Montage-Enhanced Sternal Closure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-12-01

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.

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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).

Conditions

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Sternal Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, single centre, double-blind clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

The participants, study coordinator and care-givers are blinded to the assigned treatment arm. Participants may be able to guess which treatment group they have been assigned. This will be assessed at the end of the study by asking participants to identify the group to which they think they have been assigned.

Study Groups

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Montage bone putty

Sternal closure with conventional wire cerclage plus Montage bone putty

Group Type EXPERIMENTAL

Montage bone putty

Intervention Type DEVICE

Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.

Conventional Sternal Closure

Intervention Type OTHER

Closure of sternum with standard wire cerclage.

Conventional Sternal Closure

Conventional wire cerclage sternal closure only -- standard care.

Group Type ACTIVE_COMPARATOR

Conventional Sternal Closure

Intervention Type OTHER

Closure of sternum with standard wire cerclage.

Interventions

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Montage bone putty

Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.

Intervention Type DEVICE

Conventional Sternal Closure

Closure of sternum with standard wire cerclage.

Intervention Type OTHER

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No