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NCT03365843

Montage-Enhanced Sternal Closure

Status unknown Phase 2 Last updated 28 September 2021
What this trial tests

Phase 2 trial testing Montage bone putty in Sternal Closure in 65 participants. Status unknown.

Timeline
1 October 2018
Primary endpoint
1 December 2022
1 December 2022

Quick facts

Lead sponsorUniversity of Calgary
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment65
Start date1 October 2018
Primary completion1 December 2022
Estimated completion1 December 2022
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Calgary

Who can join

Adults 19 to 79, any sex, with Sternal Closure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Novel hardening bone putty enhances sternal closure and accelerates postoperative recovery.
    Vasanthan V, Fatehi Hassanabad A, Kang S, Dundas J, et al · · 2023 · cited 3× · PMID 36272766 · DOI 10.1016/j.jtcvs.2022.09.016

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