NCTU, a UK Clinical Research Collaboration (UKCRC)-registered trial unit and the study’s QMMP are followed. A TMG, including lay membership, has been formed to assist with the design, co-ordination and strategic management of the trial. An independent Safety Committee has also been set up to provide oversight on the trial and to safeguard the interests of the participants.

Protocol amendments

The protocol was amended in August 2017 (before trial start at sites) to improve consistency and clarity. To that effect, an additional inclusion criterion was added to match the consent form requiring participants to agree to any incidental findings to be reported to their GP. The exclusion criteria relating to the use of the warfarin was also improved by the addition of novel anti-coagulants therapies which are increasingly being used. As part of this amendment we also changed the stratification criteria from American Society of Anesthesiologists (ASA) grade [ 45 ] and age to site and age as we became aware that ASA grading is highly subjective and has poor inter-rater reliability. We added the UCLA Activity Scale [ 28 ] as a secondary outcome measure to provide valuable information on the participant activity levels pre- and post-operatively. The HADS [ 29 ] was also added to be taken at baseline to inform the purposive sampling for the embedded qualitative study. Symptoms of anxiety and depression can impact the experience and perception of recovery. The embedded qualitative study was also simplified by the removal of the physiotherapists’ interview after agreeing that these would not add relevant information towards the outcome measure due to recall biases that would be introduced by practical aspects of running these interviews.

Further changes were made in June 2018 allowing further clarifications. This was done following the removal of the Body Mass Index (BMI) requirement enforced by one of our surgery sites. The associated exclusion criteria could, therefore, be removed opening the recruitment to a wider population and thus improving the representativeness of the study sample as many patients have a BMI greater than 35. In addition to this, the criteria excluding prior knee surgery was refined to exclude only previous surgery of the collateral ligaments of the knee as previous surgery on the cruciate ligaments would not affect the trial outcome as these ligaments are to be removed during surgery. The clarification of this exclusion criteria also permitted for previous non-intra-articular knee surgery (e.g. minor procedures around the knee) which were excluded despite not affecting the trial outcome. The visit windows were also reviewed as part of these changes to increase the baseline window from − 21 days to − 42 days up to surgery and to change the 6-month visit time-frame from ± 2 weeks to + 4 weeks. The former ensuring enough time for the assessments to take place before randomisation and the latter that all participants would have a full 6-month rehabilitation period before undertaking the last follow-up visits. Additional changes included the addition of the learning curve details for surgeon training to perform the intervention, the addition of the process for participants to be informed of their knee allocation at the end of the trial as part of the result dissemination, the clarification of the non-adherence and non-retention section to confirm that any data collected up to a participant withdrawal will be retained and the clarification of the safety reporting period and responsibilities. This amendment also allowed us to update the compliance section to add the General Data Protection Regulation (GDPR) [ 46 ].

Following on the previous amendment, additional modifications were made in August 2018 after the agreement that the recruitment of patients with previous TKR could be allowed as long as they are over a year old at the time of the consultation and painless, mildly or moderately painful. This was agreed to create a more representative dataset while ensuring that these participants’ mobility will not be affected by contralateral pain.

Additional changes were made in December 2018 to include the maximum voluntary isometric contraction (MVIC) of the hamstring and quadriceps muscles on both limbs to assess the known issue of muscle strength loss after TKR [ 47 ]. This biomechanical measure evaluates post-operative quadriceps and hamstring muscle-strength loss and subsequent recovery in both the non-operative legs and healthy control legs for comparison. The inclusion criteria were also amended to remove ‘Patient willing to provide full informed consent to the trial, including consent for any incidental findings to be communicated to their GP’. This does not need to be an inclusion criterion as a potential participant would not be enrolled on the trial if the consent form, which includes a statement about communicating findings with the GP, was not initialled and signed. In addition the PIS was amended to clarify that baseline data collected for participants that may not progress to randomisation or surgery, for reasons other than withdrawal, will be retained and used as observational data.

Furthermore, the protocol was amended in March 2019 to extend the 6–8-week visit window to 6–10 weeks to ensure that all participants can be seen within the appropriate window. An additional time point for collecting changes in pain medication was also added to the participant timeline at discharge from surgery. This will allow for a comparison between the participant-reported pain medications at the Week-1 telephone call and what was prescribed at discharge.

