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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-04

Study Completion Date

2035-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthrosis of Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No