{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T14:50:14Z","timestamp":1787755814150,"version":"build-2784847793"},"reference-count":16,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","license":[{"start":{"date-parts":[[2025,7,1]],"date-time":"2025-07-01T00:00:00Z","timestamp":1751328000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Vertebral body tethering (VBT) offers an alternative treatment for patients with idiopathic scoliosis. We present our finalized Food and Drug Administration Investigational Device Exemption (IDE) study results on VBT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>We retrospectively reviewed patients with Lenke Type IA\/B curves who underwent VBT between 2011 and 2015. Clinical, radiographic, perioperative, and complications data were prospectively collected.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Fifty-seven patients (mean age 12.4 \u00b1 1.3 years) were enrolled and followed for 6.6 \u00b1 1.6 years (range: 3.0-10.2 years). Thoracic Cobb angle measured 40.4 \u00b1 6.8\u00b0 preoperatively with correction to 14.5 \u00b1 9.0\u00b0 at 2 years and slight regression to 22.1 \u00b1 12.4\u00b0 at last follow-up. Median Sanders and Risser were 3 and 0, respectively. At last follow-up, 71% of patients (39\/56) had curves \u226430\u00b0 and 98% (55\/56) had achieved skeletal maturity. There were no major neurologic or pulmonary complications. However, 10 patients required 13 revisions; 2 required conversion to fusion. Percent predicted forced expiratory volume and forced vital capacity dropped from 85% and 87%, respectively, to 80% and 82% at the final follow-up.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>These finalized IDE results highlight VBT as a safe, effective treatment for skeletally immature patients with idiopathic scoliosis. However, complication and revision rates remain concerning, and patients should be counseled appropriately.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of Evidence:<\/jats:title>\n                    <jats:p>\n                      <jats:underline>Level III<\/jats:underline>\n                      . See Instructions for Authors for a complete description of levels of evidence.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.2106\/jbjs.oa.25.00171","type":"journal-article","created":{"date-parts":[[2025,9,11]],"date-time":"2025-09-11T18:01:52Z","timestamp":1757613712000},"update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":1,"title":["Results of a Retrospective FDA Investigational Device Exemption Study for Anterior Vertebral Body Tethering in Adolescent Idiopathic Scoliosis with 3-Year to 10-Year Follow-Up"],"prefix":"10.2106","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9059-1750","authenticated-orcid":false,"given":"Taemin","family":"Oh","sequence":"first","affiliation":[{"name":"Shriners Children's Philadelphia, Philadelphia, 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