Unicompartmental Knee Arthroplasty
Conditions
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.
Interventions
DEVICEUnicompartmental 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.
Sponsors
Societe dEtude, de Recherche et de Fabrication
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 5 years | Assess the survival rate of the investigational medical devices at 5 year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | 12-18 months to 10 years | Assess the survival rate of the investigational medical devices at 12-18 months, 3 years and 10 years follow-up |
| Functional improvement | From pre-operative to 10 years | Restoration of mobility and pain reduction evaluation using IKS score |
| Forgetfulness of prosthesis | From pre-operative to 10 years | Evaluate the degree of forgetfulness of the prostheses using FJS- score |
| Activity | From pre-operative to 10 years | Evaluate the degree of activity using Devane score |
Countries
France
Contacts
CONTACTClinical Department
Outcome results
None listed