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Montage bone putty for Sternal Closure
Phase 2
Waitlist Available
Led By Paul WM Fedak, MD, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months post-operative
Awards & highlights
No Placebo-Only Group
Summary
This study is evaluating whether a technique to enhance sternal stability after cardiac surgery can improve recovery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 months post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months post-operative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Radiographic Sternal Integrity
Recovery of Respiratory Function
Sternal Revision
Secondary study objectives
Health Services resource usage
Post-operative Pain Assessment
Pulmonary Complications
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Montage bone puttyExperimental Treatment2 Interventions
Sternal closure with conventional wire cerclage plus Montage bone putty
Group II: Conventional Sternal ClosureActive Control1 Intervention
Conventional wire cerclage sternal closure only -- standard care.
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Who is running the clinical trial?
University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,749 Total Patients Enrolled
Abyrx, Inc.Industry Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Paul WM Fedak, MD, PhDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
8 Total Patients Enrolled
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