Main Article Content
Study Design: Literature Review
Background: This white paper reviews the early reported outcomes of anterior vertebral body tethering (AVBT) and provides a brief update on the recent changes in regulatory status.
Growth modulation by AVBT has the potential to transform scoliosis treatment in children and adolescents by reducing spinal curvature without definitive fusion. To date, nearly all patients with anterior vertebral body tethering (AVBT) have been treated in off-label use, sometimes with controversial indications.
Methods: A literature review was conducted of published papers and abstracts from national conferences. We searched PubMed for “vertebral body stapling” and “vertebral body tethering,” including only primary research. We also reviewed the last 10 programs of ICEOS, SRS, and POSNA. Regulatory officials within the spinal device industry and the FDA were also consulted.
Results: Early published experience (5 papers) in 67 patients and unpublished data (8 presentations) in over 200 patients suggests that AVBT can effectively prevent curve progression in the majority of skeletally immature patients. Rates of complications and secondary surgery for curve progression or overcorrection are variable and necessitate further investigation.
Conclusions: With the recent FDA regulatory approval of the vertebral tether under and Humanitarian Device Exemption (HDE) mechanism, we are poised to better understand the long term outcomes of this novel and potentially disruptive approach to the treatment of pediatric spine deformity.