MedTrace Logo

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

NCT04858347 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2023-01-12

No results posted yet for this study

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.

Conditions

  • Osteoarthrosis of Knee

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.

Sponsors & Collaborators

  • Waldemar Link GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Julio Cesar Palacio Villegas, Dr. · Centro Medico Imbanaco Sede Principal

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-04
Primary Completion
2034-10-31
Completion
2035-10-31

Countries

  • Colombia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858347 on ClinicalTrials.gov