Consent or assent

Potential participants will be provided with a PIS and given time to read it fully. Following a discussion with a medically qualified investigator or suitably trained and authorised delegate, any questions will be satisfactorily answered and if the participant is willing to participate, written informed consent will be obtained. During the consent process it will be made clear that the participant is free to refuse to participate in all or any aspect of the trial, at any time and for any reason, affecting their treatment.

Potential participants who, in the opinion of the clinical team do not have capacity to consent, will be ineligible for this study. If a participant loses capacity during the course of the trial, they will be withdrawn from the any further assessments but, the data which has already been collected will be retained.

Consent will be re-sought if new information becomes available that affects the participant’s consent in any way. This will be documented in a revision to the PIS and the participant will be asked to sign an updated consent form. These will be approved by the Ethics Committee prior to their use. A copy of the approved consent form is available from the NCTU trial team.

No additional consent will be sought for the collection or use of additional participant data or biological specimens as no such studies are planned.

Confidentiality

Any paper copies of personal trial data will be kept at the participating site in a secure location with restricted access. Following consent, identifiable data will be kept on the trial database to allow the MoveExLab staff to contact participants to arrange appointments. Only authorised trial team members will have password access to this part of the database.

Confidentiality of a participant’s personal data is ensured by not collecting participant names on CRFs and limiting access to personal information held on the database at NCTU. At trial enrolment, the participant will be issued a PIN and this will be the primary identifier for the participant, with secondary identifiers of month and year of birth and initials.

The participant’s consent form will carry their name and signature. These will be kept at the trial site, and a copy sent to NCTU for monitoring purposes. They will not be kept with any additional participant data.

Declaration of interests

The investigators named on the protocol have no financial or other competing interests that impact on their responsibilities towards the scientific value or potential publishing activities associated with the trial.

Access to data

Requests for access to trial data will be considered, and approved in writing where appropriate, after formal application to the TMG. Considerations for approving access are documented in the TMG Terms of Reference. The Co-CIs and trial statistician at NCTU will have access to the full trial dataset.

Dissemination policy

The results of the trial will be disseminated regardless of the direction of effect and will be reported following the Consolidated Standards of Reporting Trials (CONSORT) Statement [ 48 ]. Ownership of the data arising from the trial resides with the trial team. The publication policy will be in line with rules of the International Committee of Medical Journal Editors [ 49 ]. The TMG will decide on the dissemination strategy including presentations, publications and authorship.

This protocol describes a trial that will explore the performance and functional ability of two types of total knee implants by comparing them on multiple levels.

The use of validated PROMs as both primary and secondary outcomes will allow the comparison of the Journey II BCS and the Genesis II TKR implants in a standardised manner widely used in the literature. The addition of biomechanical, radiological, clinical efficacy and safety outcomes will permit an in-depth comparison of the implants and to fully assess the performance of both implants’ design in a comprehensive way. This will also highlight any relationships between each of these individual aspects and inform future study designs. The biomechanical outcome using everyday movement and detailed anatomical information from the rotational profile will both provide invaluable and pragmatic information on the knee implants in situ which will help clinicians in the investigation and management of participants before and after TKR. Additionally, the embedded qualitative study will investigate not only participant-related constructs associated with both their TKR and rehabilitation but also provide surgeon’s perspectives.

One of the challenges linked with the collection of varied outcome measures is the participant visit burden. This has been considered very carefully and the trial has been designed for study visits to be combined with routine clinical visits or to be undertaken over the telephone.

Availability of data and materials

Public access to the full trial protocol, trial-related documents, participant-level dataset and statistical code may be made on request to the TMG.

