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Retrospective ReviewNCT07215546

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

An observational study of Retrospective Review and Cerclage, run by Abyrx, Inc. at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 80 years
Conditions the study is for
Retrospective Review, Cerclage, Pain Management
What is being tested?
Montage or Montage CT
Type of treatment
Medical device
How many people
150 participants
Where
2 sitesUnited States
Study dates
Oct 2025to Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.
  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • NCH Rooney Heart Institute

    Naples, Florida, 34102

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Being tested
Montage or Montage CT
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Montage or Montage CTDevice

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

Study groups in NCT07215546
Study groupRoleWhat they receive
ControlStandard 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 CTStandard 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.
Receives: Device: Montage or Montage CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)

  1. Time to Discharge

    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.

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

  2. Time to Opioid Cessation

    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.

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

  3. Percent Discharged with Opioid Prescription

    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.

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

  4. Percent without Opioid Use

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study startOct 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215546
Sponsor's protocol ID
Abyrx PMRCT 25-002
Status last verified
Oct 2025
First submitted
25 Sep 2025
Last updated
10 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 12457323

  • 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.

    PubMed 11576043

  • 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.

    PubMed 11576042

  • 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.

    PubMed 33930358

  • 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.

    PubMed 32584934

  • 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.

    PubMed 14500232

  • Losanoff JE, Jones JW, Richman BW. Primary closure of median sternotomy: techniques and principles. Cardiovasc Surg. 2002 Apr;10(2):102-10. doi: 10.1177/096721090201000203.

    PubMed 11888737

  • 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.

    PubMed 10343263

  • 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.

    PubMed 25882356

Questions about this trial

What is this clinical trial studying?

An observational study of Retrospective Review and Cerclage, run by Abyrx, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Opiod Dose (time frame: From admission until end of treatment/discharge, up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07215546, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.

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