Montage-Enhanced Sternal Closure

Phase 2

Interventions: Other: Conventional Sternal Closure
Device: Montage bone putty

Brief Summary: 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: 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).

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Conventional Sternal Closure	Conventional Sternal Closure	Conventional wire cerclage sternal closure only -- standard care.
Montage bone putty	Conventional Sternal Closure	Sternal closure with conventional wire cerclage plus Montage bone putty
Montage bone putty	Montage bone putty	Sternal closure with conventional wire cerclage plus Montage bone putty

Primary Outcome Measures

Name	Time	Method
Sternal Revision	Intervention to 12 months post-operative	Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative.
Radiographic Sternal Integrity	Intervention to 12 months post-operative	No radiographic evidence of bony instability as assessed through serial chest x-rays
Recovery of Respiratory Function	Intervention to 6 weeks post-operative	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.

Secondary Outcome Measures

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