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

Recruiting

• Conditions: Unicompartmental Knee Arthroplasty
• Interventions: Device: Unicompartmental knee arthroplasty

• Registration Number: NCT05876143
• Lead Sponsor: Societe dEtude, de Recherche et de Fabrication

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-05-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2030-01-31
• Study Completion: 2035-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fixed cemented UKP	Unicompartmental knee arthroplasty	Patient implanted with a fixed cemented Unicompartmental prosthesis
Fixed cementless UKP	Unicompartmental knee arthroplasty	Patient implanted with a fixed cementless Unicompartmental prosthesis
Mobile Cementless UKP	Unicompartmental knee arthroplasty	Patient implanted with a mobile cementless Unicompartmental prosthesis
Mobile Cemented UKP	Unicompartmental knee arthroplasty	Patient implanted with a mobile cemented Unicompartmental prosthesis
Fixed Cementless UKP (TIT coating)	Unicompartmental knee arthroplasty	Patient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT"

Primary Outcome Measures

Name	Time	Method
Survival rate	5 years	Assess the survival rate of the investigational medical devices at 5 year follow-up

Secondary Outcome Measures

Name	Time	Method
Functional improvement	From pre-operative to 10 years	Evaluate pain, symptoms, activities of daily life and sports activity using KOOS score
Activity	From pre-operative to 10 years	Evaluate the degree of activity using Devane score
Survival rate	12-18 months to 10 years	Assess the survival rate of the investigational medical devices at 12-18 months, 3 years and 10 years follow-up
Forgetfulness of prosthesis	From pre-operative to 10 years	Evaluate the degree of forgetfulness of the prostheses using FJS- score

Trial Locations

Locations (1)

CHU Lyon Sud; 🇫🇷 Pierre-Bénite, France