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
Sponsor
Aesculap AG
Enrollment
150 participants
Start Date
Apr 2, 2026
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria12
- 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 Criteria4
- Pregnancy
- Patient age <18 and > 75 years
- BMI ≥ 40
- High risk patients ASA > III
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Interventions
DEVICEunivation® XF Pro
Primary medial unicompartmental knee arthroplasty
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06657248