Overview

This trial is active, not recruiting.

Conditions coronary artery disease, angina pectoris, cardiac valve disease
Treatments sternalock blue closure system, suture wire
Phase phase 4
Sponsor Biomet, Inc.
Start date January 2013
End date June 2015
Trial size 236 participants
Trial identifier NCT01783483, 0712, SLBlu

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose supportive care
Arm
(Active Comparator)
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.).
suture wire
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
(Experimental)
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.
sternalock blue closure system SternaLock, SternalBlu
SternaLock Blue closure system is a primary closure system plate-based

Primary Outcomes

Measure
Evaluation of sternal bone healing, as defined by CT scan assessment.
time frame: 3-month and 6-month post-op.

Secondary Outcomes

Measure
Pain
time frame: Baseline, Post-Op hospital stay, 3-week, 6-week, 3-month, 6-month and 12-month

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biomet, Inc..