NCT03522025

GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs

A Prospective, Multicenter, Randomised Study to Evaluate the Fixation of Cemented and Cementless Design of GMK-UNI Anatomical Knee Prosthesis.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Medacta International SA · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	Unicompartmental Knee Arthroplasty (UKA)	Unicompartmental Knee Arthroplasty (UKA) is a less invasive treatment option compared to Total Knee Arthroplasty (TKA) for patients with primary anteromedial knee osteoarthritis.

Timeline

• Start date: 2019-02-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2018-05-11
• Last updated: 2025-09-25

Locations

5 sites across 2 countries: France, Switzerland