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

NCT05876143 | Recruiting

• 1 other identifier: 2022-01
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Survival rate

  Assess the survival rate of the investigational medical devices at 5 year follow-up

  5 years

Secondary Outcomes (5)

• Survival rate

  12-18 months to 10 years

• Functional improvement

  From pre-operative to 10 years

• Functional improvement

  From pre-operative to 10 years

• Forgetfulness of prosthesis

  From pre-operative to 10 years

• Activity

  From pre-operative to 10 years

Study Arms (5)

Fixed cementless UKP

Patient implanted with a fixed cementless Unicompartmental prosthesis

Device: Unicompartmental knee arthroplasty

Fixed cemented UKP

Patient implanted with a fixed cemented Unicompartmental prosthesis

Device: Unicompartmental knee arthroplasty

Mobile Cementless UKP

Patient implanted with a mobile cementless Unicompartmental prosthesis

Device: Unicompartmental knee arthroplasty

Mobile Cemented UKP

Patient implanted with a mobile cemented Unicompartmental prosthesis

Device: Unicompartmental knee arthroplasty

Fixed Cementless UKP (TIT coating)

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

Device: Unicompartmental knee arthroplasty

Interventions

Unicompartmental knee arthroplasty 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); Fixed cemented UKP; Fixed cementless UKP; Mobile Cemented UKP; Mobile Cementless UKP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female adult for whom a unicondylar knee prosthesis is indicated according to U-Knee / Uni-Kroma instructions for use. Patients will be followed according to current practice

You may qualify if:

• \- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Societe dEtude, de Recherche et de Fabrication: lead

Study Sites (1)

CHU Lyon Sud

Pierre-Bénite, France

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Clinical Department

CONTACT

0472056010; clinical@serf.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2035
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (1)