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

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.

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.

Conditions

• Primary Total Knee Arthroplasty

Interventions

OTHER

Follow-up of BCR TKA

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

OTHER

Follow-up of BCS TKA

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

OTHER

Follow-up of PS TKA

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Hilde Vandenneucker · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-08

Primary Completion

2027-01-31

Completion

2027-01-31

Countries

• Belgium

Study Locations