Clinical Performance and Safety of the Unicompartmental Univation® XF Pro Implant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAesculap AG
About this trial
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 criteria
Qualifiers
Indication for a primary medial unicompartmental knee endoprosthesis
Both cruciate ligaments intact
Lateral ligaments intact
Leg axis amenable to passive correction
Disqualifiers
Pregnancy
Patient age <18 and > 75 years
BMI ≥ 40
High risk patients ASA > III
Trial design
Treatments tested in this trial
- univation® XF Pro
Treatment groups
150 Participants
are divided into 1 treatment groupLocations
4Oberlinklinik gGmbH14482, PotsdamBrandenburg, Germany
Lukas Krankenhaus32257, BündeNorth Rhine-Westphalia, Germany
St. Vincenz Hospital Brakel33034, Brakel Germany
LMU Großhadern81377, München Germany
Sponsors and collaborators
Aesculap AG
Lead sponsor
Raylytic GmbH
Collaborator
Source ClinicalTrials.gov