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Anterior vertebral body tethering (AVBT) is a novel, minimally invasive, growth modulation technique that was recently approved by the FDA under a Humanitarian Device Exemption (HDE). The goal of AVBT is to control curve progression by applying compression on the convex side of the spine deformity. While there has been great initial enthusiasm about the technique as an alternate treatment option to spinal fusion for skeletally immature children with scoliosis, there is a need to better understand the long-term outcomes.
The purpose of this study is to report the long-term clinical outcomes of skeletally immature patients treated with AVBT, specifically:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterior Vertebral Body Tethering | Other | The subject is will receive anterior vertebral body tethering surgery, as clinically indicated, after all pre-operative assessments are complete. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anterior Vertebral Body Tethering | Device | Subject will receive anterior vertebral body tethering surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effect on three-dimensional spine growth as compared to normal controls | The three-dimensional spine growth of the subjects will be measured at each study timepoint and compared to known normal controls. | 5 years |
| Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity | Subjects who maintain a major Cobb angle less than or equal to 50 degrees at skeletal maturity will be considered a "success." | 5 years |
| Complications associated with both the procedure and the device | Subjects will be monitored for complications associated with both the procedure and the device. | 5 years |
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Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tyler Farber | Contact | 3197501029 | tfarber@pediatricspine.org | |
| Tricia St. Hilaire | Contact | 4844106413 | tsthilaire@pediatricspine.org |
| Name | Affiliation | Role |
|---|---|---|
| Ron El-Hawary, MD | Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Hospital | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29212713 | Background | 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. | |
| 21191550 |
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| Shriners Children's Chicago | Recruiting | Chicago | Illinois | 60707 | United States |
| Gillette Children's Specialty Healthcare | Recruiting | Saint Paul | Minnesota | 55101 | United States |
|
| Washington University | Recruiting | St Louis | Missouri | 63130 | United States |
| Morgan Stanley Childrens Hospital of New York-Presbyterian | Recruiting | New York | New York | 10032 | United States |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Shriners Children's Portland | Recruiting | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| The Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University | Recruiting | Nashville | Tennessee | 37235 | United States |
| Primary Children's Hospital | Recruiting | Salt Lake City | Utah | 84113 | United States |
| Children's Hospital of Eastern Ontario | Recruiting | Ottawa | Ontario | K1H 8LI | Canada |
|
| 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. |
| 18519321 | Background | 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. |
| 25510515 | Background | 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. |
| 20048114 | Background | 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. |
| 24921854 | Background | 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. |
| 33249889 | Background | 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. |
| 28614286 | Background | 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. |
| 28604495 | Background | 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. |