Montage-Enhanced Sternal Closure
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|ClinicalTrials.gov Identifier: NCT03365843|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Sternal Closure||Device: Montage bone putty Other: Conventional Sternal Closure||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, single centre, double-blind clinical study|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
- Recovery of Respiratory Function [ Time Frame: Intervention to 6 weeks post-operative ]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.
- Radiographic Sternal Integrity [ Time Frame: Intervention to 12 months post-operative ]No radiographic evidence of bony instability as assessed through serial chest x-rays
- Sternal Revision [ Time Frame: Intervention to 12 months post-operative ]Absence of device (wire or Montage bone putty) removal, revision or reoperation occurring over first 12 months post-operative.
- Post-operative Pain Assessment [ Time Frame: Baseline to 12 months post - operative. ]Severity of post-operative pain (survey score and analgesic use) comparing treatment vs control groups
- Rate of post-operative recovery [ Time Frame: Baseline to 12 months post-operative ]Rate of post-operative recovery as measured by health related quality of life (EQ5D) standardized assessment tool
- Rate of post-operative recovery [ Time Frame: Baseline to 12 months post-operative ]Rate of post-operative recovery as measured by physical functioning (HAQ) standardized assessment tool
- Sternal Wound Infections [ Time Frame: Baseline to 12 months post-operative ]Frequency of sternal wound infections (superficial and deep) between groups
- Pulmonary Complications [ Time Frame: Baseline to 6 weeks post-operative ]Post-operative pulmonary complications between groups
- Health Services resource usage [ Time Frame: Baseline to 12 months post-operative ]To compare the burden of health services resource usage between groups (total cost estimate)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365843
|Contact: Paul WM Fedak, MD, PhDfirstname.lastname@example.org|
|University of Calgary|
|Calgary, Alberta, Canada, T2N 2T9|
|Principal Investigator:||Paul WM Fedak, MD, PhD||University of Calgary|