A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Medacta International SA
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Comparing the occurrence of radiolucency's lines
- Status
- Active, Not Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee. The current comparative randomized study aims to evaluate the fixation of cemented and cementless designs of GMK-UNI unicompartmental knee prosthesis over a 5-year time period.
Detailed Description
The Primary objective is to compare the quality of fixation of cemented and cementless designs of GMK-UNI unicompartmental knee replacement at 2 years of follow-up. The Secondary objectives include the evaluation of the patient improvement (subjective and objective) using the new Knee Society Score (KSS); the patient's anterior pain following UKA and any eventual patella-femoral disorder; Implant survival rate using the Kaplan Meier analysis; Post-op radiological findings and Adverse Events. The Primary outcome aims to compare the occurrence of radiolucency's lines (both partial and complete) between the two study groups. Secondary outcomes include New KSS, OKS, Kaplan Meier analysis and stability and fixation of UNI prosthesis. All patients who meet the inclusion criteria to take part in the current clinical study will be invited to participate before the surgery. Subjects will be randomized during the screening; half of them will receive the cemented GMK-UNI anatomical UKA and the other half the cementless GMK-UNI anatomical UKA. Clinical data will be recorded on CRF at those time-points: * Before the surgery * During the surgery * After the surgery at 3 months, 1, 2, 3 and 5 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Comparing the occurrence of radiolucency's lines
Time Frame: 5 yrs
Compare occurrence of radiolucency's lines (both partial and complete)between the two study groups
Secondary Outcomes
- Anterior Knee Pian Scale (Kujala score)(pre-op; 3months;1,2,3,5 yrs)
- Recording of adverse events(Throughout the study)
- New Knee Society Score(Pre-op:3months;1,2,3,5 yrs)
- Implant survival rate using Kaplan Meier analysis(5 yrs)
- Oxford Knee Score(Pre-op;3month;1,2,3,5yrs)
- Stability and fixation of unicompartmental prosthesis(5 yrs)