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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Total Knee Replacement

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 Type: Observational
• Enrollment (Actual): 254

Contacts and Locations

Study Locations

• Germany
  • Oberammergau, Germany, 82487
    • Klinik Oberammergau
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen für Orthopädie
• Spain
  • Madrid, Spain, 28003
    • Hospital Central de la Cruz Roja

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients received a Gemini SL Fixed Bearing knee prosthesis in the study sites 3 years ago are possible participants of the study. Hospital charts will be screened in order to identify these candidates. The patients will be followed up at 3-year interval.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Complication rates	Number and kind of complications	3 and 5 years
Subsequent surgical interventions	Number and kind of subsequent surgical interventions	3 and 5 years

Collaborators and Investigators

• Sponsor: Waldemar Link GmbH & Co. KG
• Investigators: Principal Investigator: Prof. Dr. med. Wülker, Universitätsklinikum Tübingen für Orthopädie

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KP05A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No