Clinical trial NCT01783483: An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
Official title: An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Cardiac Valve Disease
Keywords: CABG
Valve replacement
sternal closure
midline sternotomy
sternal plates
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing
timeFrame: 3-month post-op
measure: Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing
timeFrame: 6-month post-op
Secondary outcomes:
measure: Pain Measured in a 10-point Scale at Day 7 Post Operative
timeFrame: Day 7
measure: Pain Measured in a 10-point Scale at 3-week Post Operative
timeFrame: 3-week Post-op
measure: Pain Measured in a 10-point Scale at 6-week Post Operative
timeFrame: 6-week Post-op
measure: Pain Measured in a 10-point Scale at 3-month Post Operative
timeFrame: 3-month Post-op
measure: Pain Measured in a 10-point Scale at 6-month Post Operative
timeFrame: 6-month Post-op
measure: Narcotic Usage
timeFrame: Index (Day 0 to Hospital Discharge)
measure: Narcotic Usage
timeFrame: From Hospital Discharge to 3-week post-op
measure: Narcotic Usage
timeFrame: From 3-week to 6-week post-op
measure: Narcotic Usage
timeFrame: From 6-week to 3-month post-op
measure: Narcotic Usage
timeFrame: From 3-month to 6 month post-op
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Franciscan St. Francis Health
state: Indiana
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Saint Paul
country: United States
facility: United Heart & Vascular Clinic, United Hospital, part of Allina Health
state: Minnesota
city: Kansas City
country: United States
facility: Saint Luke's Mid America Heart and Vascular Institute
state: Missouri
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
Study officials:
affiliation: St Luke's Mid America and Vascular Institute
name: Keith B Allen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1016/s1010-7940(99)00014-7.
citation: 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.
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citation: 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.
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citation: 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.
citation: 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):1720-1724. doi: 10.1097/PRS.0b013e3181d51292.
citation: 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. doi: 10.1016/j.bjps.2007.09.022. Epub 2007 Nov 26.
citation: Raman J, Straus D, Song DH. Rigid plate fixation of the sternum. Ann Thorac Surg. 2007 Sep;84(3):1056-8. doi: 10.1016/j.athoracsur.2006.11.045.
citation: 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. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.
citation: 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. doi: 10.1097/01.sap.0000202825.41069.c3.
citation: 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. doi: 10.1016/j.ejcts.2004.04.038.
citation: Song DH, Agarwal JP, Jeevanandam V. Rigid sternal fixation in the cardiac transplant population. J Thorac Cardiovasc Surg. 2003 Sep;126(3):896-7. doi: 10.1016/s0022-5223(03)00605-6. No abstract available.
citation: 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. doi: 10.1016/j.athoracsur.2005.03.089.