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

Not Applicable

Completed

Conditions: Angina Pectoris
Coronary Artery Disease
Cardiac Valve Disease

Interventions: Device: SternaLock Blue closure system
Device: Suture Wire

Registration Number: NCT01783483

Lead Sponsor: Zimmer Biomet

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 236

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SternaLock Blu closure system	SternaLock Blue 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.
Suture Wire	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.).

Primary Outcome Measures

Name	Time	Method
Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing	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
Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing	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

Secondary Outcome Measures

Name	Time	Method
Pain Measured in a 10-point Scale at 3-week Post Operative	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 3-month Post Operative	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 Day 7 Post Operative	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 6-week Post Operative	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
Narcotic Usage	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) .
Pain Measured in a 10-point Scale at 6-month Post Operative	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

Trial Locations

Locations (12): Mayo Clinic Jacksonville
🇺🇸
Jacksonville, Florida, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Franciscan St. Francis Health
🇺🇸
Indianapolis, Indiana, United States
United Heart & Vascular Clinic, United Hospital, part of Allina Health
🇺🇸
Saint Paul, Minnesota, United States
Lenox Hill Hospital
🇺🇸
New York, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
University of Toledo
🇺🇸
Toledo, Ohio, United States
Scott & White Memorial Hospital
🇺🇸
Temple, Texas, United States
Saint Luke's Mid America Heart and Vascular Institute
🇺🇸
Kansas City, Missouri, United States