Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy

NCT04125147 | Terminated FDA Device

• 1 other identifier: 20182341
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy procedures.

Conditions

Fused Vertebrae; Ankylosing Spondylitis; Sagittal Deformities; Thoracolumbar Kyphosis

Outcome Measures

Primary Outcomes (3)

• Hemostasis

  The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat), and the extent to which any transfusion is needed.

  Week 0

• Hemostasis

  The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat), with blood loss is measured through drop in hematocrit (HCT).

  Week 0

• Hemostasis

  The primary objective of this study is to evaluate the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE and standard of care (no bone hemostat) as wound drain output, if utilized.

  Week 0

Secondary Outcomes (1)

• PSO Stability

  1-year and 2-years post surgery

Study Arms (2)

Montage Bone Hemostat

EXPERIMENTAL

Use of Montage Settable Resorbable Hemostatic bone putty on the cut surfaces of bleeding bone at the osteotomy site

Device: Experimental: Montage Bone Hemostat

Standard of Care: No bone hemostat

NO INTERVENTION

Use of no bone hemostat on the cut surfaces of bleeding bone at the osteotomy site

Interventions

Experimental: Montage Bone Hemostat DEVICE

Use of Montage bone hemostat on the cut surfaces of bone at the osteotomy site

Montage Bone Hemostat

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of spinal deformity requiring a PSO at a single site level, such as for patients with thoracolumbar kyphotic deformity, sagittal imbalance, and spinal global malalignment.
• Non-smokers (have proven to quit smoking for at least 6 months prior to surgery) and current smokers.
• Subject understands and is willing to participate in the clinical study and can comply with required visits and the follow-up regimen.
• Subject has read and signed the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form before screening procedures are undertaken.

You may not qualify if:

• Subjects whose spinal deformity is deemed by the investigator to be of such severity that a possible surgical intervention would be either harmful or not warranted.
• Subjects with morbid obesity (i.e. a Body Mass Index \[BMI\] ≥ 40).
• Subjects who have a known allergy to the components of MONTAGE.
• Subjects who are non-mobile (i.e. not ambulatory, or have significant impairment of their mobility making them completely bedridden).
• Subjects who, in the opinion of the investigator, show evidence of infection, cellulitis, and/or osteomyelitis.
• Subjects with abnormally low platelets, abnormal coagulation parameters, or with documented bleeding disorders, including a prior history of excessive bleeding during surgery.
• Subjects with a history of a malignancy, not in remission for five years or more, or a newly diagnosed malignancy, treated with cytotoxic therapies or radiation therapy.
• Subjects on any investigational drug(s) within 30 days preceding randomization (i.e. Week 0); or subject or physician anticipates use of any of these therapies by the subject during the course of the study.
• Subjects with:
• (i) Alcohol abuse as recorded by an average daily intake of \> 4 units in females, \> 5 units in males (i.e. 1 oz. of spirit, glass of wine, or can of beer per unit).
• (ii) Drug abuse as evidenced by the subject's use of illegal drugs or prescription drugs that have not been prescribed for him/her.
• Subjects with one or more medical conditions, as determined by medical history, including renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study.
• Subjects with a history of osteoporosis, as defined by imaging, or on medication for osteoporosis or documented fracture of fragility (Hip fracture, osteoporotic compression fracture, distal radius fracture). If there are any concerns these may be arbitrated by the study PI.
• Subject has previously participated in any MONTAGE trial.
• Subjects who are unable to understand the aims and objectives of the trial and/or unwilling to return for the follow-up examinations.

Sponsors & Collaborators

• Abyrx, Inc.: lead

Study Sites (1)

Upstate Medical University

Syracuse, New York, 13210, United States

Location

Related Publications (12)

• Cogniet A, Aunoble S, Rigal J, Demezon H, Sadikki R, Le Huec JC. Clinical and radiological outcomes of lumbar posterior subtraction osteotomies are correlated to pelvic incidence and FBI index : Prospective series of 63 cases. Eur Spine J. 2016 Aug;25(8):2657-67. doi: 10.1007/s00586-016-4424-5. Epub 2016 Feb 10.

  PMID: 26861730 BACKGROUND

• Liu H, Yang C, Zheng Z, Ding W, Wang J, Wang H, Li S. Comparison of Smith-Petersen osteotomy and pedicle subtraction osteotomy for the correction of thoracolumbar kyphotic deformity in ankylosing spondylitis: a systematic review and meta-analysis. Spine (Phila Pa 1976). 2015 Apr 15;40(8):570-9. doi: 10.1097/BRS.0000000000000815.

  PMID: 25868095 BACKGROUND

• Bridwell KH. Decision making regarding Smith-Petersen vs. pedicle subtraction osteotomy vs. vertebral column resection for spinal deformity. Spine (Phila Pa 1976). 2006 Sep 1;31(19 Suppl):S171-8. doi: 10.1097/01.brs.0000231963.72810.38.

  PMID: 16946635 BACKGROUND

• Bridwell KH, Lewis SJ, Lenke LG, Baldus C, Blanke K. Pedicle subtraction osteotomy for the treatment of fixed sagittal imbalance. J Bone Joint Surg Am. 2003 Mar;85(3):454-63. doi: 10.2106/00004623-200303000-00009.

  PMID: 12637431 BACKGROUND

• Hyun SJ, Kim YJ, Rhim SC. Spinal pedicle subtraction osteotomy for fixed sagittal imbalance patients. World J Clin Cases. 2013 Nov 16;1(8):242-8. doi: 10.12998/wjcc.v1.i8.242.

  PMID: 24340276 BACKGROUND

• Lee EI, Chao AH, Skoracki RJ, Yu P, DeMonte F, Hanasono MM. Outcomes of calvarial reconstruction in cancer patients. Plast Reconstr Surg. 2014 Mar;133(3):675-682. doi: 10.1097/01.prs.0000438061.46290.33.

  PMID: 24263391 BACKGROUND

• Cheng L, Ye F, Yang R, Lu X, Shi Y, Li L, Fan H, Bu H. Osteoinduction of hydroxyapatite/beta-tricalcium phosphate bioceramics in mice with a fractured fibula. Acta Biomater. 2010 Apr;6(4):1569-74. doi: 10.1016/j.actbio.2009.10.050. Epub 2009 Nov 5.

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• Pripatnanont P, Praserttham P, Suttapreyasri S, Leepong N, Monmaturapoj N. Bone Regeneration Potential of Biphasic Nanocalcium Phosphate with High Hydroxyapatite/Tricalcium Phosphate Ratios in Rabbit Calvarial Defects. Int J Oral Maxillofac Implants. 2016 Mar-Apr;31(2):294-303. doi: 10.11607/jomi.4531.

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• Koshiyama H, Yamazaki K. Absorbable sternal pins improve sternal closure stability within a small deviation. Gen Thorac Cardiovasc Surg. 2015 Jun;63(6):331-4. doi: 10.1007/s11748-015-0533-z. Epub 2015 Feb 27.

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  PMID: 26502842 BACKGROUND

• Yi S, Rim DC, Park SW, Murovic JA, Lim J, Park J. Biomechanical Comparisons of Pull Out Strengths After Pedicle Screw Augmentation with Hydroxyapatite, Calcium Phosphate, or Polymethylmethacrylate in the Cadaveric Spine. World Neurosurg. 2015 Jun;83(6):976-81. doi: 10.1016/j.wneu.2015.01.056. Epub 2015 Mar 10.

  PMID: 25769482 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• William Lavelle, MD

  SUNY Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 14, 2019
• Study Start: December 5, 2019
• Primary Completion: July 20, 2023
• Study Completion: July 20, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)