Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants
Overview
- Phase
- Not Applicable
- Intervention
- Unicompartmental knee arthroplasty
- Conditions
- Unicompartmental Knee Arthroplasty
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Survival rate
- Status
- Recruiting
- Last Updated
- 10 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.
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 their questionnaires or perform postoperative follow-up
- •Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.
Arms & Interventions
Fixed cementless UKP
Patient implanted with a fixed cementless Unicompartmental prosthesis
Intervention: Unicompartmental knee arthroplasty
Fixed cemented UKP
Patient implanted with a fixed cemented Unicompartmental prosthesis
Intervention: Unicompartmental knee arthroplasty
Mobile Cementless UKP
Patient implanted with a mobile cementless Unicompartmental prosthesis
Intervention: Unicompartmental knee arthroplasty
Mobile Cemented UKP
Patient implanted with a mobile cemented Unicompartmental prosthesis
Intervention: Unicompartmental knee arthroplasty
Fixed Cementless UKP (TIT coating)
Patient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT"
Intervention: Unicompartmental knee arthroplasty
Outcomes
Primary Outcomes
Survival rate
Time Frame: 5 years
Assess the survival rate of the investigational medical devices at 5 year follow-up
Secondary Outcomes
- Functional improvement(From pre-operative to 10 years)
- Activity(From pre-operative to 10 years)
- Survival rate(12-18 months to 10 years)
- Forgetfulness of prosthesis(From pre-operative to 10 years)