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

Recruiting now

Conditions studied: Gonarthritis, Degenerative Disease

In brief

The study is designed as a prospective, observational, mid-term, multi-center follow-up study. It is planned to include 150 patients from 4 different study centres in Germany.

Key facts

Study ID

NCT06657248

Run by

Aesculap AG

People needed

150

Starts

2026-04-02

Expected to finish

2032-10-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Indication for a primary medial unicompartmental knee endoprosthesis
• Acc. to Instructions for Use:
• Both cruciate ligaments intact
• Lateral ligaments intact
• Leg axis amenable to passive correction
• Varus deformity under 15°
• Bending capability of at least 90°
• Extension deficit no greater than 5-10°
• Written informed consent of patient
• Kellgran \& Lawrence Score > II (only straight or varus
• Patients with moderate radiological symptoms
• Patients without clinical symptoms

You may not qualify if…

• Pregnancy
• Patient age <18 and > 75 years
• BMI ≥ 40
• High risk patients ASA > III

Where it is running

• St. Vincenz Hospital Brakel — Brakel, Germany (enrolling)
• Oberlinklinik gGmbH — Potsdam, Brandenburg, Germany
• Lukas Krankenhaus — Bünde, North Rhine-Westphalia, Germany
• LMU Großhadern — München, Germany

Full record on ClinicalTrials.gov

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