An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery (SB)

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Angina Pectoris; Cardiac Valve Disease	Device: SternaLock Blue closure system; Device: Suture Wire	Not Applicable

Detailed Description:

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 Design

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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

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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

   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
2. 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

   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

Secondary Outcome Measures :

1. 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:

   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
2. 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:

   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
3. 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:

   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
4. 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:

   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
5. 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:

   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
6. 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).
7. 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) .
8. 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) .
9. 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) .
10. 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) .

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Zimmer Biomet

Investigators

Principal Investigator:	Keith B Allen, M.D.	St Luke's Mid America and Vascular Institute

More Information

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Additional Information:

SternaLock Blu Primary Closure System Brochure 

SternaLock Blu Product Description 

Publications:

Bennett-Guerrero E, Phillips-Bute B, Waweru PM, Gaca JG, Spann JC, Milano CA. Pilot study of sternal plating for primary closure of the sternum in cardiac surgical patients. Innovations (Phila). 2011 Nov;6(6):382-8. doi: 10.1097/IMI.0b013e318248fbda.

Casha AR, Yang L, Kay PH, Saleh M, Cooper GJ. A biomechanical study of median sternotomy closure techniques. Eur J Cardiothorac Surg. 1999 Mar;15(3):365-9.

Chou SS, Sena MJ, Wong MS. Use of SternaLock plating system in acute treatment of unstable traumatic sternal fractures. Ann Thorac Surg. 2011 Feb;91(2):597-9. doi: 10.1016/j.athoracsur.2010.07.083.

Raman J, Lehmann S, Zehr K, De Guzman BJ, Aklog L, Garrett HE, MacMahon H, Hatcher BM, Wong MS. Sternal closure with rigid plate fixation versus wire closure: a randomized controlled multicenter trial. Ann Thorac Surg. 2012 Dec;94(6):1854-61. doi: 10.1016/j.athoracsur.2012.07.085. Epub 2012 Oct 25.

Hirose H, Yamane K, Youdelman BA, Bogar L, Diehl JT. Rigid sternal fixation improves postoperative recovery. Open Cardiovasc Med J. 2011;5:148-52. doi: 10.2174/1874192401105010148. Epub 2011 Jul 4.

Neaman KC, Blount AL, Kim JA, Renucci JD, Hooker RL. Prophylactic sternal plating with pectoralis advancement flaps after sternotomy in patients with a history of chest irradiation. Interact Cardiovasc Thorac Surg. 2011 Mar;12(3):355-8. doi: 10.1510/icvts.2010.247262. Epub 2010 Dec 7.

Snyder CW, Graham LA, Byers RE, Holman WL. Primary sternal plating to prevent sternal wound complications after cardiac surgery: early experience and patterns of failure. Interact Cardiovasc Thorac Surg. 2009 Nov;9(5):763-6. doi: 10.1510/icvts.2009.214023. Epub 2009 Aug 26.

Lee JC, Raman J, Song DH. Primary sternal closure with titanium plate fixation: plastic surgery effecting a paradigm shift. Plast Reconstr Surg. 2010 Jun;125(6):1720-4. doi: 10.1097/PRS.0b013e3181d51292.

Shifrin DA, Sohn SM, Stouffer CW, Hooker RL, Renucci JD. Sternal salvage with rigid fixation in the setting of a massive mediastinal aortic pseudoaneurysm: a case report and review of the literature. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):e17-20. Epub 2007 Nov 26. Review.

Raman J, Straus D, Song DH. Rigid plate fixation of the sternum. Ann Thorac Surg. 2007 Sep;84(3):1056-8.

Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. Epub 2006 Apr 25.

Dickie SR, Dorafshar AH, Song DH. Definitive closure of the infected median sternotomy wound: a treatment algorithm utilizing vacuum-assisted closure followed by rigid plate fixation. Ann Plast Surg. 2006 Jun;56(6):680-5.

Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72.

Song DH, Agarwal JP, Jeevanandam V. Rigid sternal fixation in the cardiac transplant population. J Thorac Cardiovasc Surg. 2003 Sep;126(3):896-7.

Pai S, Gunja NJ, Dupak EL, McMahon NL, Roth TP, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. In vitro comparison of wire and plate fixation for midline sternotomies. Ann Thorac Surg. 2005 Sep;80(3):962-8.

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
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