Sternal Plating High Risk

Randomized Trial of Rigid Plate Fixation Versus Wire Cerclage in High-Risk Sternotomy Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases
• Intervention / Treatment: Device: Rigid Sternal Fixation; Device: Wire Cerclage

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stacey Mazzurco; Phone Number: 216-844-3130; Email: Stacey.Mazzurco@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals
      • Contact: Stacey Mazzurco; Phone Number: 216-844-3130; Email: Stacey.Mazzurco@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Preoperative Inclusion Criteria

• Adults (age range: 18-89)

• Undergoing cardiac surgery through sternotomy

  -≥2 risk factors:

• Diabetes mellitus
• Severe COPD
• Chronic steroid use
• Immunosuppression
• Redo sternotomy
• Chronic
• Kidney disease with GFR >30 ml/min per 1.73m2
• Radiation therapy
• BMI≥35
• High-risk of delirium
• Heavy alcohol use

Preoperative Exclusion Criteria

• Active malignancy
• Chronic narcotic use
• NYHA Class IV
• Known nickel metal allergy
• Compliance concern
• eGFR<30 ml/min per 1.73m2
• Involvement in another interventional clinical trial (non-registry)
• Any criteria precluding RPF or WC

Operative Inclusion Criteria

• Off-midline sternotomy
• BITA grafting
• CPB time ≥120 minutes
• Transverse sternal fracture

Operative Exclusion Criteria

• Emergent or emergent salvage surgery
• Non-standard sternotomies
• Sternotomy with bony margin <2 mm
• Bleeding
• Delayed sternal closure
• Surgical complications
• Any criteria precluding RPF or WC

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sternal healing as measured by CT scan	5 axial CT slices from a priori-defined anatomic locations are selected by a radiologist. Two additional radiologists then independently score each location using a 6-point scale (0, 1, 2, 3, 4, or 5) with higher scores representing greater healing. Sternal union will be pre-specified as a mean score ≥3 (total score ≥15).	6 months
Number of sternal wound complications as measured by patient/physician report	Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).	6 months
Total index hospitalization cost	Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)	6 months
Total cost	All costs after initial discharge through 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain as measured by the Wong-Baker pain scale	From a scale of 0 (no hurts) to 10 (hurts worst)	Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
Change in prescribed narcotic use as measured by patient report	Evaluating mean morphine equivalent	Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months
Change in upper extremity functional index (UEFI)	The UEFI is a validated 20 item questionnaire used for quantifying UEF in performing normal daily activities.	Discharge (up to 10 days), 1 month, 6 months
Change in quality of life as measured by the EuroQol EQ-5D-5L	The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.	Discharge (up to 10 days), 1 month, 6 months
Number of adverse events as measured by patient report	Adverse events of interest not specified above include: damage to soft tissue, organs, or surrounding structures during closure, need for reoperation, loosening of the wires, screws, or plates, fracture of the wires, screws, or plates, and need for hardware removal (wires, screws, or plates).	Up to 6 months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Stryker Nordic
• Investigators: Principal Investigator: Marc Pelletier, MD, University Hospitals; Principal Investigator: Rakesh Arora, MD, University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 23, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Cardiac Surgery; Non-union; Wound Complication; Rigid Sternal Fixation; Sternal Infection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Heart Diseases
• Other Study ID Numbers: STUDY20240513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No