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NCT Number: NCT01783483

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Cardiac Valve Disease Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Jacksonville, Jacksonville, Florida, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SternaLock Blue closure system

Device

SternaLock Blue closure system is a primary closure system plate-based

Other names: SternaLock, SternalBlu

Suture Wire

Device

Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.

Primary outcomes

  1. 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

    • - Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were nonsclerotic, concave, or irregular
    • - 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
    • - 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
    • - Moderate synthesis: Bridging bone along 50% or more of the antero-posterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome

  2. 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

    • - Indeterminate: No contact or mineralization between the sternal halves, but osteotomy margins were non-sclerotic, concave, or irregular
    • - 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
    • - 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
    • - Moderate synthesis: Bridging bone along 50% or more of the anteroposterior dimension of the sternal haves 5- Sternal halves well-aligned. Best outcome

Secondary outcomes

  1. 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:

    • At rest
    • After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience

  2. 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:

    • At rest
    • After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience

  3. 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:

    • At rest
    • After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience

  4. 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:

    • At rest
    • After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience

  5. 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:

    • At rest
    • After forced coughing. Patients score pain 0 to 10 where 0 represents no pain and 10 represents the worst pain a patient can experience

  6. 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).

  7. 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) .

  8. 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) .

  9. 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) .

  10. 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) .

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

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

Acronym: SB

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Feb 5, 2013
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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