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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: November 10, 2014
Last verified: February 2014

January 31, 2013
November 10, 2014
January 2013
August 2015   (final data collection date for primary outcome measure)
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.
Evaluation of sternal bone healing, as defined by CT scan assessment. [ Time Frame: 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.
Complete list of historical versions of study NCT01783483 on ClinicalTrials.gov Archive Site
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

Pain [ Time Frame: Baseline, Post-Op hospital stay, 3-week, 6-week, 3-month and 6-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 and 6-month post-op.

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.
Narcotic Usage [ Time Frame: Baseline, Surgery, ICU stay, Genarl Floor Stay, Discharge, 3-week, 6-week, 3-month and 6-month ] [ Designated as safety issue: No ]
Pain medication usage will be tabulated and recorded at each follow-up interval.
 
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Coronary Artery Disease
  • Angina Pectoris
  • Cardiac Valve Disease
  • Device: SternaLock Blue closure system
    SternaLock Blue closure system is a primary closure system plate-based
    Other Name: SternaLock, SternalBlu
  • Device: Suture Wire
    Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
  • 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.).
    Intervention: Device: Suture Wire
  • 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.
    Intervention: Device: SternaLock Blue closure system

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
236
August 2016
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Brian Hatcher, PhD 904-741-9442 brian.hatcher@biomet.com
United States
 
NCT01783483
0712, SLBlu
Yes
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Keith B Allen, M.D. St Luke's Mid America and Vascular Institute
Biomet, Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP