RecruitingNCT05876143

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

Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants


Sponsor

Societe dEtude, de Recherche et de Fabrication

Enrollment

400 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria3

  • Patients who objected to participating in the study and the processing of their data
  • Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up
  • Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.

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Interventions

DEVICEUnicompartmental 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.


Locations(1)

CHU Lyon Sud

Pierre-Bénite, France

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NCT05876143