About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Unicompartmental knee arthroplasty
DeviceKnee 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.
Treatment groups
Trial outcomes
Primary outcomes
Survival rate
Assess the survival rate of the investigational medical devices at 5 year follow-up
Secondary outcomes
Survival rate
Assess the survival rate of the investigational medical devices at 12-18 months, 3 years and 10 years follow-up
Functional improvement
Restoration of mobility and pain reduction evaluation using IKS score
Functional improvement
Evaluate pain, symptoms, activities of daily life and sports activity using KOOS score
Forgetfulness of prosthesis
Evaluate the degree of forgetfulness of the prostheses using FJS- score
Sponsors and contacts
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