M17 M87 M12
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Signed Patient informed consent - Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis - age between 18 and 75 years
Exclusion criteria
Exclusion criteria: - Body Mass Index (BMI) > 40 kg/m2 - poor general health with an expected life expectation under 5 years - known comorbidities and medical conditions, which foreseeable affect the clinical and functional outcome of the knee prosthesis, eg. neurological and musculosceletal disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 10-year survival rate of the GEMINI SL Fixed Bearing PS with revision for any reason as the endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 6 month, 1-, 3. and 5 -year survival rate of the GEMINI SL Fixed Bearing PS with revision for any reason as the endpoint Evaluation of the functional and clinical outcome from pre- to postoperative follow-ups after 6 month, 1-, 3, 5 and 10-years by using the KSS score - Complications and revisions | — |
Countries
Germany
Contacts
Waldemar Link GmbH & Co KG.