An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery (SB)
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.
Coronary Artery Disease
Cardiac Valve Disease
Device: SternaLock Blue closure system
Device: Suture Wire
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial|
- Evaluation of sternal bone healing, as defined by CT scan assessment. [ Time Frame: 3-month and 6-month post-op. ] [ Designated as safety issue: No ]
CT scans done by an independent core facility will evaluate sternal bone healing with the following parameters:
- Acquire axial images from the lung apices to the costophrenic sulci with the table increment or reconstruction interval equal to or less than the slice thickness. Capture the entire sternum. Slice thickness along the sternum should be at a high spatial resolution thru thin, contiguous image slices (0.8 - 0.9mm). Region scans superior and inferior to the sternum may be made at more customary image slices (3-10 mm) at investigator discretion. CT scans should be taken without contrast.
- All scans should be obtained in the same suspended state of respiration when possible. Scans should be obtained thru the entire area of interest. The field of view should be optimized for each patient.
- Do not use gantry tilt in scanning patients if possible.
- Archive the entire study, preferably in DICOM format, to a removable medium.
- Pain [ Time Frame: Baseline, Post-Op hospital stay, 3-week, 6-week, 3-month, 6-month and 12-month ] [ Designated as safety issue: No ]
Intensity and frequency of sternal pain will be assessed using 10 point scales in the following circumstances:
- At rest
- After 10 breaths
- After ambulation
- After forced coughing
Participants will be assessed for pain pre-op (baseline); for the duration of the hospital stay, an expected average of 5 days; at 3-week post-op; 6-week post-op; 3-month post-op, 6-month post-op and 12-month post-op
- Narcotic Usage [ Time Frame: Baseline, Surgery, ICU stay, General Floor Stay, Discharge, 3-week, 6-week, 3-month, 6-month and 12-month ] [ Designated as safety issue: No ]Pain medication usage will be tabulated and recorded at each follow-up interval.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2016|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Suture Wire
The closure technique should be per surgeon and institutional preference, with documentation of the wiring technique including the wiring configuration and number of wires used. A minimum of 6 wires that cross the midline sternotomy should be used (e.g. 6 simple wires, 3 double wires, 3 figure of 8 wires, etc.).
Device: Suture Wire
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
Experimental: SternaLock Blu closure system
Patients will receive treatment option for sternal closure with the SternaLock Blue closure system at a minimum of 2 "X" plates on the sternal body and 1 "L" plate (or equivalent) on the manubrium. This technique is the standard configuration for this study, and is intended to ensure that at least 3 plates are used to achieve adequate fixation and stability, while allowing for variations in the plating configuration as a result of patient anatomy and surgeon preference. Various Sternal Blu plates may be used on the manubrium as described below, as can an additional plate on the sternal body.
Device: SternaLock Blue closure system
SternaLock Blue closure system is a primary closure system plate-based
Other Name: SternaLock, SternalBlu
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783483
|United States, Florida|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|Orlando, Florida, United States, 32803|
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|United States, Indiana|
|Franciscan St. Francis Health|
|Indianapolis, Indiana, United States, 46237|
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Minnesota|
|United Heart & Vascular Clinic, United Hospital, part of Allina Health|
|St Paul, Minnesota, United States, 55102|
|United States, Missouri|
|Saint Luke's Mid America Heart and Vascular Institute|
|Kansas City, Missouri, United States, 64111|
|United States, New York|
|Lenox Hill Hospital|
|New York, New York, United States, 10065|
|Columbia University Medical Center|
|New York City, New York, United States, 10032|
|United States, Ohio|
|University of Toledo|
|Toledo, Ohio, United States, 43614|
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|
|United States, Texas|
|Scott & White Memorial Hospital|
|Temple, Texas, United States, 76508|
|Principal Investigator:||Keith B Allen, M.D.||St Luke's Mid America and Vascular Institute|