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

Abyrx

Status: Invitation-only

Conditions: Cerclage; Pain Management; Retrospective Review

Treatments: Device: Montage or Montage CT

Study type: Observational

Funder types: Industry

Identifiers

NCT07215546

Abyrx PMRCT 25-002

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Recent CPR.
2. Previous cardiac surgery (redo sternotomy).
3. Emergency surgery (operative intervention within 24 hrs of assessment).
4. Chronic lung disease.
5. BMI > 40.
6. Use of sternal plate systems for closure.
7. Recent antiplatelet therapy.
8. Previous radiotherapy to the chest; receiving immunosuppressive therapy or have a current immunosuppressive condition.
9. Active systemic infection (.i.e: endocarditis).
10. Cognitive impairment (confusion, dementia, Alzheimers, current substance abuse).
11. History of malignancies within past year (except squamous or basal cell carcinoma of the skin that has been treated; no recurrence)
12. Recent history of drug or alcohol abuse.
13. Females who are pregnant, nursing or of childbearing potential who are not practicing a birth control method with high reliability.
14. Postsurgical life expectancy < 90 days in the opinion of the investigator.

14. 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)

Trial design

150 participants in 2 patient groups

Control

Description:

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.

Montage or Montage CT

Description:

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.

Treatment:

Device: Montage or Montage CT