Montage-Enhanced Sternal Closure

NCT03365843 | Unknown Phase 2 DMC

• 1 other identifier: REB17-1399
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Sternal Closure

Keywords

Cardiac surgery; Sternal closure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Post-operative Pain Assessment

  Baseline to 12 months post - operative.

• Rate of post-operative recovery

  Baseline to 12 months post-operative

• Rate of post-operative recovery

  Baseline to 12 months post-operative

• Sternal Wound Infections

  Baseline to 12 months post-operative

• Pulmonary Complications

  Baseline to 6 weeks post-operative

Study Arms (2)

Montage bone putty

EXPERIMENTAL

Sternal closure with conventional wire cerclage plus Montage bone putty

Device: Montage bone putty; Other: Conventional Sternal Closure

Conventional Sternal Closure

ACTIVE COMPARATOR

Conventional wire cerclage sternal closure only -- standard care.

Other: Conventional Sternal Closure

Interventions

Montage bone putty DEVICE

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

Montage bone putty

Conventional Sternal Closure OTHER

Closure of sternum with standard wire cerclage.

Conventional Sternal Closure; Montage bone putty

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Abyrx, Inc.: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (1)

• Vasanthan V, Fatehi Hassanabad A, Kang S, Dundas J, Ramadan D, Holloway D, Adams C, Ahsan M, Fedak PWM. Novel hardening bone putty enhances sternal closure and accelerates postoperative recovery. J Thorac Cardiovasc Surg. 2023 Nov;166(5):e430-e443. doi: 10.1016/j.jtcvs.2022.09.016. Epub 2022 Sep 17.

  PMID: 36272766 DERIVED

Study Officials

• Paul WM Fedak, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Cardiac Surgeon

Model Details: Randomized, single centre, double-blind clinical study

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: December 7, 2017
• Study Start: October 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)