Sternal ClosurePhase 2NCT03365843
Montage-Enhanced Sternal Closure
A Phase 2 study testing Montage bone putty and Conventional Sternal Closure in people with Sternal Closure, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Sternal Closure
- What is being tested?
- Montage bone putty and Conventional Sternal Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2018to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recent CPR
- previous cardiac surgery
- emergency surgery ( within 24 hrs of assessment)
- chronic lung disease
- history of bleeding disorder
- currently taking Vitamin E supplements
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Sternal Closure
- Being tested
- Montage bone putty, Conventional Sternal Closure
- Keywords
- Cardiac surgery, Sternal closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montage bone puttyDevice
Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.
Conventional Sternal ClosureOther
Closure of sternum with standard wire cerclage.
| Study group | Role | What they receive |
|---|---|---|
| Montage bone putty | Experimental | Sternal closure with conventional wire cerclage plus Montage bone putty Receives: Device: Montage bone putty; Other: Conventional Sternal Closure |
| Conventional Sternal Closure | Active comparator | Conventional wire cerclage sternal closure only -- standard care. Receives: Other: Conventional Sternal Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intervention to 6 weeks post-operative
Radiographic Sternal Integrity
No radiographic evidence of bony instability as assessed through serial chest x-rays
Measured: 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.
Measured: Intervention to 12 months post-operative
Secondary outcomes (6)
Post-operative Pain Assessment
Severity of post-operative pain (survey score and analgesic use) comparing treatment vs control groups
Measured: 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
Measured: 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
Measured: Baseline to 12 months post-operative
Sternal Wound Infections
Frequency of sternal wound infections (superficial and deep) between groups
Measured: Baseline to 12 months post-operative
Pulmonary Complications
Post-operative pulmonary complications between groups
Measured: Baseline to 6 weeks post-operative
Health Services resource usage
To compare the burden of health services resource usage between groups (total cost estimate)
Measured: Baseline to 12 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Oct 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sternal ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single centre, double-blind clinical study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Abyrx, Inc.
- Responsible party
- Principal investigator, Dr. Paul Fedak, University of Calgary
- Investigators
- Paul WM Fedak, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365843
- Sponsor's protocol ID
- REB17-1399
- Status last verified
- Sep 2021
- First submitted
- 26 Oct 2017
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36272766
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montage- Enhanced Sternal Closure to Accelerate Post-Operative Recovery
- ClinicalTrials.gov ID
- NCT03365843
- Acronym / sponsor ID
- REB17-1399
- Conditions
- Sternal Closure
- Keywords
- Cardiac surgery, Sternal closure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Abyrx, Inc.
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single centre, double-blind clinical study
| Arm | Type | Receives |
|---|---|---|
| Montage bone putty | Experimental | Device: Montage bone putty, Other: Conventional Sternal ClosureSternal closure with conventional wire cerclage plus Montage bone putty |
| Conventional Sternal Closure | Active comparator | Other: Conventional Sternal ClosureConventional wire cerclage sternal closure only -- standard care. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- Recent CPR
- previous cardiac surgery
- emergency surgery ( within 24 hrs of assessment)
- chronic lung disease
- history of bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Montage bone puttyApplication of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery. | Device | Montage bone putty |
| Conventional Sternal ClosureClosure of sternum with standard wire cerclage. | Other | Conventional Sternal Closure, Montage bone putty |
Primary outcome
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.
6 secondary outcomes
Post-operative Pain Assessment
Time frame: Baseline to 12 months post - operative.
Rate of post-operative recovery
Time frame: Baseline to 12 months post-operative
Rate of post-operative recovery
Time frame: Baseline to 12 months post-operative
Sternal Wound Infections
Time frame: Baseline to 12 months post-operative
Pulmonary Complications
Time frame: Baseline to 6 weeks post-operative
Health Services resource usage
Time frame: Baseline to 12 months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 36272766Vasanthan 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.
- Individual participant dataSharing planned: No
Related trials for Sternal Closure
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Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
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Not yet recruiting
Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
Sternotomy Closure,Open Heart Surgery
Enrolling by invitationObservational study
Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy
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Active, not recruiting
RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy
Median Sternotomy
Active, not recruitingObservational study
Sternal Closure in High-BMI Patients: Cable vs Wire
Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul WM Fedak, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Montage bone putty and Conventional Sternal Closure in people with Sternal Closure, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of Respiratory Function (time frame: Intervention to 6 weeks post-operative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.