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

NCT07757581 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

  • Knee Arthroplasty
  • Osteoarthritis, Knee

Interventions

PROCEDURE

Implantation surgery for CR and PS knee-joint prostheses used in the orthopedic surgery department's routine practice

The approach, the need for posterior cruciate ligament or collateral ligament release, the need to change from a CR to a PS prosthesis and the duration of the procedure will be recorded on the data collection sheet with the implantation and measurement characteristics performed with the navigator: * HKA and initial and final flessums * Tibial cuts: thickness (max), slope, obliquity of cut * Femoral sections: distal and posterior thickness (max), mechanical femoral angle, rotation, femoral flessum, obliquity of cut. * Thickness of implanted polyethylene

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Principal Investigators

  • Simon MARMOR, Orthopedic surgeon · Groupe Hospitalier Diaconesses Croix Saint-Simon

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2026-10-02
Completion
2027-01-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757581 on ClinicalTrials.gov