Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06657248

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

Led by Aesculap AG · Updated on 2026-05-08

150

Participants Needed

4

Research Sites

339 weeks

Total Duration

On this page

Sponsors

A

Aesculap AG

Lead Sponsor

R

Raylytic GmbH

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Indication for a primary medial unicompartmental knee endoprosthesis
  • 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
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Patient age <18 and >75 years
  • BMI ≥ 40
  • High risk patients ASA > III

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Oberlinklinik gGmbH

Potsdam, Brandenburg, Germany, 14482

Not Yet Recruiting

2

Lukas Krankenhaus

Bünde, North Rhine-Westphalia, Germany, 32257

Not Yet Recruiting

3

St. Vincenz Hospital Brakel

Brakel, Germany, 33034

Actively Recruiting

4

LMU Großhadern

München, Germany, 81377

Not Yet Recruiting

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Research Team

P

Petra Wain

CONTACT

S

Stefan Maenz, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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