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

Coronary Artery Disease Clinical Trial

— SB  

Official title:

An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01783483
• Other study ID #: 0712
• Secondary ID: SLBlu
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 31, 2013
• Last updated: October 17, 2016
• Start date: January 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Biomet, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Angina Pectoris
• Cardiac Valve Disease
• Coronary Artery Disease
• Coronary Disease
• Heart Valve Diseases
• Myocardial Ischemia

Intervention

Device:
• SternaLock Blue closure system
SternaLock Blue closure system is a primary closure system plate-based
• Suture Wire
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Saint Luke's Mid America Heart and Vascular Institute	Kansas City	Missouri
United States	University of Louisville	Louisville	Kentucky
United States	Lenox Hill Hospital	New York	New York
United States	Columbia University Medical Center	New York City	New York
United States	Florida Hospital	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	United Heart & Vascular Clinic, United Hospital, part of Allina Health	St Paul	Minnesota
United States	Scott & White Memorial Hospital	Temple	Texas
United States	University of Toledo	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Biomet, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View 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. — View 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. — View 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. — View 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. — View 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):1720-4. doi: 10.1097/PRS.0b013e3181d51292. — View Citation

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. — View 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. — View Citation

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. — View 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. Epub 2006 Apr 25. — View Citation

Raman J, Straus D, Song DH. Rigid plate fixation of the sternum. Ann Thorac Surg. 2007 Sep;84(3):1056-8. — View 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. Epub 2007 Nov 26. Review. — View 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Narcotic Usage	Pain medication usage will be tabulated and recorded at each follow-up interval.	Baseline, Surgery, ICU stay, General Floor Stay, Discharge, 3-week, 6-week, 3-month, 6-month and 12-month	No
Primary	Evaluation of sternal bone healing, as defined by CT scan assessment.	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.	3-month and 6-month post-op.	No
Secondary	Pain	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	Baseline, Post-Op hospital stay, 3-week, 6-week, 3-month, 6-month and 12-month	No

External Links

•   SternaLock Blu Primary Closure System Brochure
•   SternaLock Blu Product Description