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

Ambispective Open Multicentric Study Evaluating Clinical Results of Unicondylar Knee Arthroplasty Performed With U-Knee/Uni-Kroma Implants

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.

Study Overview

• Status: Recruiting
• Conditions: Unicompartmental Knee Arthroplasty
• Intervention / Treatment: Device: Unicompartmental knee arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Clinical Department; Phone Number: +33 0472056010; Email: clinical@serf.fr

Study Locations

• France
  • Pierre-Bénite, France
    • Recruiting
    • CHU Lyon Sud
    • Contact: Anthony Viste

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fixed cementless UKP; Patient implanted with a fixed cementless Unicompartmental prosthesis	Device: 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.
Fixed cemented UKP; Patient implanted with a fixed cemented Unicompartmental prosthesis	Device: 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.
Mobile Cementless UKP; Patient implanted with a mobile cementless Unicompartmental prosthesis	Device: 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.
Mobile Cemented UKP; Patient implanted with a mobile cemented Unicompartmental prosthesis	Device: 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.
Fixed Cementless UKP (TIT coating); Patient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT"	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Assess the survival rate of the investigational medical devices at 5 year follow-up	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Societe dEtude, de Recherche et de Fabrication

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): January 31, 2035

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Knee
• Other Study ID Numbers: 2022-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No