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 Type
OBSERVATIONAL
Enrollment
400
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.
CHU Lyon Sud
Pierre-Bénite, France
RECRUITINGSurvival rate
Assess the survival rate of the investigational medical devices at 5 year follow-up
Time frame: 5 years
Survival rate
Assess the survival rate of the investigational medical devices at 12-18 months, 3 years and 10 years follow-up
Time frame: 12-18 months to 10 years
Functional improvement
Restoration of mobility and pain reduction evaluation using IKS score
Time frame: From pre-operative to 10 years
Functional improvement
Evaluate pain, symptoms, activities of daily life and sports activity using KOOS score
Time frame: From pre-operative to 10 years
Forgetfulness of prosthesis
Evaluate the degree of forgetfulness of the prostheses using FJS- score
Time frame: From pre-operative to 10 years
Activity
Evaluate the degree of activity using Devane score
Time frame: From pre-operative to 10 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.