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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed cementless UKP | Patient implanted with a fixed cementless Unicompartmental prosthesis |
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| Fixed cemented UKP | Patient implanted with a fixed cemented Unicompartmental prosthesis |
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| Mobile Cementless UKP | Patient implanted with a mobile cementless Unicompartmental prosthesis |
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| Mobile Cemented UKP | Patient implanted with a mobile cemented Unicompartmental prosthesis |
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| Fixed Cementless UKP (TIT coating) | Patient implanted with a fixed cementless Unicompartmental prosthesis coating with "TIT" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unicompartmental knee arthroplasty | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | Assess the survival rate of the investigational medical devices at 5 year follow-up | 5 years |
| 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 |
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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:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Department | Contact | 0472056010 | +33 | clinical@serf.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lyon Sud | Recruiting | Pierre-Bénite | France |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| 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 |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |