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NCT Number: NCT06660186

Sternal Plating High Risk

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.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Cleveland, Ohio, 44106, United States

Location status: Recruiting

Location contact

Stacey Mazzurco

CONTACT

[email protected]

216-844-3130

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rigid Sternal Fixation

Device

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.

Wire Cerclage

Device

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.

Primary outcomes

  1. Sternal healing as measured by CT scan

    Time frame: 6 months

    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).

  2. Number of sternal wound complications as measured by patient/physician report

    Time frame: 6 months

    Sternal wound complications will be a composite of wound dehiscence, sternal dehiscence, SSIs, and DSWIs (synonymous with deep SSIs and mediastinitis).

  3. Total index hospitalization cost

    Time frame: 6 months

    Index hospitalization costs (beginning at the time of surgery and ending at initial discharge)

  4. Total cost

    Time frame: 6 months

    All costs after initial discharge through 6 months

Secondary outcomes

  1. Change in pain as measured by the Wong-Baker pain scale

    Time frame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months

    From a scale of 0 (no hurts) to 10 (hurts worst)

  2. Change in prescribed narcotic use as measured by patient report

    Time frame: Postoperative days 1, 3, day of discharge (up to 10 days), 1 month, 6 months

    Evaluating mean morphine equivalent

  3. Change in upper extremity functional index (UEFI)

    Time frame: Discharge (up to 10 days), 1 month, 6 months

    The UEFI is a validated 20 item questionnaire used for quantifying UEF in performing normal daily activities.

  4. Change in quality of life as measured by the EuroQol EQ-5D-5L

    Time frame: Discharge (up to 10 days), 1 month, 6 months

    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.

  5. Number of adverse events as measured by patient report

    Time frame: Up to 6 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Stacey Mazzurco

CONTACT

[email protected]

216-844-3130

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Stryker Nordic

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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