Evaluating the GEMINI SL Knee Prosthesis for Osteoarthrosis
Official title: Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up
Run by Waldemar Link GmbH & Co. KG · NCT04858347 · Data updated 2026-11-12
This study is testing how well the GEMINI SL knee prosthesis works and stays safe for people with osteoarthrosis over a 10-year period.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | Waldemar Link GmbH & Co. KG Industry-sponsored |
| Locations | 1 site (Cali, Valle del Cauca Department) |
| Status | Recruiting |
| Started | July 4, 2019 |
| Main results expected | October 2034 |
| Study ends | October 2035 |
| Registry record updated | January 12, 2023 |
| Trial ID | NCT04858347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 18 to 80 who require a total knee replacement and are undergoing implantation of the GEMINI SL Fixed Bearing PS knee prosthesis.
✕Probably not a fit
Patients with a BMI over 40 kg/m², significant comorbidities affecting outcomes, or those who are mentally unable to understand the study will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the long-term safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis over a planned follow-up period of 10 years. It will involve multiple centers and focus on the 10-year survival rate of the prosthesis, with revision for any reason as the primary endpoint. The study seeks to generate clinical data under routine conditions, as there is currently a lack of mid- and long-term data for this specific knee prosthesis.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of the GEMINI SL knee prosthesis for patients with knee osteoarthrosis.
How similar studies have gone: While this study is focused on a specific prosthesis, similar observational studies have successfully provided long-term data on knee replacements, indicating potential for valuable insights.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Centro Medico Imbanaco Sede Principal
Cali, Valle del Cauca Department, Colombia Recruiting
Study contacts
- Principal investigator: Julio Cesar Palacio Villegas, Dr. — Centro Medico Imbanaco Sede Principal
- Study coordinator: Kim Jacobs
- Email: k.jacobs@link-ortho.com
- Phone: +49 (0)40 53995866
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.