Multicenter Study on Clinical Outcomes of Unicondylar Knee Replacement Using U-Knee and Uni-Kroma Implants

What this Trial Is About

This clinical investigation is a post-market clinical follow-up study designed to collect short- and medium-term data on the performance of unicondylar knee prostheses, specifically the U-Knee and Uni-Kroma implants. The study aims to evaluate how these implants perform in patients with unicompartmental femoro-tibial osteoarthritis, a condition causing knee pain and reduced mobility when only one compartment of the knee joint is affected. Participants in this observational study have received one of several types of unicompartmental knee prostheses fixed cementless, fixed cemented, mobile cementless, mobile cemented, or fixed cementless with TIT coating. The study observes the clinical outcomes following the implantation of these devices without altering patient treatment. Participants will be monitored over a period extending up to 10 years, with assessments focusing on implant survival rate at 5 years as the primary outcome. Secondary outcomes include survival rates from 12-18 months up to 10 years, functional improvements from before surgery to 10 years, the degree to which patients forget about their prosthesis in daily life, and activity levels. Data collection involves postoperative follow-ups and questionnaires to evaluate these measures.

Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants