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Enrolling by Invitation

NCT Number: NCT07215546

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

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.

Enrolling by Invitation

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NCH Rooney Heart Institute, Naples, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female > 19 years of age.
  • Underwent non-emergent cardiac surgery (isolated coronary artery by-pass grafting and/or isolated valve surgery).
  • Full median sternotomy approach - with/without cardiopulmonary bypass.

Exclusion criteria

  • Recent CPR.
  • Previous cardiac surgery (redo sternotomy).
  • Emergency surgery (operative intervention within 24 hrs of assessment).
  • Chronic lung disease.
  • BMI > 40.
  • Use of sternal plate systems for closure.
  • Recent antiplatelet therapy.
  • Previous radiotherapy to the chest; receiving immunosuppressive therapy or have a current immunosuppressive condition.
  • Active systemic infection (.i.e: endocarditis).
  • Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse).
  • History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence)
  • Recent history of drug or alcohol abuse.
  • Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability.
  • Postsurgical life expectancy < 90 days in the opinion of the investigator.
  • Moderate or severe pectus deformity. 16. Participation in another clinical trial. 17. Patients who had Patient-Controlled Analgesia (PCA) devices after surgery. 18. Patients who received a local anesthetic treatment and/or device on the sternum intraoperatively during surgery (e.g. On-Q Pain Relief System, Exparel etc)

Treatment and study plan

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.

Primary outcomes

  1. Cumulative Opiod Dose

    Time frame: From admission until end of treatment/discharge, up to 8 weeks

    • Cumulative opioid dose (COD) is measured from entry into the postoperative ICU through the time of achieving hospital discharge criteria. Opioid use will be quantified in morphine equivalents, using conversion factors based on Von Korff, et al.

Secondary outcomes

  1. Time to Discharge

    Time frame: From admission until end of treatment/discharge, up to 8 weeks

    Postoperative time to achieving hospital discharge criteria (TTHDC) measured in hours from entry into the postoperative ICU to the time a patient meets hospital discharge criteria.

  2. Time to Opioid Cessation

    Time frame: From admission until end of treatment/discharge, up to 8 weeks

    Time to opioid cessation (TTOC) measured in hours from entry into the postoperative ICU to the first time point at which a patient achieved a sustained period of at least 24 consecutive hours.

  3. Percent Discharged with Opioid Prescription

    Time frame: From admission until end of treatment/discharge, up to 8 weeks

    Percentage of patients discharged with an opioid prescription (DWOP) based on the number of patients who received a prescription for an opioid medication at hospital discharge.

  4. Percent without Opioid Use

    Time frame: From admission until end of treatment/discharge, up to 8 weeks

    Percentage of patients with no opioid analgesic use (NOU) based on the number of patients who did not receive any opioid medication from entry into the postoperative ICU through the time of achieving hospital discharge criteria.

Sponsors and collaborators

Lead sponsor

Abyrx, Inc.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 10, 2025
Registry last updated
Oct 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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