Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis

Waldemar Link (LINK)

Status: Enrolling

Conditions: Osteoarthrosis of Knee

Treatments: Device: Total knee replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT04858347

KP11

Details and patient eligibility

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.

Full 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 and safety. Currently, no mid- and longterm clinical data are available for the GEMINI SL Fixed Bearing PS knee prosthesis. Therefore, the study is designed to generate clinical data of the GEMINI SL Fixed Bearing PS knee prosthesis in the 10-year follow-up under routine condition.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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