Abbreviations

Adverse drug events

Adverse events

Bi-Cruciate Stabilised knee arthroplasty

Co-chief investigator

Consolidated Standards of Reporting Trials

Centre of pressure

Case Report Form

Data Monitoring Committee

Electromyography

Forgotten Joint Score

Good Clinical Practice

General Data Protection Regulation

General Information Security Policy 3

Hospital Anxiety and Depressions Score

Health Research Authority

International Council for Harmonisation

International Standard Randomised Controlled Trials Number

Movement analysis laboratory

Modified Star Excursion Balance Test

Norwich Clinical Trials Unit

Norwich Enhanced Recovery Programme

National Institute for Health and Care Excellence

Norfolk and Norwich University Hospital NHS Foundation Trust

Oxford Knee Score

Oxford Knee Score Activity and Participation Questionnaire

Principle investigator

Participant Identification Number

Patient Information Sheet

Patient-reported Outcome Measures

Quality assurance

Quality control

Quality Management and Monitoring Plan

Range of Movement

Serious adverse events

Statistical Analysis Plan

Total knee replacement

Trial Management Group

Time-to-boundary

UK Clinical Research Collaboration

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Acknowledgements

The authors are thankful for the ongoing support from the trial participants, site staff and NCTU team undertaking various aspect of the CAPAbility trial. We would also like to express our gratitude to the TMG for its review of the protocol and the Safety Committee members (Professor Simon Donell and Professor Marcus Flather) for their oversight of the trial.

Trial status

Recruitment opened on 14 May 2018. The first participant was recruited on 25 May 2018. The current protocol is version 2.4 dated 27 February 2019. Recruitment is expected to be completed by the 11 October 2019.

The CAPAbility trial is an investigator-initiated trial funded by Smith and Nephew (JOURNEY BCS II and GENESIS II implant manufacturer) apart from the embedded radiological study (radiological outcomes measures from rotational CT scans) which is funded by the Gwen Fish Orthopaedic Trust.

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Celia Clarke, Valerie Pomeroy, Nicola Hancock, Simon Horton, Anne Killett & Toby Smith

Norwich Medical School, University of East Anglia, Norwich, UK

Allan Clark, Andoni Toms, Ann Marie Swart & Iain McNamara

Patient and Public Involvement, Norwich, UK

Graham Creelman & Gareth Roberts

Department of Trauma and Orthopaedics, Norfolk and Norwich University Hospital, Norwich, UK

Charles Mann & Iain McNamara

Norwich Clinical Trials Unit, UEA, Norwich, UK

Estelle Payerne

Norwich Radiology Academy, Norfolk and Norwich University Hospital, Norwich, UK

Andoni Toms

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

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Contributions

CC, EP, TS and IMN drafted this paper. All authors contributed to revisions of the manuscript and read and approved the final manuscript. All authors contributed to the research funding application and development of the trial protocol. All authors read and approved the final manuscript. CC is the corresponding author.

Corresponding author

Correspondence to Celia Clarke .

Ethics declarations

Ethics approval and consent to participate.

The study protocol was approved by the East of England – Cambridge Central Research Ethics Committee (reference 16 /EE/0230) prior to the start of the trial. The trial is registered on the International Standard Randomised Controlled Trials Number (ISRCTN) registry (reference: ISRCTN32315753). Approval was granted by the Health Research Authority (HRA) and Confirmation of Capacity and Capability to conduct the trial has been provided by the NNUH Research and Development Office. Informed consent will be obtained from all study participants.

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Not applicable

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The authors declare that they have no competing interests.

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Supplementary information

Additional file 1..

Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Checklist.

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Clarke, C., Pomeroy, V., Clark, A. et al. CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial. Trials 21 , 222 (2020). https://doi.org/10.1186/s13063-020-4143-4

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Received : 12 August 2019

Accepted : 05 February 2020

Published : 24 February 2020

DOI : https://doi.org/10.1186/s13063-020-4143-4

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Total knee arthroplasty
Knee replacement
Functional ability
Knee prosthesis
Primary osteoarthritis

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IMAGES

Smith & Nephew Releases JOURNEY II XR Total Knee Arthroplasty
JOURNEY™ II BCS Knee System demonstrates improved patient outcomes and
Smith+Nephew Unveils JOURNEY II ROX Total Knee
JOURNEY II TKA Animation 71282017
JOURNEY™ II BCS Knee System demonstrates improved patient outcomes and
Journey II Full Knee Replacement Surgery

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BETTER KNEE Extension After Surgery with JAS Device
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Is A Partial Knee Replacement Better Than A Total Knee Replacement?
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COMMENTS

