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

RECRUITINGSponsored by Waldemar Link GmbH & Co. KG
Actively Recruiting
SponsorWaldemar Link GmbH & Co. KG
Started2019-07-04
Est. completion2034-10
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04858347

Summary

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.

Eligibility

Age: 18 Years – 80 YearsHealthy volunteers accepted
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

Conditions2

ArthritisOsteoarthrosis of Knee

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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