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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease, Angina Pectoris, Cardiac Valve Disease

Intervention / Treatment
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* Device: SternaLock Blue closure system
* Device: Suture Wire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suture Wire<br>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<br>* Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.<br>|
| Experimental: SternaLock Blu closure system<br>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<br>* SternaLock Blue closure system is a primary closure system plate-based<br>* Other names: SternaLock, SternalBlu;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | 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 | 3-month post-op | 
| Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing | 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 | 6-month post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Measured in a 10-point Scale at Day 7 Post Operative | 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 | Day 7 | 
| Pain Measured in a 10-point Scale at 3-week Post Operative | 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-week Post-op | 
| Pain Measured in a 10-point Scale at 6-week Post Operative | 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-week Post-op | 
| Pain Measured in a 10-point Scale at 3-month Post Operative | 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-month Post-op | 
| Pain Measured in a 10-point Scale at 6-month Post Operative | 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-month Post-op | 
| Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED). | Index (Day 0 to Hospital Discharge) | 
| Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | From Hospital Discharge to 3-week post-op | 
| Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | From 3-week to 6-week post-op | 
| Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | From 6-week to 3-month post-op | 
| Narcotic Usage | Narcotics usage was tabulated and recorded at each follow-up interval and converted to Morphine Equivalence Dose (MED) . | From 3-month to 6 month post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Valve replacement, sternal closure, midline sternotomy, sternal plates