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

NCT ID: NCT05876143

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2035-01-31

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.

Conditions

Unicompartmental Knee Arthroplasty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Fixed cementless UKP

Patient implanted with a fixed cementless Unicompartmental prosthesis

Unicompartmental knee arthroplasty

Intervention Type: DEVICE

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.

Fixed cemented UKP

Patient implanted with a fixed cemented Unicompartmental prosthesis

Unicompartmental knee arthroplasty

Intervention Type: DEVICE

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.

Mobile Cementless UKP

Patient implanted with a mobile cementless Unicompartmental prosthesis

Unicompartmental knee arthroplasty

Intervention Type: DEVICE

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.

Mobile Cemented UKP

Patient implanted with a mobile cemented Unicompartmental prosthesis

Unicompartmental knee arthroplasty

Intervention Type: DEVICE

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.

Fixed Cementless UKP (TIT coating)

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

Unicompartmental knee arthroplasty

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Societe dEtude, de Recherche et de Fabrication

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Lyon Sud

Pierre-Bénite, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Clinical Department

Role: CONTACT

clinical@serf.fr

0472056010 ext. +33

Facility Contacts

Anthony Viste

Role: primary

Other Identifiers

2022-01

Identifier Type: -

Identifier Source: org_study_id