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

Recruitingn/aAges 18 Years - 75 YearsAllAesculap AG
NCT06657248 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy * Patient age \<18 and \> 75 years * BMI ≥ 40 * High risk patients ASA \> III
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What it tests

  • univation® XF Pro
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Where

4 sites
Lukas Krankenhaus
Bünde, Germany
St. Vincenz Hospital Brakel
Brakel, Germany
LMU Großhadern
München, Germany
Sportklinik Ravensburg
Ravensburg, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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