Trials / Not Yet Recruiting
Not Yet RecruitingNCT06657248
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Aesculap AG · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- —
Summary
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.
Detailed description
The product under investigation is used in routine clinical practice and according to the authorized Instructions for Use (IfU). The data that is obtained in routine clinical use will be documented in an electronical Case Report Form (eCRF). The study's main purpose is the collection of clinical data on the safety and performance of the redesigned univation® XF Pro implant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | univation® XF Pro | Primary medial unicompartmental knee arthroplasty |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-10-01
- Completion
- 2032-10-01
- First posted
- 2024-10-24
- Last updated
- 2026-02-27
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT06657248. Inclusion in this directory is not an endorsement.