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

Part of paid clinical trials in Naples, Florida.

Sponsor
Abyrx, Inc.
Study ID
NCT07215546
Status
Enrolling By Invitation

Conditions

  • Cerclage
  • Pain Management
  • Retrospective Review

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2025
Completion
Apr 30, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Control
    Standard sternal cerclage closure with no settable putty applied in the timeframe (less than one year) immediately preceding use of the test device or concurrently.
  • Arm: Montage or Montage CT
    Standard sternal cerclage closure (typically a minimum of 6 single loop closures) with application of Montage or Montage-CT Settable Resorbable Bone Putty to the cut sternal edge at the time of closure.

Primary Outcome Measure

Cumulative Opiod Dose [ Time Frame: From admission until end of treatment/discharge, up to 8 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
NCH Rooney Heart InstituteNaplesFlorida34102-
Washington UniversitySt LouisMissouri63110-

Find similar trials in Naples, FL

By research site
NCH Rooney Heart Institute· Naples, FLWashington University· St Louis, MO

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