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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01783483
First received: January 31, 2013
Last updated: May 1, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Angina Pectoris
Cardiac Valve Disease
Device: SternaLock Blue closure system
Device: Suture Wire
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • 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:

    1. 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.
    2. 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.
    3. Do not use gantry tilt in scanning patients if possible.
    4. Archive the entire study, preferably in DICOM format, to a removable medium.


Secondary Outcome Measures:
  • 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:

    1. At rest
    2. After 10 breaths
    3. After ambulation
    4. 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



Other Outcome Measures:
  • 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.


Estimated Enrollment: 236
Study Start Date: January 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783483

Contacts
Contact: Brian Hatcher, PhD 904-741-9442 brian.hatcher@biomet.com

Locations
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Mauricia Buchannan, RN    904-953-9455    Buchannan.Mauricia@mayo.edu   
Principal Investigator: Kevin Landolfo, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Contact: Katie Carssow    404-686-3357    katherine.lee.carssow@emory.edu   
Principal Investigator: Vinod H. Thourani, M.D.         
United States, Indiana
Franciscan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Molly Miller    317-893-1948    molly.miller@franciscanalliance.org   
Principal Investigator: Marc W. Gerdisch, M.D.         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Terry Blanton, RN    502-587-4381    mary.blanton@louisville.edu   
Principal Investigator: Kendra Grubb, MD         
United States, Minnesota
United Heart & Vascular Clinic, United Hospital, part of Allina Health Recruiting
St Paul, Minnesota, United States, 55102
Contact: Kari Thomas    651-241-2847    Kari.Thomas@allina.com   
Principal Investigator: John F Grehan, MD, PhD         
United States, Missouri
Saint Luke's Mid America Heart and Vascular Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact: Paul J Kennedy, RN       pkennedy@saint-lukes.org   
Contact: Keith Allen, MD       kallen2340@aol.com   
Principal Investigator: Keith B. Allen, M.D.         
United States, New York
Lenox Hill Hospital Recruiting
New York, New York, United States, 10065
Contact: Miriam Lucca-Sussana    212-434-3734    Mluccasusa@NSHS.edu   
Principal Investigator: Gregory P Fontana, MD         
Columbia University Medical Center Recruiting
New York City, New York, United States, 10032
Contact: Khady Ndour    212-342-8528    kn2323@columbia.edu   
Principal Investigator: Yoshifumi Naka, M.D.         
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Mohammed Kashem    215-707-9732    mohammed.kashem@tuhs.temple.edu   
Principal Investigator: Thomas S. Guy, M.D.         
United States, Texas
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Tina C Amlin    254-724-5710    Tamlin@sw.org   
Principal Investigator: Basar Sareyyupoglu, M.D.         
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Keith B Allen, M.D. St Luke's Mid America and Vascular Institute
  More Information

Additional Information:
Publications:

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01783483     History of Changes
Other Study ID Numbers: 0712, SLBlu
Study First Received: January 31, 2013
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
CABG
Valve replacement
sternal closure
midline sternotomy
sternal plates

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 20, 2014