MedTrace Logo

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

NCT07215546 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-10-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Abyrx, Inc.

    lead INDUSTRY

Principal Investigators

  • Aniq Darr, Ph.D. · Abyrx, Inc.

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2025-12-31
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215546 on ClinicalTrials.gov