N/A
N=236
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
Coronary Artery Disease · Angina Pectoris · Cardiac Valve Disease
Bottom Line
View on ClinicalTrials.gov: NCT01783483 ↗Enrolled (actual)
236
Serious AEs
5.1%
Results posted
Sep 2017
Primary outcome: Primary: Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing — 1.8; 2.6 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SternaLock Blue closure system (Device); Suture Wire (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sternal Healing Score at 3 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing |
1.8; 2.6 | <0.0001 sig |
| PRIMARY Sternal Healing Score at 6 Month Post op, as Defined by a 6-point Scale to Evaluate Bone Healing |
3.3; 3.8 | 0.0007 sig |
| SECONDARY Pain Measured in a 10-point Scale at Day 7 Post Operative |
2.10; 1.07; 4.23; 2.20 | 0.0539 |
| SECONDARY Pain Measured in a 10-point Scale at 3-week Post Operative |
1.04; 0.79; 2.99; 1.92 | 0.2125 |
| SECONDARY Pain Measured in a 10-point Scale at 6-week Post Operative |
1.14; 0.54; 1.90; 1.26 | 0.0049 sig |
| SECONDARY Pain Measured in a 10-point Scale at 3-month Post Operative |
0.46; 0.39; 1.01; 0.74 | 0.6653 |
| SECONDARY Pain Measured in a 10-point Scale at 6-month Post Operative |
0.65; 0.55; 0.76; 0.54 | — |
| SECONDARY Narcotic Usage |
48.32; 3.00 | 0.113 |
| SECONDARY Narcotic Usage |
48.32; 3.00 | 0.113 |
| SECONDARY Narcotic Usage |
48.32; 3.00 | 0.113 |
| SECONDARY Narcotic Usage |
48.32; 3.00 | 0.113 |
| SECONDARY Narcotic Usage |
48.32; 3.00 | 0.113 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01783483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.