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This is a retrospective, multicenter case series with a prospective follow-up to confirm the safety and performance of the Gemini SL Fixed Bearing knee prosthesis in midterm follow-up under routine conditions. Primary outcome of the study is the 5-year survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point.
Sufficient data (e.g. biomechanical tests, biocompatibility, vigilance data and results of risk management, clinical data of comparable devices) are available for assessing the safety and performance of the Gemini SL knee prosthesis system. Unfortunately, no data are available for the Gemini SL Fixed Bearing knee prosthesis. As one part of the post market surveillance (PMS) system of the sponsor, the clinical outcome of the Gemini SL Fixed Bearing knee prosthesis in the midterm follow-up shall be evaluated. Therefore patients who received a Gemini Sl Fixed bearing knee prosthesis 3 years ago are invited to participate in follow-up examinations.
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| Measure | Description | Time Frame |
|---|---|---|
| Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point | Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point | Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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All patients received a Gemini SL Fixed Bearing knee prosthesis in the study sites 3 years ago are possible participants of the study. Hospital charts will be screened in order to identify these candidates. The patients will be followed up at 3-year interval.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. med. Wülker | Universitätsklinikum Tübingen für Orthopädie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik Oberammergau | Oberammergau | 82487 | Germany | |||
| Universitätsklinikum Tübingen für Orthopädie |
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| Evaluation of the functional and clinical outcome of the Gemini SL Fixed Bearing knee prosthesis measured by the Knee Society Score |
Evaluation of KSS Score (Validated Score) |
| 3 and 5 year |
| Complication rates | Number and kind of complications | 3 and 5 years |
| Subsequent surgical interventions | Number and kind of subsequent surgical interventions | 3 and 5 years |
| Tübingen |
| 72076 |
| Germany |
| Hospital central de la Cruz Roja | Madrid | 28003 | Spain |