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

NCT07849959 | Completed

• 1 other identifier: 11/06/2026-27262
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis (OA) of the Knee

Keywords

total knee arthroplasty; pcl retention; pcl sacrifice; medial pivot prosthesis

Outcome Measures

Primary Outcomes (1)

• Forgotten Joint Score-12 (FJS-12) at 24 Months After Total Knee Arthroplasty

  24 months after total knee arthroplasty

Secondary Outcomes (3)

• Knee Society Score (KSS) at 24 Months After Total Knee Arthroplasty

  24 months after total knee arthroplasty

• Oxford Knee Score (OKS) at 24 Months After Total Knee Arthroplasty

  24 months after total knee arthroplasty

• Change From Baseline in Knee Range of Motion at 24 Months After Total Knee Arthroplasty

  Baseline and 24 months after total knee arthroplasty

Study Arms (2)

PCL retention

EXPERIMENTAL

Participants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis with retention of the posterior cruciate ligament (PCL).

Procedure: PCL Retention During Medial Pivot Total Knee Arthroplasty

PCL sacrifice

ACTIVE COMPARATOR

Participants randomized to this arm will undergo primary total knee arthroplasty using the same medial-pivot knee prosthesis, with sacrifice (removal) of the posterior cruciate ligament (PCL).

Procedure: PCL Sacrifice During Medial Pivot Total Knee Arthroplasty

Interventions

PCL Retention During Medial Pivot Total Knee Arthroplasty PROCEDURE

Participants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis (MicroPort Evolution) with retention of the posterior cruciate ligament (PCL). The procedure will be performed according to the standardized surgical technique used by the Orthopaedic Department.

PCL retention

PCL Sacrifice During Medial Pivot Total Knee Arthroplasty PROCEDURE

Participants randomized to this arm will undergo primary total knee arthroplasty using a medial-pivot knee prosthesis (MicroPort Evolution) with sacrifice of the posterior cruciate ligament (PCL). The procedure will be performed according to the standardized surgical technique used by the Orthopaedic Department.

PCL sacrifice

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous surgery on the affected knee. Inflammatory arthritis. Active infection. Severe lower-limb deformity greater than 15 degrees. Neurological disease affecting lower-limb function.

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

University Hospital of Larissa

Larissa, Thessaly, 41500, Greece

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD(c)

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2023
• Primary Completion: September 1, 2026
• Study Completion: September 24, 2026
• Last Updated: September 30, 2026

Record last verified: 2026-09

Locations

GR (1)