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Primary Total Knee ArthroplastyBCRNCT04855864

Journey Bicruciate Stabilized (BCS) Design and Legion Posterior Stabilized (PS) Design; Comparative Study

A study testing Follow-up of BCR TKA, Follow-up of BCS TKA and Follow-up of PS TKA in people with Primary Total Knee Arthroplasty, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Today, primary total knee arthroplasty (TKA) is considered to be a safe and successful therapy for end-stage osteoarthritis of the knee. In the past decades, different total knee prostheses have been released on the market showing minor or more important differences in design features. Read more about this study

Who is it for?
Ages 55 to 75 years
Conditions the study is for
Primary Total Knee Arthroplasty
What is being tested?
Follow-up of BCR TKA, Follow-up of BCS TKA and Follow-up of PS TKA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteBelgium
Study dates
8 Aug 2023to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ICF obtained
  • End stage bi- or tricompartmental osteoarthritis of the knee meeting the general criteria for TKA

Who cannot join

  • Inflammatory arthritis (e.g. rheumatoid arthritis).
  • BMI >30 due to less accurate gait analysis.
  • Extension deficit of >10° and flexion deficit of <110° of the knee.
  • Varus and valgus deviations >10° of the knee
  • Mental retardation, a systemic disease or decline normal health causing post-operative rehabilitation cannot take place properly.
  • Suggestive musculoskeletal deformity of the lower limb or vertebral column, causing postoperative rehabilitation cannot take place properly to prevent confounding. Normal joints are defined as asymptomatic joints with normal physical examination and mild to no changes on radiographs. An exception is made for primary total hip prosthesis.

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

Official title: Better Functional Outcome When Preserving, Substituting or Sacrificing ACL During TKA? A Prospective Functional Analysis of a Bicruciate Retaining, a Bicruciate Stabilized and a Posterior Stabilized Prosthetic Design

Today, primary total knee arthroplasty (TKA) is considered to be a safe and successful therapy for end-stage osteoarthritis of the knee. In the past decades, different total knee prostheses have been released on the market showing minor or more important differences in design features.

Smith and Nephew® (Memphis, Tennessee, USA) introduced a new posterior sacrificing (PS) design in 2005, which was called Journey BCS®, a bicruciate stabilizing design throughout knee flexion. This second generation guided motion total knee system prevents not only tibial posterior translation, but also limits tibial anterior translations by articulation between post and femoral box. As a consequence of the good results in the older population group, an increasing amount of younger and more active patients receiving TKA can be observed. In general, this age group scores remarkable lower in satisfaction. A possible explanation is the absence of anterior cruciate ligament (ACL) in these designs, which still causes abnormal kinematics. Therefore, in a further step, the research has been focusing on preserving both cruciate ligaments within the same basic design as Journey BCS®, keeping the curvature and contour of the femoral and tibial component, as well as the joint line principles. Consequently, a bi-cruciate retaining (BCR) design was developed, preserving both the ACL and posterior cruciate ligament (PCL) vessels.

BCR TKA of Smith \& Nephew, called Journey XR®, has a clear potential to result in a better functional outcome while avoiding the limitations and complications of previous other designs so that previously disappointing results of the pasts are not confirmed. As a result, patients are expected to be more capable to return to an active lifestyle with normal kinematics and proprioception of the knee. New insights in biomechanics, kinetics and proprioception in native knee and TKA make higher interest in BCR TKA inevitable. Yet, there is no prospective clinical trial available that compares Journey BCS® with Journey XR® from Smith \& Nephew in regard to PROMS, functional performance including gait analysis, survival and revision rates.

