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

Active, not recruiting

• Conditions: Total Knee Replacement

• Registration Number: NCT03575546
• Lead Sponsor: Waldemar Link GmbH & Co. KG

Brief 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.

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-02
• Study Start: 2018-07-24
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-13
• Primary Completion: 2024-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• Implantation of a Gemini SL Fixed Bearing knee prostheses 3 years ago
• Age between 18 and 75 years at the time of implantation

Exclusion Criteria

• Body Mass Index (BMI) > 40 kg/m² at the time of implantation
• Comorbidities and known medical circumstances which would affect the clinical functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
• Prisoner

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point	5 years	Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau.

Secondary Outcome Measures

Name	Time	Method
Subsequent surgical interventions	3 and 5 years	Number and kind of subsequent surgical interventions
Complication rates	3 and 5 years	Number and kind of complications
Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point	3 years	Revision for any reason is defined as removal, replacement or adding of any implant components, except subsequent implantation or replacement of the patella surface or the polyethylene plateau.
Evaluation of the functional and clinical outcome of the Gemini SL Fixed Bearing knee prosthesis measured by the Knee Society Score	3 and 5 year	Evaluation of KSS Score (Validated Score)

Trial Locations

Locations (3)

Hospital central de la Cruz Roja; 🇪🇸 Madrid, Spain

Universitätsklinikum Tübingen für Orthopädie; 🇩🇪 Tübingen, Germany

Klinik Oberammergau; 🇩🇪 Oberammergau, Germany