Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy
NCT ID: NCT04125147
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2019-12-05
2023-07-20
Brief Summary
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Detailed Description
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PSO typically results in substantial loss of blood (as much as 2L) with a significant portion of the loss likely occurring at the osteotomy surfaces post-surgically. The control of peri-operative blood loss is considered a critical issue by spine surgeons. A variety of methods have been proposed for the reduction of blood loss during or immediately after spine surgery, including preoperative use of erythropoietin, autologous blood, cell salvage, intra-operative controlled hypotension, and the use of anti-fibrinolytic drugs. Bone hemostats have traditionally not been part of the standard of care to promote hemostasis probably because most traditional options (e.g., bone wax) are nonabsorbable and thus might interfere with fusion at the osteotomy site.
MONTAGE is a settable (hardening) bioabsorbable polymer and hydroxyapatite/beta tricalcium phosphate based putty, used in the control of bleeding from bone during spine, orthopedic, craniomaxillofacial, thoracic and other surgical procedures, and has been FDA cleared.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Montage Bone Hemostat
Use of Montage Settable Resorbable Hemostatic bone putty on the cut surfaces of bleeding bone at the osteotomy site
Experimental: Montage Bone Hemostat
Use of Montage bone hemostat on the cut surfaces of bone at the osteotomy site
Standard of Care: No bone hemostat
Use of no bone hemostat on the cut surfaces of bleeding bone at the osteotomy site
No interventions assigned to this group
Interventions
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Experimental: Montage Bone Hemostat
Use of Montage bone hemostat on the cut surfaces of bone at the osteotomy site
Eligibility Criteria
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Inclusion Criteria
* Non-smokers (have proven to quit smoking for at least 6 months prior to surgery) and current smokers.
* Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence). A pregnancy test at the Week 0 visit must be administered, and must be negative, for inclusion into the study.
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Abyrx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Lavelle, MD
Role: PRINCIPAL_INVESTIGATOR
SUNY Upstate
Locations
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Upstate Medical University
Syracuse, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Baumgart D, Herbon G, Borowski A, de Vivie ER. Primary closure of median sternotomy with interposition of hydroxyapatite blocks. A new approach in pediatric cardiac surgery. Eur J Cardiothorac Surg. 1991;5(7):383-5. doi: 10.1016/1010-7940(91)90057-q.
Barbanti Brodano G, Griffoni C, Zanotti B, Gasbarrini A, Bandiera S, Ghermandi R, Boriani S. A post-market surveillance analysis of the safety of hydroxyapatite-derived products as bone graft extenders or substitutes for spine fusion. Eur Rev Med Pharmacol Sci. 2015 Oct;19(19):3548-55.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20182341
Identifier Type: -
Identifier Source: org_study_id
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