The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage. Additional outcomes on post-operative pain and analgesic usage, patient function and quality of life, and complications will also be collected. A health economics study will also be conducted, in which cost and billing data will be collected from sites participating in this clinical study.
Rigid sternal fixation with the BIOMET SternaLock Blu Sternal Closure System may result in greater sternal stability that leads to superior sternal bone healing, less postoperative pain and narcotic usage, and improved functional outcomes compared to wire cerclage. The health economics analysis is an interesting component of this study, in which cost and billing data will be collected from participating sites and analyzed in terms of cost/effectiveness for patients and healthcare system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
236
SternaLock Blue closure system is a primary closure system plate-based
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Florida Hospital
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing
Parameters for scoring: 0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome 1. \- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular 2. \- Early healing: Faint mineralization between noncontacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins 3. \- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension 4. \- Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome
Time frame: 3-month post-op
Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing
Parameters for scoring: 0 - Nonunion: No contact between sternal halves, absence of gap mineralization, and sclerotic osteotomy margins similar to that of cortical bone. Worst outcome 1. \- Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular 2. \- Early healing: Faint mineralization between non-contacting sternal halves, or a thin (1 mm) bridge of bone connecting the sternal halves anteriorly or posteriorly, or near bone-on-bone contact between the sternal halves, with sclerotic osteotomy margins 3. \- Mild synthesis: Bridging bone (i.e., no perceptible gap) along less than 50% of the anteroposterior dimension of the sternal halves, with the sternal halves either offset in the anteroposterior dimension, or aligned in the anteroposterior dimension 4. \- Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome
Time frame: 6-month post-op
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Franciscan St. Francis Health
Indianapolis, Indiana, United States
University of Louisville
Louisville, Kentucky, United States
United Heart & Vascular Clinic, United Hospital, part of Allina Health
Saint Paul, Minnesota, United States
Saint Luke's Mid America Heart and Vascular Institute
Kansas City, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
University of Toledo
Toledo, Ohio, United States
...and 2 more locations
Pain Measured in a 10-point Scale at Day 7 Post Operative
Intensity of sternal pain assessed using 10 point scale: 1. At rest 2. After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
Time frame: Day 7
Pain Measured in a 10-point Scale at 3-week Post Operative
Intensity of sternal pain assessed using 10 point scale in the following circumstances: 1. At rest 2. After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
Time frame: 3-week Post-op
Pain Measured in a 10-point Scale at 6-week Post Operative
Intensity of sternal pain assessed using 10 point scale in the following circumstances: 1. At rest 2. After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
Time frame: 6-week Post-op
Pain Measured in a 10-point Scale at 3-month Post Operative
Intensity of sternal pain assessed using 10 point scale in the following circumstances: 1. At rest 2. After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
Time frame: 3-month Post-op
Pain Measured in a 10-point Scale at 6-month Post Operative
Intensity of sternal pain assessed using 10 point scale in the following circumstances: 1. At rest 2. After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
Time frame: 6-month Post-op
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED).
Time frame: Index (Day 0 to Hospital Discharge)
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: From Hospital Discharge to 3-week post-op
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: From 3-week to 6-week post-op
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: From 6-week to 3-month post-op
Narcotic Usage
Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
Time frame: From 3-month to 6 month post-op