An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery (SB)
This study is currently recruiting participants.
Verified May 2013 by Biomet, Inc.
Sponsor:
Biomet, Inc.
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01783483
First received: January 31, 2013
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Angina Pectoris Cardiac Valve Disease |
Device: SternaLock Blue closure system Device: Suture Wire |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery: A Prospective, Randomized Trial |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
Primary Outcome Measures:
- Evaluation of sternal bone healing, as defined by CT scan assessment. [ Time Frame: 6-month post-op. ] [ Designated as safety issue: No ]
CT scans done by an independent core facility will evaluate sternal bone healing with the following parameters:
- Acquire axial images from the lung apices to the costophrenic sulci with the table increment or reconstruction interval equal to or less than the slice thickness. Capture the entire sternum. Slice thickness along the sternum should be at a high spatial resolution thru thin, contiguous image slices (0.8 - 0.9mm). Region scans superior and inferior to the sternum may be made at more customary image slices (3-10 mm) at investigator discretion. CT scans should be taken without contrast.
- All scans should be obtained in the same suspended state of respiration when possible. Scans should be obtained thru the entire area of interest. The field of view should be optimized for each patient.
- Do not use gantry tilt in scanning patients if possible.
- Archive the entire study, preferably in DICOM format, to a removable medium.
Secondary Outcome Measures:
- Pain [ Time Frame: Baseline, Post-Op hospital stay, 3-week, 6-week, 3-month and 6-month ] [ Designated as safety issue: No ]
Intensity and frequency of sternal pain will be assessed using 10 point scales in the following circumstances:
- At rest
- After 10 breaths
- After ambulation
- After forced coughing
Participants will be assessed for pain pre-op (baseline); for the duration of the hospital stay, an expected average of 5 days; at 3-week post-op; 6-week post-op; 3-month post-op and 6-month post-op.
Other Outcome Measures:
- Narcotic Usage [ Time Frame: Baseline, Surgery, ICU stay, Genarl Floor Stay, Discharge, 3-week, 6-week, 3-month and 6-month ] [ Designated as safety issue: No ]Pain medication usage will be tabulated and recorded at each follow-up interval.
| Estimated Enrollment: | 236 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.).
|
Device: Suture Wire
Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
|
|
Experimental: SternaLock Blu 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.
|
Device: SternaLock Blue closure system
SternaLock Blue closure system is a primary closure system plate-based
Other Name: SternaLock, SternalBlu
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783483
Contacts
| Contact: Brian Hatcher, PhD | 904-741-9442 | brian.hatcher@biomet.com |
Locations
| United States, Missouri | |
| Saint Luke's Mid America Heart and Vascular Institute | Recruiting |
| Kansas City, Missouri, United States, 64111 | |
| Contact: Brent Buckman, RN bbuckman@saint-lukes.org | |
| Principal Investigator: Keith B Allen, M.D. | |
| United States, New York | |
| Columbia University Medical Center | Active, not recruiting |
| New York City, New York, United States, 10032 | |
| United States, Texas | |
| Scott & White Memorial Hospital | Active, not recruiting |
| Temple, Texas, United States, 76508 | |
Sponsors and Collaborators
Biomet, Inc.
Investigators
| Principal Investigator: | Keith B Allen, M.D. | St Luke's Mid America and Vascular Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT01783483 History of Changes |
| Other Study ID Numbers: | 0712, SLBlu |
| Study First Received: | January 31, 2013 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biomet, Inc.:
|
CABG Valve replacement sternal closure midline sternotomy sternal plates |
Additional relevant MeSH terms:
|
Angina Pectoris Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 19, 2013