Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up

Conditions
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Total Knee Replacement

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Implantation of a Gemini SL Fixed Bearing knee prostheses 3 years ago Age between 18 and 75 years at the time of implantation Exclusion Criteria: Body Mass Index (BMI) > 40 kg/m² at the time of implantation Comorbidities and known medical circumstances which would affect the clinical functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation Prisoner

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |