Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
Key facts
- Where
- Cali, ColombiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04858347, who can take part
Where in Colombia
- Centro Medico Imbanaco Sede PrincipalCali, ColombiaContact: Julio Cesar Palacio Villegas, Dr.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Waldemar Link GmbH & Co. KG
- Trial code
- NCT04858347
- Record updated
- 12 January 2023
- Original description
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.Read full original descriptionShow less
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up
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.
Inclusion: Signed patient informed consent; Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis; Age between 18 and 80 years.
Exclusion: 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; Body Mass Index (BMI) > 40 kg/m²; Foreseeable life expectancy under 5 years; 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.