Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
ConditionOsteoarthrosis of Knee
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorWaldemar Link GmbH & Co. KG
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.
Eligibility criteria
Qualifiers
Signed patient informed consent
Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
Age between 18 and 80 years
Disqualifiers
Body Mass Index (BMI) > 40 kg/m²
Foreseeable life expectancy under 5 years
Comorbidities and known medical circumstances which would affect the clinical or functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
Patient who is mentally not able to understand the study and the study conduct
Trial design
Treatments tested in this trial
- Total knee replacement
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov