Montage-Enhanced Sternal Closure

Study Overview
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Brief Summary
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Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless steel wires. Augmenting sternal closure with techniques to enhance early bone stability should accelerate functional recovery from cardiac surgery thereby reducing post-operative pain, decreasing the need for narcotics, improving breathing and chest wall mechanics, stimulating early mobility and expediting hospital discharge. This study is a randomized, single-centre, double-blind clinical study comparing the effects of Montage bone putty plus conventional wire closure vs conventional wire closure only on the post-operative recovery of cardiac surgery patients with full medial sternotomy.

Detailed Description
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Patients undergoing cardiac surgery who are participating in the study will be randomized to either conventional wire cerclage or conventional wire closure plus the use of Montage bone putty. Patients will be followed post-operatively Day 3, 5 and at discharge as well as weeks 2, 4, 6 and months 3, 6 and 12. Each visit will include: Pain assessment, wound assessment, sternal assessment, analgesic/antibiotic use, spirometry testing, quality of life questionaries (EQ-5D/HAQ) and determination of any adverse events. Chest x-rays will done at discharge and 3, 6, and 12 months to look at sternal healing. This pilot study will include a total of 65 patient (40 conventional + putty / 20 conventional/ 5 initial open label with putty).

Official Title
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Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery

Conditions
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Sternal Closure

Intervention / Treatment
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* Device: Montage bone putty
* Other: Conventional Sternal Closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing non-emergent cardiac surgery ( cabg only or one valve procedure) full median sternotomy approach, with or without cardiopulmonary bypass English speaking geographically accessible written consent Exclusion Criteria: Recent CPR previous cardiac surgery emergency surgery ( within 24 hrs of assessment) chronic lung disease history of bleeding disorder currently taking Vitamin E supplements recent antiplatelet therapy excessively poor baseline health-related quality of life or physical functioning previous radiotherapy to chest, or on immunosuppressive drugs or current immunosuppressive condition active significant systemic infection, history of recurrent infections, cognitive impairment ( confusion, dementia, Alzheimer's, current substance abuse) history of malignancy within the past year recent history of significant alcohol or drug abuse females who are pregnant, nursing, or child bearing potential who are not practicing a highly reliable birth control method postsurgical life expectancy of less than 90 days moderate to severe pectus deformity participation in another study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, single centre, double-blind clinical study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montage bone putty<br>Sternal closure with conventional wire cerclage plus Montage bone putty | Device: Montage bone putty<br>* Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.<br>Other: Conventional Sternal Closure<br>* Closure of sternum with standard wire cerclage.<br>|
| Active Comparator: Conventional Sternal Closure<br>Conventional wire cerclage sternal closure only -- standard care. | Other: Conventional Sternal Closure<br>* Closure of sternum with standard wire cerclage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of Respiratory Function | The recovery of pulmonary functional capacity as measured by the return of forced vital capacity (FVC) to 80% or greater of the pre-operative baseline FVC measurement. | Intervention to 6 weeks post-operative | 
| Radiographic Sternal Integrity | No radiographic evidence of bony instability as assessed through serial chest x-rays | Intervention to 12 months post-operative | 
| Sternal Revision | Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative. | Intervention to 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pain Assessment | Severity of post-operative pain (survey score and analgesic use) comparing treatment vs control groups | Baseline to 12 months post - operative. | 
| Rate of post-operative recovery | Rate of post-operative recovery as measured by health related quality of life (EQ5D) standardized assessment tool | Baseline to 12 months post-operative | 
| Rate of post-operative recovery | Rate of post-operative recovery as measured by physical functioning (HAQ) standardized assessment tool | Baseline to 12 months post-operative | 
| Sternal Wound Infections | Frequency of sternal wound infections (superficial and deep) between groups | Baseline to 12 months post-operative | 
| Pulmonary Complications | Post-operative pulmonary complications between groups | Baseline to 6 weeks post-operative | 
| Health Services resource usage | To compare the burden of health services resource usage between groups (total cost estimate) | Baseline to 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Sternal closure