NCT03575546

Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 254 (actual)
• Sponsor: Waldemar Link GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

This is a retrospective, multicenter case series with a prospective follow-up to confirm the safety and performance of the Gemini SL Fixed Bearing knee prosthesis in midterm follow-up under routine conditions. Primary outcome of the study is the 5-year survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point.

Detailed description

Sufficient data (e.g. biomechanical tests, biocompatibility, vigilance data and results of risk management, clinical data of comparable devices) are available for assessing the safety and performance of the Gemini SL knee prosthesis system. Unfortunately, no data are available for the Gemini SL Fixed Bearing knee prosthesis. As one part of the post market surveillance (PMS) system of the sponsor, the clinical outcome of the Gemini SL Fixed Bearing knee prosthesis in the midterm follow-up shall be evaluated. Therefore patients who received a Gemini Sl Fixed bearing knee prosthesis 3 years ago are invited to participate in follow-up examinations.

Conditions

• Total Knee Replacement

Timeline

• Start date: 2018-07-24
• Primary completion: 2024-09-01
• Completion: 2025-09-01
• First posted: 2018-07-02
• Last updated: 2023-01-13

Locations

3 sites across 2 countries: Germany, Spain