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Completed NCT07849959

PCL Retention Versus Sacrifice During Total Knee Replacement With a Medial Pivot Prosthesis

Conditions: Osteoarthritis (OA) of the Knee

Sex: All
Ages: 50 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: University of Thessaly

Location: University Hospital of Larissa Larissa Thessaly

Summary

otal knee replacement is a common treatment for patients with severe knee osteoarthritis when non-surgical treatments no longer provide adequate relief. During total knee replacement, surgeons may either preserve or remove the posterior cruciate ligament (PCL), a ligament located inside the knee. Both approaches are used in clinical practice, but the effect of PCL preservation or removal when using a medial-pivot knee prosthesis is not fully established. This study will compare two surgical approaches in patients undergoing total knee replacement with the same medial-pivot prosthesis. Participants will be randomly assigned to either PCL retention or PCL sacrifice during surgery. The main purpose of the study is to determine whether retaining or removing the PCL affects how patients perceive and function with their artificial knee. The primary outcome will be the Forgotten Joint Score-12 (FJS-12) at 24 months after surgery, which assesses how much patients are aware of their artificial knee during everyday activities. Other outcomes will include knee function, pain, range of motion, stability, patient satisfaction, complications, and radiographic findings. The study hypothesis is that there may be a difference in patient-reported outcomes between PCL retention and PCL sacrifice when a medial-pivot knee prosthesis is used. Participants will be evaluated before surgery and at 3, 6, 12, and 24 months after surgery.

Eligibility Criteria

Inclusion Criteria: Age 50 to 85 years. Symptomatic end-stage osteoarthritis of the knee, confirmed clinically and radiographically. Failure of conservative treatment for knee osteoarthritis. Suitable candidate for primary total knee arthroplasty. Able to participate in and complete the planned postoperative follow-up schedule Exclusion Criteria: Previous surgery on the affected knee. Inflammatory arthritis. Active infection. Severe lower-limb deformity greater than 15 degrees. Neurological disease affecting lower-limb function.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07849959). StuddyBuddy aggregates publicly available trial information.