Read the detailed description

Today, primary total knee arthroplasty (TKA) is considered to be a safe and successful therapy for end-stage osteoarthritis of the knee. In the past decades, different total knee prostheses have been released on the market showing minor or more important differences in design features. As such, knee prostheses can differ in the level of constraint they provide. More specifically, for a few decades, two main designs were available for clinical use. First, designs that only sacrifice the anterior cruciate ligament (ACL), but retain the patient's own posterior cruciate ligament (PCL), the so-called cruciate retaining (CR) design, and secondly, designs that sacrifice the patient's ACL and PCL, the so-called posterior sacrificing (PS) design. The CR design has been considered historically as the least constrained design. The containment can be adjusted by equalizing the cavity and geometry of tibial end femoral surfaces. The PS knee design, known by the cam-post mechanism, offers more constrain, but sacrifices both cruciate ligaments. In terms of complications and outcome no difference can be found between PS and CR knee designs. However, the last decade, prosthetic research focused more and more on the preservation of both PCL and ACL, in an attempt to mimic better natural kinematic behaviour of the knee and to keep the proprioceptive function of the ACL and PCL vessels.

Smith and Nephew® (Memphis, Tennessee, USA) introduced a new PS design in 2005, which was called Journey BCS®, a bicruciate stabilizing design throughout knee flexion. This second generation guided motion total knee system prevents not only tibial posterior translation, but also limits tibial anterior translations by articulation between post and femoral box. The main purpose of this type of TKA was to achieve a more normal and natural kinematic behavior with more lateral posterior roll back, while keeping the medial side stable and preserving the normal natural joint line inclination. In particular, the medial femoral condyle is more distal than lateral condyle. There is a 3° varus joint line and the convex lateral tibial surface in sagittal plane creates a slight posterior slope. More anterior translation of the femur is seen with CR design during flexion allowing possibly little more flexion in BCS design. However, although the specific design properties of this prosthesis tended to mimic the stabilizing function of the natural cruciate ligaments much better, the patient's ACL is still sacrificed and at least its proprioceptive function is still completely lost. Mid-term results of Journey II BCS® are similar compared to other knee designs. However, the younger population group seems to end up with better scores when looking at postoperative clinical and functional results. As a consequence of the good results in the older population group, an increasing amount of younger and more active patients receiving TKA can be observed. Unfortunately, a significant part of these young patients keeps complaining of residual symptoms and pain in the knee after TKA. In general, this age group scores remarkable lower in satisfaction. A possible explanation is the absence of ACL in these designs, which still causes abnormal kinematics. Furthermore, the loss of its proprioceptive function might be a factor in the mentioned feeling of imperfection. Therefore, in a further step, the research has been focusing on preserving both cruciate ligaments within the same basic design as Journey BCS®, keeping the curvature and contour of the femoral and tibial component, as well as the joint line principles. Consequently, a bi-cruciate retaining (BCR) design was developed, preserving both the ACL and PCL vessels. Patients retain better knee kinematics, stability, proprioception and consequently better functionality and satisfaction by retaining ACL in TKA. Although the design is available on the American market for about seven years, and since 2 years also on the European market, it is still not widely used, even not by surgeons who are familiar with the other designs of the same prosthetic line. One of the reasons therefore might be the published higher rates of early revisions or poly exchange of another recent design in which both cruciate ligaments are preserved, released on the market by another prosthetic company a few years earlier.

BCR TKA of Smith \& Nephew, called Journey XR®, is designed to retain both cruciate ligaments. Journey XR® design has a clear potential to result in a better functional outcome while avoiding the limitations and complications of previous other designs so that previously disappointing results of the pasts are not confirmed. As a result, patients are expected to be more capable to return to an active lifestyle with normal kinematics and proprioception of the knee. Journey XR® preserves specific features of Journey BCS®, such as asymmetric femoral condyles, 3° varus joint line and low constraint concave medial and convex lateral articular surface. In order to preserve both cruciate ligaments Journey XR® design has some adjustments, which are mentioned here. Tibial base plate design with continuous keel and anterior bridge, consists of high-quality forged Ti-6Al-4V which is less stiff. These tibial component updates were implemented to reduce the risk of bone resorption from stress shielding and to double fatigue strength compared to BCR design of another company. Fixation of tibial Journey XR® baseplate, which is provided with an asymmetrical notch to accept ACL footprint, is based on four-corner peg fixation with maximal bone coverage and good results compared to known knee designs with stem fixation. Furthermore, tibial insert lock is optimized. Previous total knee designs of Smith and Nephew® already proved very limited poly wear when using highly cross-linked polyethylene (XLPE) in combination with OXINIUM, according to VERILAST® technology. Approximately 4000 Journey XR® procedures have been done globally in the last 3 years in 10 countries, among which US, Japan, South Africa and some countries in Western EU like Belgium. Currently 21% of these cases is placed using NAVIO® or Cori robot technology but this proportion is growing. Present literature is clear that retention of ACL and PCL has significant higher satisfaction compared to TKA patients, as with partial knee arthroplasty. Moreover, last update of journey XR® design of 2017 had interesting solutions for the limitations of the mentioned previous design. Problems like tibia poly wear, tibia insert lock and implant strength were common. New insights in biomechanics, kinetics and proprioception in native knee and TKA make higher interest in BCR TKA inevitable. Yet, there is no prospective clinical trial available that compares Journey BCS® with Journey XR® and the Legion PS® design from Smith \& Nephew in regard to PROMS, functional performance including gait analysis, survival and revision rates.

