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

Study Research and Manufacturing Company (SERF)

Status: Enrolling

Conditions: Unicompartmental Knee Arthroplasty

Treatments: Device: Unicompartmental knee arthroplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT05876143

2022-01

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 5 patient groups

Fixed cementless UKP

Description:

Patient implanted with a fixed cementless Unicompartmental prosthesis

Treatment:

Device: Unicompartmental knee arthroplasty

Fixed cemented UKP

Description:

Patient implanted with a fixed cemented Unicompartmental prosthesis

Treatment:

Device: Unicompartmental knee arthroplasty

Mobile Cementless UKP

Description:

Patient implanted with a mobile cementless Unicompartmental prosthesis

Treatment:

Device: Unicompartmental knee arthroplasty

Mobile Cemented UKP

Description:

Patient implanted with a mobile cemented Unicompartmental prosthesis

Treatment:

Device: Unicompartmental knee arthroplasty

Fixed Cementless UKP (TIT coating)

Description:

Patient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT"

Treatment:

Device: Unicompartmental knee arthroplasty