NCT07215546

Enhanced Sternal Closure With Montage or Montage-CT to Evaluate Post-Operative Opioid Use Following Median Sternotomy

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Abyrx, Inc. · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a retrospective study based on analysis real world data obtained from hospitals that have adopted use of Montage or Montage-CT for use following sternotomy. The analysis will report the post-operative use of analgesic medication (including opioids) and compare the use against a control group consisting of patients operated by the same surgeon concurrently or prior to adoption of Montage or Montage-CT for use in sternotomy closure.

Conditions

• Retrospective Review
• Cerclage
• Pain Management

Interventions

Type	Name	Description
DEVICE	Montage or Montage CT	Application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure.

Timeline

• Start date: 2025-10-01
• Primary completion: 2025-12-01
• Completion: 2026-04-01
• First posted: 2025-10-10
• Last updated: 2025-10-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study