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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Primary outcome measure(s)

• Survival rate — 5 years
  Assess the survival rate of the investigational medical devices at 5 year follow-up

Trial sites (1)

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