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Clinical Trials in Germany / NCT06657248
Recruiting Observational

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

NCT06657248 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2026-04-02
Last updated
2026-05-08

Condition(s) studied

GonarthritisDegenerative Disease

Investigational drug(s) / intervention(s)

univation® XF Pro

univation® XF Pro: Primary medial unicompartmental knee arthroplasty

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Oberlinklinik gGmbH Potsdam Brandenburg Not Yet Recruiting
Lukas Krankenhaus Bünde North Rhine-Westphalia Not Yet Recruiting
St. Vincenz Hospital Brakel Brakel Germany Recruiting
LMU Großhadern München Germany Not Yet Recruiting

More Aesculap AG trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06657248 on ClinicalTrials.gov ↗ ← All trials in Germany