Comparing two knee prosthesis designs for total knee replacement
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
NA · Universitaire Ziekenhuizen KU Leuven · NCT04855864
This study is testing two different knee replacement designs to see which one helps patients with severe osteoarthritis feel better and be more active after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT04855864 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two different designs of knee prostheses used in primary total knee arthroplasty (TKA) for patients with end-stage osteoarthritis. The Journey Bicruciate Stabilized (BCS) design aims to preserve natural knee kinematics by maintaining both cruciate ligaments, while the Legion Posterior Stabilized (PS) design sacrifices both ligaments for increased constraint. The study will follow patients receiving these prostheses to evaluate their outcomes and satisfaction levels. The goal is to determine which design provides better functional results and patient satisfaction, particularly for younger and more active individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with end-stage bi- or tricompartmental osteoarthritis of the knee who meet the criteria for total knee arthroplasty.
Not a fit: Patients with inflammatory arthritis, significant knee deformities, or those unable to participate in post-operative rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved knee function and satisfaction for patients undergoing total knee arthroplasty.
How similar studies have performed: Previous studies have shown varying success with different knee prosthesis designs, but this specific comparison of the BCS and PS designs is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ICF obtained * End stage bi- or tricompartmental osteoarthritis of the knee meeting the general criteria for TKA Exclusion Criteria: * 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.
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
Study contacts
- Principal investigator: Hilde Vandenneucker — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Hilde Vandenneucker
- Email: hilde.vandenneucker@uzleuven.be
- Phone: +32 16 33 88 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Total Knee Arthroplasty, Journey BCS®, Journey XR®, Legion PS®