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Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach
Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2024-03-07
Completion Date
2027-01-30
Last Updated
2026-08-11
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, France