Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Sep 1;103(17):1611-1619.
doi: 10.2106/JBJS.20.01503.

Prospective Follow-up Report on Anterior Vertebral Body Tethering for Idiopathic Scoliosis: Interim Results from an FDA IDE Study

Amer F Samdani  1 , Joshua M Pahys  1 , Robert J Ames  2 , Harsh Grewal  3 , Glenn J Pelletier  4 , Steven W Hwang  1 , Randal R Betz  5
Affiliations

Prospective Follow-up Report on Anterior Vertebral Body Tethering for Idiopathic Scoliosis: Interim Results from an FDA IDE Study

Amer F Samdani et al. J Bone Joint Surg Am. .

Abstract

Background: Anterior vertebral body tethering (aVBT) has emerged as a novel treatment option for patients with idiopathic scoliosis. We present the results from the first U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study on aVBT.

Methods: In this prospective review of a retrospective data set, eligible patients underwent aVBT at a single center from August 2011 to July 2015. Inclusion criteria included skeletally immature patients with Lenke type-1A or 1B curves between 30° and 65°. Clinical and radiographic parameters were collected, with the latter measured by an independent reviewer.

Results: Fifty-seven patients (49 girls and 8 boys), with a mean age (and standard deviation) of 12.4 ± 1.3 years (range, 10.1 to 15.0 years), were enrolled in the study. The patients had a mean of 7.5 ± 0.6 levels tethered, the mean operative time was 223 ± 79 minutes, and the mean estimated blood loss was 106 ± 86 mL. The patients were followed for an average of 55.2 ± 12.5 months and had a mean Risser grade of 4.2 ± 0.9 at the time of the latest follow-up. The main thoracic Cobb angle was a mean of 40.4° ± 6.8° preoperatively and was corrected to 18.7° ± 13.4° at the most recent follow-up. In the sagittal plane, T5-T12 kyphosis measured 15.5° ± 10.0° preoperatively, 17.0° ± 10.1° postoperatively, and 19.6° ± 12.7° at the most recent follow-up. Eighty percent of patients had curves of <30° at the most recent follow-up. The most recent Scoliosis Research Society (SRS) scores averaged 4.5 ± 0.4, and scores on the self-image questionnaire averaged 4.4 ± 0.7. No major neurologic or pulmonary complications occurred. Seven (12.3%) of 57 patients had a revision: 5 were done for overcorrection and 2, for adding-on.

Conclusions: Anterior VBT is a promising technique that has emerged as a treatment option for patients with immature idiopathic scoliosis. We present the results from the first FDA-approved IDE study on aVBT, which formed the basis for the eventual Humanitarian Device Exemption approval. The findings affirm the safety and efficacy of this technique and suggest opportunities for improvement, particularly with respect to reoperation rates.

Level of evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

PubMed Disclaimer

Conflict of interest statement

Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/G589).

References

    1. Nachemson AL, Peterson LE. Effectiveness of treatment with a brace in girls who have adolescent idiopathic scoliosis. A prospective, controlled study based on data from the Brace Study of the Scoliosis Research Society. J Bone Joint Surg Am. 1995 Jun;77(6):815-22.
    1. Weinstein SL, Dolan LA, Wright JG, Dobbs MB. Effects of bracing in adolescents with idiopathic scoliosis. N Engl J Med. 2013 Oct 17;369(16):1512-21. Epub 2013 Sep 19.
    1. Merenda L, Costello K, Santangelo AM, Mulcahey MJ. Perceptions of self-image and physical appearance: conversations with typically developing youth and youth with idiopathic scoliosis. Orthop Nurs. 2011 Nov-Dec;30(6):383-90.
    1. D’Amato CR, Griggs S, McCoy B. Nighttime bracing with the Providence brace in adolescent girls with idiopathic scoliosis. Spine (Phila Pa 1976). 2001 Sep 15;26(18):2006-12.
    1. Cheung ZB, Selverian S, Cho BH, Ball CJ, Kang-Wook Cho S. Idiopathic scoliosis in children and adolescents: emerging techniques in surgical treatment. World Neurosurg. 2019 Oct;130:e737-42. Epub 2019 Jul 5.

MeSH terms