JOURNEY II TKA
JOURNEY II Total Knee Arthroplasty. Total knee arthroplasty patients report unmet levels of satisfaction, particularly for more active or demanding activities. 1,2 The JOURNEY II System is designed to help patients rediscover their normal through a smoother recovery, *3,4 improved function *4-8 and higher patient satisfaction *2,4-6. Brochure.
JOURNEY II
The JOURNEY II BCS Knee. Recent advances in biomedical engineering software have opened a new chapter on high performance knee implants. One remarkable breakthrough has been the creation of the JOURNEY II BCS knee, a second-generation knee replacement that combines the stability and natural motion of the human knee with new low-friction materials that may extend the life of the implant.
The Journey II Total Knee System: A Step Ahead
The normal knee, however, does not function like a hinge. Instead, as it bends and straightens, there is flowing rotation and front to back sliding to its kinematics. Only the Journey II TKA recreates these kinematic movements. 2. ALTERED ANATOMY: With conventional knee replacement surgery, anatomy of the knee is altered in several ways. When ...
JOURNEY II Active Knee Solutions: Knee Replacement Surgery
Learn about the JOURNEY II Active Knee Solutions, a unique total knee implant that addresses implant wear and implant feel. This site provides information for patients who are interested in learning more about this innovative design and its benefits.
JOURNEY II Total Knee
JOURNEY™ II. Journey II Total Knee System. For orthopaedic surgeons seeking treatment solutions beyond traditional knee replacements, JOURNEY II Active Knee Solutions has been engineered to empower patients with a renewed right to an active lifestyle by breaking through traditional knee replacement barriers and delivering Function, Motion, and Durability through PHYSIOLOGICAL MATCHING
Knee Replacement
Dr. Jeffrey Carroll talks about knee replacement and the advantages of the Smith & Nephew Journey II XR.
Smith+Nephew announces first surgery for its JOURNEY™ II Medial Dished
It allows me to optimize the kinematics for my patient's while also providing good stability in either a cruciate-retaining or cruciate-sacrificing total knee replacement procedure." JOURNEY II MD ...
JOURNEY II XR
The JOURNEY II XR implant addresses durability with a combination of two wear reducing materials - the proprietary OXINIUM metal alloy and a highly cross-linked plastic insert - that were designed to address wear on both surfaces of the implant. Because it is twice as hard as cobalt chrome, the most commonly used metal in knee implants ...
McKinley Orthopedic
The JOURNEY II BCS Knee . Recent advances in biomedical engineering software have opened a new chapter on high performance knee implants. One remarkable breakthrough has been the creation of the JOURNEY II BCS knee, a second-generation knee replacement that combines the stability and natural motion of the human knee with new low-friction materials that may extend the life of the implant.
JOURNEY II Knee Replacement Technology: Knee Implant Wear
The data showed that after 5 million cycles, the LEGION CR Knee made with the combination of our OXINIUM Technology and XLPE showed 98% less wear than did the same knee made using traditional implant materials. And when LEGION CR knee with the combination of our OXINIUM Technology and XLPE kept "walking" out to 45 million cycles, it was again ...
New Journey XR II Total Knee Replacement Implant
Tuesday, May 1, 2018. Bozeman, MT - Bridger Orthopedic has announced the addition of the highly anticipated, JOURNEY™ II XR Total Knee implant to its orthopedic offerings that use the CT-free, NAVIO™ Surgical System. Unlike traditional total knee implants, the JOURNEY II XR Total Knee Implant uses a specially designed U-shaped tibial base ...
JOURNEY II ROX
JOURNEY II TKA. The opening act for JOURNEY II ROX Solution has been shown to restore the anatomical shapes, position and motion of a normal knee;6-10providing improved clinical outcomes and higher patient satisfaction*10,18-22. Normal shapes: Featuring an anatomic, asymmetric femur/tibia,8,10,23 concave medial tibial surface8,9,23and a convex ...
JOURNEY II
The JOURNEY II BCS Knee . Recent advances in biomedical engineering software have opened a new chapter on high performance knee implants. One remarkable breakthrough has been the creation of the JOURNEY II BCS knee, a second-generation knee replacement that combines the stability and natural motion of the human knee with new low-friction materials that may extend the life of the implant.
The JOURNEY II BCS Knee
Recent advances in biomedical engineering software have opened a new chapter on high performance knee implants. One remarkable breakthrough has been the creation of the JOURNEY II BCS knee, a second-generation knee replacement that combines the stability and natural motion of the human knee with new low-friction materials that may extend the life of the implant.
