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

NCT04855864 | Active Not Recruiting

• 1 other identifier: S64561
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Journey BCS®; Journey XR®; Legion PS®

Outcome Measures

Primary Outcomes (10)

• Oxford Knee Score (OKS)

  To assess function and pain after total knee arthroplasty

  Within a period of 2 years

• EuroQol 5D-5L (EQ5D-5L)

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

  Within a period of 2 years

• Visual Analogue Scale (VAS)

  To measure acute and chronic pain

  Within a period of 2 years

• Knee Range of Motion (ROM)

  To measure knee extension/flexion using a goniometer

  Within a period of 2 years

• 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.

  Within a period of 2 years

• Forgotten Joint Score (FJS)

  To assess how natural the prosthesis feels after total knee arthroplasty

  Within a period of 2 years

• 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

  Within a period of 2 years

• Knee joint function during gait

  To assess knee joint function through instrumented motion analysis during gait

  Within a period of 2 years

• 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,...)

  Within a period of 2 years

• EOS full-leg radiography

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

  Within a period of 2 years

Secondary Outcomes (1)

• Motion analysis

  Within a period of 2 years

Study Arms (3)

BCR TKA

OTHER

Patients with intact and functional ACL and PCL will be treated with the BCR design

Other: Follow-up of BCR TKA

BCS TKA

OTHER

Patients with an afunctional or absent ACL and/or PCL will be treated with the BCS design

Other: Follow-up of BCS TKA

PS TKA

OTHER

Patients with an afunctional or absent ACL and/or PCL will be treated with the PS design

Other: Follow-up of PS TKA

Interventions

Follow-up of BCR TKA OTHER

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

Also known as: Journey XR®

BCR TKA

Follow-up of BCS TKA OTHER

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

Also known as: Journey BCS®

BCS TKA

Follow-up of PS TKA OTHER

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

Also known as: Legion PS®

PS TKA

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Study Officials

• Hilde Vandenneucker

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 22, 2021
• Study Start: August 8, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)