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

Study Overview
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Brief Summary
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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.

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

Conditions
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Unicompartmental Knee Arthroplasty

Intervention / Treatment
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* Device: Unicompartmental knee arthroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fixed cementless UKP<br>Patient implanted with a fixed cementless Unicompartmental prosthesis | Device: Unicompartmental knee arthroplasty<br>* 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.<br>|
| Fixed cemented UKP<br>Patient implanted with a fixed cemented Unicompartmental prosthesis | Device: Unicompartmental knee arthroplasty<br>* 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.<br>|
| Mobile Cementless UKP<br>Patient implanted with a mobile cementless Unicompartmental prosthesis | Device: Unicompartmental knee arthroplasty<br>* 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.<br>|
| Mobile Cemented UKP<br>Patient implanted with a mobile cemented Unicompartmental prosthesis | Device: Unicompartmental knee arthroplasty<br>* 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.<br>|
| Fixed Cementless UKP (TIT coating)<br>Patient implanted with a fixed cementless Unicompartmental prosthesis coating with TIT | Device: Unicompartmental knee arthroplasty<br>* 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.<br>|

What is the study measuring?
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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 |