Montage-Enhanced Sternal Closure

University of Calgary

Status and phase: Unknown; Phase 2

Conditions: Sternal Closure

Treatments: Device: Montage bone putty; Other: Conventional Sternal Closure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03365843

REB17-1399

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups

Montage bone putty

Experimental group

Description:

Sternal closure with conventional wire cerclage plus Montage bone putty

Treatment:

Other: Conventional Sternal Closure

Device: Montage bone putty

Conventional Sternal Closure

Active Comparator group

Description:

Conventional wire cerclage sternal closure only -- standard care.

Treatment:

Other: Conventional Sternal Closure