Performance and safety of the Univation XF Pro partial knee implant
Official title: Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
Run by Aesculap AG · NCT06657248 · Data updated 2026-11-12
This study will follow people receiving a medial partial knee replacement with the Univation XF Pro implant to see how well it works and how safe it is.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 4 sites (Bünde, North Rhine-Westphalia and 3 other locations) |
| Status | Recruiting |
| Started | April 2, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2032 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT06657248 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with isolated medial degenerative knee disease who are indicated for a primary medial unicompartmental knee replacement and meet the implant IFU (intact cruciate and lateral ligaments, passively correctable leg axis, varus deformity under 15°, sufficient range of motion, and able to give informed consent) are ideal candidates.
✕Probably not a fit
Patients who are pregnant, younger than 18 or older than 75, have BMI ≥ 40, are high surgical risk (ASA > III), have significant lateral compartment disease or gross instability, or otherwise fall outside the implant IFU are unlikely to benefit from this enrollment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, observational, mid-term, multicenter follow-up enrolling about 150 patients across four centers in Germany. The Univation XF Pro implant is used in routine clinical practice according to the authorized Instructions for Use, and patients are treated as part of standard care. Clinical data from those procedures and follow-up visits will be recorded in an electronic case report form (eCRF). The main goal is to collect real-world clinical data on the safety and performance of the redesigned Univation XF Pro unicompartmental implant.
Why it matters
Potential benefit: If results are favorable, the data could support that the redesigned implant provides reliable pain relief and improved knee function with a low rate of complications for patients with isolated medial knee osteoarthritis.
How similar studies have gone: Partial (unicompartmental) knee replacements have demonstrated good outcomes in many prior studies, but published mid-term data specific to the redesigned Univation XF Pro implant are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Lukas Krankenhaus
Bünde, North Rhine-Westphalia, Germany Recruiting -
LMU Großhadern
München, Germany Recruiting -
Sportklinik Ravensburg
Ravensburg, Germany Recruiting -
St. Vincenz Hospital Brakel
Brakel, Germany Withdrawn
Study contacts
- Principal investigator: Rolf Haaker, Prof. Dr. — St. Vincenz Hospital Brakel
- Study coordinator: Petra Wain
- Email: info@aesculap.de
- Phone: +49746195
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.