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

NCT07215546 | Enrolling By Invitation FDA Device

• 1 other identifier: Abyrx PMRCT 25-002
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cumulative Opiod Dose

  1\. 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.

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

Secondary Outcomes (4)

• Time to Discharge

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

• Time to Opioid Cessation

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

• Percent Discharged with Opioid Prescription

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

• Percent without Opioid Use

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

Study Arms (2)

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.

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.

Device: Montage or Montage CT

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.

Montage or Montage CT

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females age \> 19 years of age who have undergone non-emergent cardiac surgery (coronary artery by-pass grafting \[CABG\] and/or single valve replacement procedure).

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abyrx, Inc.: lead

Study Sites (2)

NCH Rooney Heart Institute

Naples, Florida, 34102, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (9)

• Losanoff JE, Richman BW, Jones JW. Risk analysis of deep sternal wound infection and mediastinitis in cardiac surgery. Thorac Cardiovasc Surg. 2002 Dec;50(6):385. doi: 10.1055/s-2002-35738. No abstract available.

  PMID: 12457323 BACKGROUND

• Meyerson J, Thelin S, Gordh T, Karlsten R. The incidence of chronic post-sternotomy pain after cardiac surgery--a prospective study. Acta Anaesthesiol Scand. 2001 Sep;45(8):940-4. doi: 10.1034/j.1399-6576.2001.450804.x.

  PMID: 11576043 BACKGROUND

• Kalso E, Mennander S, Tasmuth T, Nilsson E. Chronic post-sternotomy pain. Acta Anaesthesiol Scand. 2001 Sep;45(8):935-9. doi: 10.1034/j.1399-6576.2001.450803.x.

  PMID: 11576042 BACKGROUND

• Ingason AB, Geirsson A, Gudbjartsson T, Muehlschlegel JD, Sigurdsson MI. The Incidence of New Persistent Opioid Use Following Cardiac Surgery via Sternotomy. Ann Thorac Surg. 2022 Jan;113(1):33-40. doi: 10.1016/j.athoracsur.2021.04.030. Epub 2021 Apr 27.

  PMID: 33930358 BACKGROUND

• Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445.

  PMID: 32584934 BACKGROUND

• Li AE, Fishman EK. Evaluation of complications after sternotomy using single- and multidetector CT with three-dimensional volume rendering. AJR Am J Roentgenol. 2003 Oct;181(4):1065-70. doi: 10.2214/ajr.181.4.1811065. No abstract available.

  PMID: 14500232 BACKGROUND

• Losanoff JE, Jones JW, Richman BW. Primary closure of median sternotomy: techniques and principles. Cardiovasc Surg. 2002 Apr;10(2):102-10. doi: 10.1016/s0967-2109(01)00128-4.

  PMID: 11888737 BACKGROUND

• McGregor WE, Trumble DR, Magovern JA. Mechanical analysis of midline sternotomy wound closure. J Thorac Cardiovasc Surg. 1999 Jun;117(6):1144-50. doi: 10.1016/s0022-5223(99)70251-5.

  PMID: 10343263 BACKGROUND

• Lemaignen A, Birgand G, Ghodhbane W, Alkhoder S, Lolom I, Belorgey S, Lescure FX, Armand-Lefevre L, Raffoul R, Dilly MP, Nataf P, Lucet JC. Sternal wound infection after cardiac surgery: incidence and risk factors according to clinical presentation. Clin Microbiol Infect. 2015 Jul;21(7):674.e11-8. doi: 10.1016/j.cmi.2015.03.025. Epub 2015 Apr 14.

  PMID: 25882356 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aniq Darr, Ph.D.

  Abyrx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 10, 2025
• Study Start: October 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)