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

Completed · Not applicable

Conditions studied: Coronary Artery Disease, Angina Pectoris, Cardiac Valve Disease

In brief

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.

Key facts

Study ID

NCT01783483

Run by

Zimmer Biomet

People needed

236

Starts

2013-01-01

Expected to finish

2016-12-01

Last updated by the study team

2017-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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