An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
This trial is active, not recruiting.
|Conditions||coronary artery disease, angina pectoris, cardiac valve disease|
|Treatments||sternalock blue closure system, suture wire|
|Start date||January 2013|
|End date||June 2015|
|Trial size||236 participants|
|Trial identifier||NCT01783483, 0712, SLBlu|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Jacksonville, FL||Mayo Clinic Jacksonville||no longer recruiting|
|Orlando, FL||Florida Hospital||no longer recruiting|
|Atlanta, GA||Emory University||no longer recruiting|
|Indianapolis, IN||Franciscan St. Francis Health||no longer recruiting|
|Louisville, KY||University of Louisville||no longer recruiting|
|St Paul, MN||United Heart & Vascular Clinic, United Hospital, part of Allina Health||no longer recruiting|
|Kansas City, MO||Saint Luke's Mid America Heart and Vascular Institute||no longer recruiting|
|New York City, NY||Columbia University Medical Center||no longer recruiting|
|New York, NY||Lenox Hill Hospital||no longer recruiting|
|Toledo, OH||University of Toledo||no longer recruiting|
|Philadelphia, PA||Temple University Hospital||no longer recruiting|
|Temple, TX||Scott & White Memorial Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
|Primary purpose||supportive care|
Evaluation of sternal bone healing, as defined by CT scan assessment.
time frame: 3-month and 6-month post-op.
time frame: Baseline, Post-Op hospital stay, 3-week, 6-week, 3-month, 6-month and 12-month
Male or female participants at least 18 years old.
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
|Official title||An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial|
|Principal investigator||Keith B Allen, M.D.|
|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.|
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