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NCT06657248 | NOT YET RECRUITING | Gonarthritis

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

Aesculap AG

Brief 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. 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.

Condition or disease

Gonarthritis

Degenerative Disease

Intervention/treatment

univation® XF Pro

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
Official Title : Prospective, Multicenter Study Evaluating the Midterm Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Knee Implant
Actual Study Start Date : 2025-11
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2031-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
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
Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant

Location Details

NCT06657248

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany, Brandenburg

Oberlinklinik gGmbH

Potsdam, Brandenburg, Germany, 14482

Not yet recruiting

Germany, North Rhine-Westphalia

Lukas hospital

Fründe, North Rhine-Westphalia, Germany, 32257

Not yet recruiting

Germany,

St. Vincenz Hospital Brakel

Brackle, Germany, 33034

Not yet recruiting

Germany,

LMU Großhadern

München, Germany, 81377