Clinical Trial

Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach

Study acronym: CR-PS
Active, Not Recruiting
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Summary
Background and Rationale: Conventional mechanical implantation of total knee arthroplasty (TKA) aims to establish a lower-limb mechanical axis of 180°. Computer-assisted personalized implantation aims to restore a pre-arthritic alignment while respecting the soft-tissue envelope of the knee. Depending on design, TKA implants may either retain or sacrifice the posterior cruciate ligament (PCL). In mechanically implanted TKAs, functional outcomes of cruciate-retaining (CR) and posterior-stabilized (PS) designs are reported as comparable in the literature. However, these two designs have not been compared within a computer-assisted personalized implantation workflow. Objective and Hypothesis: The objective of this randomized comparative study is to compare functional outcomes (patient-reported outcome measures - PROMs) at 24 months postoperatively following CR versus PS knee arthroplasty implanted with a personalized technique. The hypothesis is that there is no significant difference in functional outcomes between CR and PS prostheses implanted using a personalized technique. Study Design: Single-center, open-label, randomized, two-arm parallel-group trial comparing a group of patients receiving a cruciate-retaining (CR) total knee prosthesis to a group receiving a posterior-stabilized (PS) total knee prosthesis.
Trial Details
NCT Number NCT07757581
Lead Sponsor Groupe Hospitalier Diaconesses Croix Saint-Simon
Conditions Knee Arthroplasty, Osteoarthritis, Knee
Enrollment 140 participants
Start Date 2024-03-07
Primary Completion 2026-10-02 (estimated)
Study Completion 2027-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-11