Ambispective Multicentric Study Evaluating UKA With U-Knee/Uni-Kroma Implants

Last updated: July 11, 2024
Sponsor: Societe dEtude, de Recherche et de Fabrication
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Replacement

Treatment

Unicompartmental knee arthroplasty

Clinical Study ID

NCT05876143
2022-01
  • Ages > 18
  • All Genders

Study Summary

This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage).The main objective of this study is to collect short- and medium-term clinical data on the unicondylar knee prosthesis U-Knee / Uni-Kroma, in order to evaluate the performance of these implants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis andbenefiting from the social security affiliation scheme.

Exclusion

Exclusion Criteria:

  • Patients who objected to participating in the study and the processing of their data

  • Patients unable to understand the surgeon's instructions to complete theirquestionnaires or perform postoperative follow-up

  • Patients who already have a unicompartmental prosthesis on the knee in question thatneed to be revised.

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: Unicompartmental knee arthroplasty
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
January 31, 2035

Connect with a study center

  • CHU Lyon Sud

    Pierre-Bénite,
    France

    Active - Recruiting

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