Observational Study on Safety and Midterm Performance of the Unicompartmental Univation XF Pro Knee Implant in Patients with Gonarthritis

What this Trial Is About

This research aims to evaluate the midterm clinical performance and safety of the redesigned univationae XF Pro knee implant used in primary medial unicompartmental knee arthroplasty. The study is observational, prospective, and multi-center, including 150 patients across four centers in Germany. It focuses on collecting clinical data during routine use of the implant according to its authorized Instructions for Use. Participants will receive the univationae XF Pro implant as part of their knee arthroplasty treatment. Data collection will occur at multiple time points including discharge 7-10 days post-op, 3 months, 1 year, 2 years, and 5 years postoperatively. The study documents implant performance, safety, and patient-reported outcomes without altering standard care. During the study, participants will undergo various assessments including patient-reported functional outcomes, implant survival analysis, quality of life questionnaires, clinical outcome progress, and radiological evaluations such as long leg x-rays and patella imaging. Adverse events and radiological complications will be monitored throughout the 5-year follow-up period. The total participation duration extends up to five years after surgery.

Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant