Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Total knee replacement.
- Who it may be relevant to
- Registry conditions: Osteoarthrosis of Knee. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up
Overview
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.
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 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.
Interventions
- Device Total knee replacement
Implantation of the GEMINI SL Fixed Bearing PS knee prosthesis. The operation technique of the GEMINI SL Fixed Bearing PS knee prosthesis will be followed.
Primary outcome measures
- 10-year survival rate of the Gemini SL Fixed Bearing PS knee prothesis [Time frame: 10 years]
Secondary outcome measures (5)
- Survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis [Time frame: after 6 months, 1,3 and 5 years]
- Change in functional and clinical outcome (KOOS) [Time frame: preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years]
- Change in functional and clinical outcome (KSS) [Time frame: preoperative examination to postoperative examinations after 6 months, 1, 3, 5 and 10 years]
- Complications rate [Time frame: Intraoperative examinations to 10-year follow-up examination]
- Subsequent surgical interventions [Time frame: postoperative examinations up to 10-year follow-up examination]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Colombia · 1 center
- Centro Medico Imbanaco Sede Principal — Cali
Identifiers
NCT: NCT04858347 · KP11