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

Primary Purpose

Fused Vertebrae, Ankylosing Spondylitis, Sagittal Deformities

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Experimental: Montage Bone Hemostat

About this trial

This is an interventional treatment trial for Fused Vertebrae

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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 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.

Sites / Locations

Upstate Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Montage Bone Hemostat

Standard of Care: No bone hemostat

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Hemostasis

Secondary Outcome Measures

PSO Stability

The secondary objective is the stability of the construct, as measured by whether the correction has maintained stability at 1-year and 2-years post surgery. Each incidence of instability will be categorized as belonging to one of the following groups: 1) hardware malplacement, 2) loosening or dislodgement, 3) nonunion or nonfusion with hardware fracture 4) nonunion or nonfusion without hardware fracture and 5) perihardware fracture.

Full Information

NCT ID

NCT04125147

First Posted

October 9, 2019

Last Updated

July 28, 2023

Sponsor

Abyrx, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04125147

Brief Title

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

Official Title

A Prospective, Multicenter, Randomized, Controlled Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Terminated

Why Stopped

Low enrollment

Study Start Date

December 5, 2019 (Actual)

Primary Completion Date

July 20, 2023 (Actual)

Study Completion Date

July 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abyrx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

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.

Detailed Description

Pedicle Subtraction osteotomy (PSO) is a surgical option for treating several spinal deformities. It has been utilized in alignment disorders of the fused spine, in the lumbar spine to treat large sagittal deformities and in patients with ankylosing spondylitis with thoracolumbar kyphotic deformity. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fused Vertebrae, Ankylosing Spondylitis, Sagittal Deformities, Thoracolumbar Kyphosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Montage Bone Hemostat

Arm Type

Experimental

Arm Description

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

Arm Title

Standard of Care: No bone hemostat

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Experimental: Montage Bone Hemostat

Intervention Description

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

Primary Outcome Measure Information:

Title

Hemostasis

Description

Time Frame

Week 0

Title

Hemostasis

Description

Time Frame

Week 0

Title

Hemostasis

Description

Time Frame

Week 0

Secondary Outcome Measure Information:

Title

PSO Stability

Description

Time Frame

1-year and 2-years post surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Lavelle, MD

Organizational Affiliation

SUNY Upstate

Official's Role

Principal Investigator

Facility Information:

Facility Name

Upstate Medical University

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26861730

Citation

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.

Results Reference

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PubMed Identifier

25868095

Citation

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.

Results Reference

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PubMed Identifier

16946635

Citation

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.

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PubMed Identifier

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Citation

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.

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

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