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RECRUITING
NCT04858347

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

Sponsor: Waldemar Link GmbH & Co. KG

View on ClinicalTrials.gov

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.

Official title: Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis in Short-, Mid-, and Longterm Follow-up

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

350

Start Date

2019-07-04

Completion Date

2035-10

Last Updated

2023-01-12

Healthy Volunteers

No

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.

Locations (1)

Centro Medico Imbanaco Sede Principal

Cali, Valle del Cauca Department, Colombia