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Sternal Plating High Risk

NCT06660186 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-30

No results posted yet for this study

Summary

Participants are being invited to participate in a research study at University Hospitals because they have heart disease and are scheduled for open heart surgery. Currently, UH cardiac surgeons close the sternum (or breastbone) after a sternotomy (procedure that allows a doctor to reach the heart and blood vessels) with either a rigid plate fixation Sternal Plate or a Wire Cerclage. However, the study team would like to further evaluate these two techniques. Any volunteer over the age of 18 who is at an increased risk for developing sternal wound complications may be eligible to participate.

Conditions

  • Heart Diseases

Interventions

DEVICE

Rigid Sternal Fixation

The surgeon will close the sternum (breastbone) using the SternalPlate system. The SternalPlate System consists of implants and instruments used to hold the two halves of the sternum together.

DEVICE

Wire Cerclage

The surgeon will close the sternum (breastbone) using Wire Cerclage. Wire Cerclage consists of stainless steel wires used to hold the two halves of your sternum together.

Sponsors & Collaborators

  • Stryker Nordic

    collaborator INDUSTRY

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Marc Pelletier, MD · University Hospitals

  • Rakesh Arora, MD · University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-12
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660186 on ClinicalTrials.gov