A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering
NCT ID: NCT04914507
Last Updated: 2023-11-15
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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RECRUITING
NA
106 participants
INTERVENTIONAL
2021-09-09
2029-09-30
Brief Summary
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The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically:
1. The effect on three-dimensional spine growth as compared to normal controls
2. Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
3. Complications associated with both the procedure and the device
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anterior Vertebral Body Tethering
The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete.
Anterior Vertebral Body Tethering
Subject will receive anterior vertebral body tethering surgery.
Interventions
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Anterior Vertebral Body Tethering
Subject will receive anterior vertebral body tethering surgery.
Eligibility Criteria
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Inclusion Criteria
* Planned recipient of AVBT surgical treatment
* Skeletally immature
* Major Cobb angle ≥30° and ≤65°
* Osseous structure dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging
* Failed or intolerant to bracing
Exclusion Criteria
* Prior spinal surgery at the level(s) to be treated
* Evidence of documented poor bone quality
* Any other medical or surgical condition which would preclude the potential benefit of spinal surgery, such as coagulation disorders, allergies to the implant materials, and patient's unwillingness or inability to cooperate with post-operative care instructions as determined by the treating physician
* Unwillingness, inability, or living situation (e.g. custody arrangements, homelessness, detention) that would preclude ability to return to the study site for follow-up visits as described in protocol and Informed Consent
* Unwillingness to sign Informed Consent Form and participate in study procedures
18 Years
ALL
No
Sponsors
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Pediatric Spine Foundation
OTHER
Responsible Party
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Principal Investigators
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Ron El-Hawary, MD
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Locations
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Children's National Hospital
Washington D.C., District of Columbia, United States
Shriners Children's Chicago
Chicago, Illinois, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
Morgan Stanley Childrens Hospital of New York-Presbyterian
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Shriners Children's Portland
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University
Nashville, Tennessee, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Countries
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Central Contacts
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References
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Coghlan RF, Oberdorf JA, Sienko S, Aiona MD, Boston BA, Connelly KJ, Bahney C, LaRouche J, Almubarak SM, Coleman DT, Girkontaite I, von der Mark K, Lunstrum GP, Horton WA. A degradation fragment of type X collagen is a real-time marker for bone growth velocity. Sci Transl Med. 2017 Dec 6;9(419):eaan4669. doi: 10.1126/scitranslmed.aan4669.
Trobisch P, Suess O, Schwab F. Idiopathic scoliosis. Dtsch Arztebl Int. 2010 Dec;107(49):875-83; quiz 884. doi: 10.3238/arztebl.2010.0875. Epub 2010 Dec 10.
Karol LA, Johnston C, Mladenov K, Schochet P, Walters P, Browne RH. Pulmonary function following early thoracic fusion in non-neuromuscular scoliosis. J Bone Joint Surg Am. 2008 Jun;90(6):1272-81. doi: 10.2106/JBJS.G.00184.
Samdani AF, Ames RJ, Kimball JS, Pahys JM, Grewal H, Pelletier GJ, Betz RR. Anterior vertebral body tethering for immature adolescent idiopathic scoliosis: one-year results on the first 32 patients. Eur Spine J. 2015 Jul;24(7):1533-9. doi: 10.1007/s00586-014-3706-z. Epub 2014 Dec 16.
Crawford CH 3rd, Lenke LG. Growth modulation by means of anterior tethering resulting in progressive correction of juvenile idiopathic scoliosis: a case report. J Bone Joint Surg Am. 2010 Jan;92(1):202-9. doi: 10.2106/JBJS.H.01728. No abstract available.
Samdani AF, Ames RJ, Kimball JS, Pahys JM, Grewal H, Pelletier GJ, Betz RR. Anterior vertebral body tethering for idiopathic scoliosis: two-year results. Spine (Phila Pa 1976). 2014 Sep 15;39(20):1688-93. doi: 10.1097/BRS.0000000000000472.
Miyanji F, Pawelek J, Nasto LA, Rushton P, Simmonds A, Parent S. Safety and efficacy of anterior vertebral body tethering in the treatment of idiopathic scoliosis. Bone Joint J. 2020 Dec;102-B(12):1703-1708. doi: 10.1302/0301-620X.102B12.BJJ-2020-0426.R1.
Spurway AJ, Hurry JK, Gauthier L, Orlik B, Chukwunyerenwa CK, Kishta WE, El-Hawary R. Three-dimensional True Spine Length: A Novel Technique for Assessing the Outcomes of Scoliosis Surgery. J Pediatr Orthop. 2017 Dec;37(8):e631-e637. doi: 10.1097/BPO.0000000000001031.
Sarwahi V, Wendolowski S, Gecelter R, Maguire K, Gambassi M, Orlando D, Lo Y, Amaral T. When Do Patients Return to Physical Activities and Athletics After Scoliosis Surgery?: A Validated Patient Questionnaire Based Study. Spine (Phila Pa 1976). 2018 Feb 1;43(3):167-171. doi: 10.1097/BRS.0000000000002284.
Other Identifiers
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PSSG0121
Identifier Type: -
Identifier Source: org_study_id
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