ArticleJB & JS open access
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.
Article in JB & JS open access. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: 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. Methods: 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. Results: Fifty-seven patients (mean age 12.4 ± 1.3 years) were enrolled and followed for 6.6 ± 1.6 years (range: 3.0-10.2 years). Thoracic Cobb angle measured 40.4 ± 6.8° preoperatively with correction to 14.5 ± 9.0° at 2 years and slight regression to 22.1 ± 12.4° at last follow-up. Median Sanders and Risser were 3 and 0, respectively. At last follow-up, 71% of patients (39/56) had curves ≤30° 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. Conclusion: 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. Level of Evidence: Level III. See Instructions for Authors for a complete description of levels of evidence.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.