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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03575546

Enrollment

254

Registered

2018-07-02

Start date

2018-07-24

Completion date

2025-09-30

Last updated

2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Germany, Spain

Outcome results