Status:
RECRUITING
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
Lead Sponsor:
Waldemar Link GmbH & Co. KG
Conditions:
Osteoarthrosis of Knee
Eligibility:
All Genders
18-80 years
Brief Summary
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 ...
Detailed Description
The GEMINI SL Fixed Bearing PS knee prosthesis combines clinical proven design features with state-of-the-art-technology in order to achieve a high standard clinical performance, surgical efficiency a...
Eligibility Criteria
Inclusion
- Signed patient informed consent
- Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
- Age between 18 and 80 years
Exclusion
- 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
- Patients who will be foreseeable non-compliant to the planned routine interventions and study related follow-ups
- Prisoner
- Pregnant women
Key Trial Info
Start Date :
July 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2035
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04858347
Start Date
July 4 2019
End Date
October 1 2035
Last Update
January 12 2023
Active Locations (1)
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1
Centro Medico Imbanaco Sede Principal
Cali, Valle del Cauca Department, Colombia