A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Scoliosis Idiopathic Clinical Trial

Official title:

A Prospective Analysis of Long-Term Clinical Outcomes and 3D Spine Growth in Anterior Vertebral Body Tethering

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914507
• Other study ID #: PSSG0121
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: September 2029

Study information

• Verified date: November 2023
• Source: Pediatric Spine Foundation
• Contact: Tyler Farber
• Phone: 3197501029
• Email: tfarber[@]pediatricspine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: September 2029
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria: Skeletally immature patients that receive AVBT surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis. Specifically:

• Diagnosis of idiopathic scoliosis

• 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:

• Presence of any systemic infection, local infection, or skin compromise at the anticipated surgical site

• 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

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis Idiopathic

Intervention

Device:
• Anterior Vertebral Body Tethering
Subject will receive anterior vertebral body tethering surgery.

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
United States	The Medical University of South Carolina	Charleston	South Carolina
United States	Shriners Children's Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Vanderbilt University	Nashville	Tennessee
United States	Morgan Stanley Childrens Hospital of New York-Presbyterian	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Shriners Children's Portland	Portland	Oregon
United States	Washington University	Saint Louis	Missouri
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota
United States	Primary Children's Hospital	Salt Lake City	Utah
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pediatric Spine Foundation

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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