Being tested
Follow-up of BCR TKA, Follow-up of BCS TKA, Follow-up of PS TKA
Keywords
Journey BCS®, Journey XR®, Legion PS®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follow-up of BCR TKAOther

    Also called Journey XR®

    Pre- and postoperative follow-up of patients treated with the BCR design by measuring PROMs, and clinical- and radiographic evaluation

  • Follow-up of BCS TKAOther

    Also called Journey BCS®

    Pre- and postoperative follow-up of patients treated with the BCS design by measuring PROMs, and clinical- and radiographic evaluation

  • Follow-up of PS TKAOther

    Also called Legion PS®

    Pre- and postoperative follow-up of patients treated with the PS design by measuring PROMs, and clinical- and radiographic evaluation

Study groups in NCT04855864
Study groupRoleWhat they receive
BCR TKAOtherPatients with intact and functional ACL and PCL will be treated with the BCR design
Receives: Other: Follow-up of BCR TKA
BCS TKAOtherPatients with an afunctional or absent ACL and/or PCL will be treated with the BCS design
Receives: Other: Follow-up of BCS TKA
PS TKAOtherPatients with an afunctional or absent ACL and/or PCL will be treated with the PS design
Receives: Other: Follow-up of PS TKA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxford Knee Score (OKS)

    To assess function and pain after total knee arthroplasty

    Measured: Within a period of 2 years

  2. EuroQol 5D-5L (EQ5D-5L)

    To evaluate mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

    Measured: Within a period of 2 years

  3. Visual Analogue Scale (VAS)

    To measure acute and chronic pain

    Measured: Within a period of 2 years

  4. Knee Range of Motion (ROM)

    To measure knee extension/flexion using a goniometer

    Measured: Within a period of 2 years

  5. Knee Society Score (KSS)

    To provide a simple and objective scoring system to rate the knee and patient's functional abilities before and after total knee arthroplasty.

    Measured: Within a period of 2 years

  6. Forgotten Joint Score (FJS)

    To assess how natural the prosthesis feels after total knee arthroplasty

    Measured: Within a period of 2 years

  7. Radiographic evaluation

    To perform a standard knee radiography using X-ray (face in extension, profile max flexion, axial 30° flexion) and CT-scan for measuring the knee alignment

    Measured: Within a period of 2 years

  8. Knee joint function during gait

    To assess knee joint function through instrumented motion analysis during gait

    Measured: Within a period of 2 years

  9. Knee joint function during motor tasks

    To assess knee joint function through instrumented motion analysis during motor tasks (walking up and down hill and stairs,...)

    Measured: Within a period of 2 years

  10. EOS full-leg radiography

    To perform a full-leg radiography for measuring the knee alignment

    Measured: Within a period of 2 years

Secondary outcomes (1)
  1. Motion analysis

    Patients are compared to a matched control group with a healthy natural knee, available in a database.

    Measured: Within a period of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start8 Aug 2023
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04855864
Sponsor's protocol ID
S64561
Acronym
BCR
Status last verified
Mar 2026
First submitted
16 Apr 2021
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Follow-up of BCR TKA, Follow-up of BCS TKA and Follow-up of PS TKA in people with Primary Total Knee Arthroplasty, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxford Knee Score (OKS) (time frame: Within a period of 2 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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