Clinical trial NCT03575546: Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up
Official title: Clinical and Functional Outcome of the Gemini SL Fixed Bearing at Midterm Follow-up
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Total Knee Replacement
Lead sponsor: Waldemar Link GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2018-07-02
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
timeFrame: 5 years
Secondary outcomes:
measure: Survival rate of the Gemini SL Fixed Bearing knee prosthesis with revision for any reason as the end point
timeFrame: 3 years
measure: Evaluation of the functional and clinical outcome of the Gemini SL Fixed Bearing knee prosthesis measured by the Knee Society Score
timeFrame: 3 and 5 year
measure: Complication rates
timeFrame: 3 and 5 years
measure: Subsequent surgical interventions
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Oberammergau
country: Germany
facility: Klinik Oberammergau
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen für Orthopädie
city: Madrid
country: Spain
facility: Hospital central de la Cruz Roja
Study officials:
affiliation: Universitätsklinikum Tübingen für Orthopädie
name: Prof. Dr. med. Wülker
role: PRINCIPAL_INVESTIGATOR
References: