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NCT03575546 Clinical Trial

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

Total Knee Replacement Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03575546
Other study ID # KP05A
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 24, 2018
Est. completion date September 2025

Study information
Verified date January 2023
Source Waldemar Link GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 254
Est. completion date September 2025
Est. primary completion date September 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Klinik Oberammergau Oberammergau
Germany Universitätsklinikum Tübingen für Orthopädie Tübingen
Spain Hospital central de la Cruz Roja Madrid

Sponsors (1)
Lead Sponsor Collaborator
Waldemar Link GmbH & Co. KG

Countries where clinical trial is conducted

Germany,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point 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. 5 years
Secondary Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point 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. 3 years
Secondary Evaluation of the functional and clinical outcome of the Gemini SL Fixed Bearing knee prosthesis measured by the Knee Society Score Evaluation of KSS Score (Validated Score) 3 and 5 year
Secondary Complication rates Number and kind of complications 3 and 5 years
Secondary Subsequent surgical interventions Number and kind of subsequent surgical interventions 3 and 5 years
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