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

NCT05876143 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-04-22

No results posted yet for this 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.

Conditions

  • Unicompartmental Knee Arthroplasty

Interventions

DEVICE

Unicompartmental knee arthroplasty

Knee joint could be subject to natural or pathological wear or shocks (primary or secondary evolutive or traumatic osteoarthritis) which cause pain and reduced mobility of the knee. When only one lateral or medial compartment of the femoro-tibial knee joint is affected, the treatment of unicompartmental femoro-tibial osteoarthritis of the knee is generally carried out by the implantation of a so-called unicondylar knee prosthesis (UKP), in order to reduce pain and improve joint mobility of the knee compared to the preoperative state.

Sponsors & Collaborators

  • Societe dEtude, de Recherche et de Fabrication

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2030-01-31
Completion
2035-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05876143 on ClinicalTrials.gov