JOURNEY II BCS Knee System Demonstrates Improved Patient Outcomes
The JOURNEY II BCS is a member of the JOURNEY II Total Knee Arthroplasty (TKA) system, which also includes JOURNEY II Cruciate Retaining (CR) and the recently launched bi-cruciate retaining JOURNEY II XR. ... Scott CE, Howie CR, MacDonald D, Biant LC; Predicting dissatisfaction following total knee replacement: a prospective study of 1217 ...
CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and
Background and rationale. Osteoarthritis of the knee is a common musculoskeletal condition. The surgical management of painful, end-stage osteoarthritis is by total knee replacement (TKR) which should be considered before there is prolonged and established functional limitation and severe pain [].Over 100,000 TKRs were performed in the UK in 2019 [].
Comparison of the Journey II bicruciate stabilised (JII-BCS) and
Objectives To determine if a newer design of total knee replacement (TKR) (Journey II BCS) produces superior patient-reported outcomes scores and biomechanical outcomes than the older, more established design (Genesis II). Setting Patients were recruited from an NHS University Hospital between July 2018 and October 2019 with surgery at two sites. Biomechanical and functional capacity ...
The Journey Bicruciate Knee Replacement: Design Modifications Yield
The Journey-I total knee replacement was designed to improve knee kinematics but had several complications including early dislocation. The Journey-II modification was introduced to reduce these while maintaining high function. To assess whether the modified Journey-II prosthesis has succeeded in its designers aims, we undertook an ...
JOURNEY II Total Knee Replacement
The JOURNEY II BCS Knee . Recent advances in biomedical engineering software have opened a new chapter on high performance knee implants. One remarkable breakthrough has been the creation of the JOURNEY II BCS knee, a second-generation knee replacement that combines the stability and natural motion of the human knee with new low-friction materials that may extend the life of the implant.
Knee Replacement Recovery: Timeline and Tips for Healing
Knee replacement surgery usually takes 1-2 hours to complete. However, it may take more or less time, depending on the complexity of the procedure, the surgeon's technique, and any additional treatments or repairs needed during surgery. How painful is a total knee replacement?
The JOURNEY DEUCE, an exciting new alternative to total knee replacement
Because of the new technology used in the JOURNEY DEUCE system, patients with knee arthritis isolated to just part of their knee-thought to be as many as 70% of knee replacement patients-now have an "early intervention" surgical option to end their debilitating pain. This minimally invasive partial knee replacement provides many potential benefits for patients,
CAPAbility: comparison of the JOURNEY II Bi-Cruciate ...
Osteoarthritis of the knee is a common condition that is expected to rise in the next two decades leading to an associated increase in total knee replacement (TKR) surgery. Although there is little debate regarding the safety and efficacy of modern TKR, up to 20% of patients report poor functional outcomes following surgery. This study will investigate the functional outcome of two TKRs; the ...

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The Procedure

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The Journey II Total Knee System: A Step Ahead – An Evolutionary New Design

The Journey II Total Knee Medial Pivot Design The “ Normal Feeling ” Knee Replacement

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The JOURNEY II BCS Knee

Implant Components

Bearing Surfaces

The Procedure

JOURNEY ◊ II Active Knee Solutions

Aren't all total knee implants the same?

How your knees move

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Data availability statement

Statistics from Altmetric.com

STRENGTHS AND LIMITATIONS OF THIS STUDY

Introduction

Trial design, randomisation, blinding to intervention allocation, ethics and registration

Sample size

Participants, setting and recruitment

Interventions

Experimental intervention

.Control intervention

Surgical techniques

Data collection schedule

Outcome measures

Secondary outcome measures

Walking and balance functional ability

Movement performance during walking and balance

Clinical context and adverse events

Supplemental material

Patient and public involvement

Flow of participants through the trial

Participant characteristics

Primary outcome comparison: 6 months postoperatively

Secondary outcome comparisons: 6 months postoperatively

Postoperative clinical context

Adverse events

Ethics statements