An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery (SB)
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ClinicalTrials.gov Identifier: NCT01783483 |
Recruitment Status
:
Completed
First Posted
: February 5, 2013
Results First Posted
: September 8, 2017
Last Update Posted
: September 8, 2017
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease Angina Pectoris Cardiac Valve Disease | Device: SternaLock Blue closure system Device: Suture Wire | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 236 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Supportive Care |
Official Title: | An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
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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.).
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Device: Suture Wire
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
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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.
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Device: SternaLock Blue closure system
SternaLock Blue closure system is a primary closure system plate-based
Other Name: SternaLock, SternalBlu
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- Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing [ Time Frame: 3-month post-op ]
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
- - Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular
- - 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
- - 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
- - Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome
- Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing [ Time Frame: 6-month post-op ]
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
- - Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular
- - 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
- - 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
- - Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome
- Pain Measured in a 10-point Scale at Day 7 Post Operative [ Time Frame: Day 7 ]
Intensity of sternal pain assessed using 10 point scale:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
- Pain Measured in a 10-point Scale at 3-week Post Operative [ Time Frame: 3-week Post-op ]
Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
- Pain Measured in a 10-point Scale at 6-week Post Operative [ Time Frame: 6-week Post-op ]
Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
- Pain Measured in a 10-point Scale at 3-month Post Operative [ Time Frame: 3-month Post-op ]
Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
- Pain Measured in a 10-point Scale at 6-month Post Operative [ Time Frame: 6-month Post-op ]
Intensity of sternal pain assessed using 10 point scale in the following circumstances:
- At rest
- After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience
- Narcotic Usage [ Time Frame: Index (Day 0 to Hospital Discharge) ]Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED).
- Narcotic Usage [ Time Frame: From Hospital Discharge to 3-week post-op ]Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
- Narcotic Usage [ Time Frame: From 3-week to 6-week post-op ]Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
- Narcotic Usage [ Time Frame: From 6-week to 3-month post-op ]Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .
- Narcotic Usage [ Time Frame: From 3-month to 6 month post-op ]Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) .

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing a full standard midline sternotomy as a result of a cardiac surgical procedure (i.e. coronary artery bypass graft (CABG) and/or valve replacement along with other cardiac surgical procedures)
- Patients admitted to the hospital the day of or the day before their scheduled surgical procedure
- Patients ≥ 18 years of age
- Patients with a BMI < 40
Exclusion Criteria:
Pre-operative
- Patients with endstage renal failure who are on dialysis
- Patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 < 50% or patients on on-home oxygen)
- Patients on prescribed pre-operative narcotics
- Patients taking chronic steroids, biologics acting as immunosuppressants (e.g. Enbrel (etanercept), Humira (adalimumab), Remicade (infliximab), or chemotherapeutics (iv or oral chemotherapeutics for cancer). Patients using a steroid inhaler for asthma should not be excluded.
- Patients with an active infection as defined by a positive culture
- Patients with foreign body sensitivity
- Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
- Patients defined within the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) functional Class IV for congestive heart failure: i.e., patients with cardiac disease resulting in inability to carry on any physical activity without discomfort (CCS ; NYHA)
- Patients presenting emergent/salvage cardiac acuity as defined per the Society of Thoracic Surgeons (STS) guidelines: i.e., patients undergoing cardiopulmonary resuscitation en route to the operating room or prior to induction of anesthesia (STS)
- Patients unwilling or unable to return for follow-up
Operative
- Patients requiring delayed sternotomy closure
- Patients with an off-midline sternotomy reducing the bony margin between a SternaLock screw body and an osteotomy to within 2mm or less
- Patients presenting intra-operative conditions that in the opinion of the treating surgeon would require or preclude the use of either wire cerclage or rigid fixation, or who are not able to be plated or wired per the protocol (e.g. patients who in the opinion of the surgeon have insufficient quantity of quality of sternal bone; redo sternotomy with excessive fibrous tissue)
- Use of non resorbable (beeswax) bonewax
- Intraoperative death prior to device placement

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783483
United States, Florida | |
Mayo Clinic Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
Florida Hospital | |
Orlando, Florida, United States, 32803 | |
United States, Georgia | |
Emory University | |
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 | |
Saint 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 | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
Lenox Hill Hospital | |
New York, New York, United States, 10065 | |
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 |
Additional Information:
Publications:
Responsible Party: | Zimmer Biomet |
ClinicalTrials.gov Identifier: | NCT01783483 History of Changes |
Other Study ID Numbers: |
0712 SLBlu ( Other Identifier: Biomet Microfixation ) |
First Posted: | February 5, 2013 Key Record Dates |
Results First Posted: | September 8, 2017 |
Last Update Posted: | September 8, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Zimmer Biomet:
CABG Valve replacement sternal closure midline sternotomy sternal plates |
Additional relevant MeSH terms:
Coronary Artery Disease Myocardial Ischemia Coronary Disease Angina Pectoris Heart Valve Diseases Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Chest Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |