Montage-Enhanced Sternal Closure

Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sternal Closure
• Intervention / Treatment: Device: Montage bone putty; Other: Conventional Sternal Closure

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).

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Abyrx, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: December 3, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac surgery; Sternal closure
• Other Study ID Numbers: REB17-1399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No