Performance and safety of the Univation XF Pro partial knee implant
Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 4 sites (Potsdam, Brandenburg and 3 other locations) |
| Trial ID | NCT06657248 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Potsdam, Brandenburg and 3 other locations
- Oberlinklinik gGmbH — Potsdam, Brandenburg, Germany (Not_yet_recruiting)
- Lukas Krankenhaus — Bünde, North Rhine-Westphalia, Germany (Not_yet_recruiting)
- St. Vincenz Hospital Brakel — Brakel, Germany (Recruiting)
- LMU Großhadern — München, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Rolf Haaker, Prof. Dr. — St. Vincenz Hospital Brakel
- Study coordinator: Petra Wain
- Email: info@aesculap.de
- Phone: +49746195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.