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

NCT03575546 | Unknown

• 1 other identifier: KP05A
• Study Type: observational
• Target: 254
• Locations: 2 countries
• Sites: 3

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.

Conditions

Total Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point

  3 years

• 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

• Complication rates

  3 and 5 years

• Subsequent surgical interventions

  3 and 5 years

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Waldemar Link GmbH & Co. KG: lead

Study Sites (3)

Klinik Oberammergau

Oberammergau, 82487, Germany

Location

Universitätsklinikum Tübingen für Orthopädie

Tübingen, 72076, Germany

Location

Hospital central de la Cruz Roja

Madrid, 28003, Spain

Location

Study Officials

• Prof. Dr. med. Wülker

  Universitätsklinikum Tübingen für Orthopädie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 2, 2018
• Study Start: July 24, 2018
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

DE (2); ES (1)