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Bone Hemostat

Experimental: Montage Bone Hemostat for Spinal Fusion

N/A
Waitlist Available
Led By William Lavelle, MD
Research Sponsored by Abyrx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-year and 2-years post surgery
Awards & highlights

Study Summary

This trial looks at whether using MONTAGE Settable Resorbable Hemostatic Bone Putty during surgery reduces postoperative bleeding compared to not using it.

Eligible Conditions
  • Spinal Fusion
  • Ankylosing Spondylitis
  • Scoliosis
  • Kyphosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-year and 2-years post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year and 2-years post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemostasis
Secondary outcome measures
PSO Stability

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Montage Bone HemostatExperimental Treatment1 Intervention
Use of Montage Settable Resorbable Hemostatic bone putty on the cut surfaces of bleeding bone at the osteotomy site
Group II: Standard of Care: No bone hemostatActive Control1 Intervention
Use of no bone hemostat on the cut surfaces of bleeding bone at the osteotomy site

Find a Location

Who is running the clinical trial?

Abyrx, Inc.Lead Sponsor
1 Previous Clinical Trials
65 Total Patients Enrolled
William Lavelle, MDPrincipal InvestigatorSUNY Upstate
1 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
SpineJournal
Comparison of Smith-petersen Osteotomy and Pedicle Subtraction Osteotomy for the Correction of Thoracolumbar Kyphotic Deformity in Ankylosing Spondylitis
Liu, Hui, Changsheng Yang, Zhaomin Zheng, Wenbin Ding, Jianru Wang, Hua Wang, and Sibei Li. 2015. “Comparison of Smith-petersen Osteotomy and Pedicle Subtraction Osteotomy for the Correction of Thoracolumbar Kyphotic Deformity in Ankylosing Spondylitis”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/brs.0000000000000815.
European Spine JournalJournal
Clinical and Radiological Outcomes of Lumbar Posterior Subtraction Osteotomies Are Correlated to Pelvic Incidence and FBI Index
Cogniet, A., S. Aunoble, J. Rigal, H. Demezon, R. Sadikki, and J. C. Le Huec. 2016. “Clinical and Radiological Outcomes of Lumbar Posterior Subtraction Osteotomies Are Correlated to Pelvic Incidence and FBI Index”. European Spine Journal. Springer Science and Business Media LLC. doi:10.1007/s00586-016-4424-5.
Plastic and Reconstructive SurgeryJournal
Outcomes of Calvarial Reconstruction in Cancer Patients
Lee, Edward I., Albert H. Chao, Roman J. Skoracki, Peirong Yu, Franco DeMonte, and Matthew M. Hanasono. 2014. “Outcomes of Calvarial Reconstruction in Cancer Patients”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.prs.0000438061.46290.33.
European Journal of Cardio-Thoracic SurgeryJournal
Primary Closure of Median Sternotomy with Interposition of Hydroxyapatite Blocks A New Approach in Pediatric Cardiac Surgery
BAUMGART, D, G HERBON, A BOROWSKI, and E DEVIVIE. 1991. “Primary Closure of Median Sternotomy with Interposition of Hydroxyapatite Blocks A New Approach in Pediatric Cardiac Surgery”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1016/1010-7940(91)90057-q.
~1 spots leftby Apr 2025
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