Study Results
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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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2026-02-10
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Off-midline sternotomy
* BITA grafting
* CPB time ≥120 minutes
* Transverse sternal fracture
Exclusion Criteria
* 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
* 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
18 Years
89 Years
ALL
No
Sponsors
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Stryker Nordic
INDUSTRY
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marc Pelletier, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals
Rakesh Arora, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals
Locations
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University Hospitals
Cleveland, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20240513
Identifier Type: -
Identifier Source: org_study_id
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