Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

229 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-18

Study Completion Date

2023-04-07

Brief Summary

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The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the "OPTICABG" as well as in the "PREMIVALVE" study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. "OPTICABG" patients were followed up 3 months after surgery and "PREMIVALVE" patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.

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Detailed Description

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Conditions

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Coronary Artery Disease Cardiac Valve Insufficiency Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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STEELEX

Steelex® Sternum Set for sternal closure

Sternum Closure after Cardiac Surgery

Intervention Type DEVICE

Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.

Interventions

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Sternum Closure after Cardiac Surgery

Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
* PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
* Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent
* Age ≥18 years