Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
Recruiting · NCT04858347 · Observational (researchers observe without assigning treatment) · Lead sponsor: Waldemar Link GmbH & Co. KG
View the official record on ClinicalTrials.gov →Interventions studied
Total knee replacement
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 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
Where it is running
1 location listed.
- Centro Medico Imbanaco Sede Principal - Cali, Valle del Cauca Department, Colombia