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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Eligibility

Primary outcome measure(s)

• Forgotten Joint Score (FJS-12) at 24 Months Postoperatively — 24 months postoperatively
  Patient-reported joint awareness and functional outcome assessed using the Forgotten Joint Score (FJS-12) questionnaire. The total score ranges from 0 to 100, where 0 represents the worst outcome (high joint awareness) and 100 represents the best possible outcome (complete forgetfulness of the artificial joint). Higher scores indicate better functional outcome and joint naturalness.

Trial sites (1)

More Groupe Hospitalier Diaconesses Croix Saint-Simon trials in France

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