Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
Recruiting
Observational Study
Osteoarthrosis of Knee
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Observational
- Participants needed
- 350 (estimated)
- Sponsor
- Waldemar Link GmbH & Co. KG · Industry
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About This Trial
This is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis in longterm follow-up under routine conditions. Primary outcome of the study is the 10-year survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis with revision for any reason as the endpoint.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Signed patient informed consent
* Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
* Age between 18 and 80 years
Exclusion Criteria:
* Body Mass Index (BMI) \> 40 kg/m²
* Foreseeable life expectancy under 5 years
* Comorbidities and known medical circumstances wh…
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