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ACTIVE NOT RECRUITING
NCT04855864
NA

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

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

55 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2023-08-08

Completion Date

2027-01

Last Updated

2026-03-13

Healthy Volunteers

No

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

Locations (1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium