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Sternal Plating High Risk

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Start date changed from estimate of Feb 10, 2026 to Mar 12, 2026
    • Site details revised
    v7
  2. Start date: Nov 1, 2025 to Feb 10, 2026v6
  3. Start date: Aug 1, 2025 to Nov 1, 2025v5
  4. Start date: Jun 1, 2025 to Aug 1, 2025v4
  5. Start date: Mar 1, 2025 to Jun 1, 2025v3
  6. Lead sponsor: Marc Pelletier to University Hospitals Cleveland Medical Center
    • Start date: Dec 31, 2024 to Mar 1, 2025
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06660186
Lead Sponsor University Hospitals Cleveland Medical Center
Collaborators: Stryker Nordic
Conditions
(from sponsor)		 Heart Diseases
Related terms Heart Diseases, Pain
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov