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

NCT04914507 | Recruiting FDA Device

• 1 other identifier: PSSG0121
• Study Type: interventional
• Target: 106
• Locations: 2 countries
• Sites: 12

Brief 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. 1.The effect on three-dimensional spine growth as compared to normal controls
2. 2.Maintenance of major Cobb angle less than or equal to 50 degrees at skeletal maturity
3. 3.Complications associated with both the procedure and the device

Conditions

Scoliosis Idiopathic

Keywords

anterior vertebral body tethering

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Device: Anterior Vertebral Body Tethering

Interventions

Anterior Vertebral Body Tethering DEVICE

Subject will receive anterior vertebral body tethering surgery.

Anterior Vertebral Body Tethering

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pediatric Spine Foundation: lead

Study Sites (12)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Shriners Children's Chicago

Chicago, Illinois, 60707, United States

RECRUITING

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

Morgan Stanley Childrens Hospital of New York-Presbyterian

New York, New York, 10032, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Shriners Children's Portland

Portland, Oregon, 97239, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

The Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37235, United States

RECRUITING

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8LI, Canada

RECRUITING

Related 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.

  PMID: 29212713 BACKGROUND

• 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.

  PMID: 21191550 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.

  PMID: 18519321 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.

  PMID: 25510515 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.

  PMID: 20048114 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.

  PMID: 24921854 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.

  PMID: 33249889 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.

  PMID: 28614286 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.

  PMID: 28604495 BACKGROUND

Study Officials

• Ron El-Hawary, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler Farber

CONTACT

3197501029; tfarber@pediatricspine.org

Tricia St. Hilaire

CONTACT

4844106413; tsthilaire@pediatricspine.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: September 9, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); CA (1)