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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT01783483
First received: January 31, 2013
Last updated: August 7, 2017
Last verified: August 2017
  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
Coronary Artery Disease Angina Pectoris Cardiac Valve Disease Device: SternaLock Blue closure system Device: Suture Wire

Study Type: Interventional
Study Design: 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

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • 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

  • 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:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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).

  • 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) .

  • 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) .

  • 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) .

  • 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) .


Enrollment: 236
Study Start Date: January 2013
Study Completion Date: December 2016
Primary Completion Date: June 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   (Adult, Senior)
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
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

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

Additional Information:
Publications:

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01783483     History of Changes
Other Study ID Numbers: 0712
SLBlu ( Other Identifier: Biomet Microfixation )
Study First Received: January 31, 2013
Results First Received: December 16, 2016
Last Updated: August 7, 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

ClinicalTrials.gov processed this record on September 19, 2017