Actively Recruiting
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
Led by Waldemar Link GmbH & Co. KG · Updated on 2023-01-12
350
Participants Needed
1
Research Sites
847 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed patient informed consent
- Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
- Age between 18 and 80 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Centro Medico Imbanaco Sede Principal
Cali, Valle del Cauca Department, Colombia
Actively Recruiting
Research Team
K
Kim Jacobs
CONTACT
R
Romy Spitzmüller
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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