NCT05876143

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Societe dEtude, de Recherche et de Fabrication · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2030-01-31
• Completion: 2035-01-31
• First posted: 2023-05-25
• Last updated: 2024-07-12

Locations

1 site across 1 country: France