Immediate Correction of Idiopathic Scoliosis with Nighttime Braces Created by A fully-automated Generative Design Algorithm: A Randomized Controlled Crossover Trial.

Autor:	Coulombe M; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Guy A; Sainte-Justine University Hospital Center, Montreal, QC, Canada.; Polytechnique Montreal, Montreal, QC, Canada., Joncas J; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Manitiu A; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Poirier P; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Barchi S; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Chémaly O; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Brassard F; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Parent S; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Labelle H; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada., Aubin CÉ; Université de Montréal, Montreal, QC, Canada.; Sainte-Justine University Hospital Center, Montreal, QC, Canada.; Polytechnique Montreal, Montreal, QC, Canada.
Jazyk:	angličtina
Zdroj:	Spine [Spine (Phila Pa 1976)] 2024 Oct 22. Date of Electronic Publication: 2024 Oct 22.
DOI:	10.1097/BRS.0000000000005138
Abstrakt:	Study Design: Single center, double blinded, prospective crossover randomized controlled trial. Objective: To clinically validate the efficacy of nighttime braces designed automatically by a generative design algorithm to treat idiopathic scoliosis (IS). The tested hypothesis was the clinical equivalence of immediate in-brace correction for the new automatically generated brace design versus a standard Providence-type brace. Summary of Background Data: Documented efficacy of brace treatment varies between centers, and depends on the empirical expertise of the treating orthotist. Our group previously developed a fully-automated generative brace design algorithm that leverages a patient-specific finite element model (FEM) to optimize brace geometry and correction before its fabrication. Methods: Fifty-eight skeletally immature patients diagnosed with IS, aged between 10 to 16 years were recruited. All patients received both a nighttime brace automatically generated by the algorithm (Test) and a Providence-type brace designed by an expert orthotist (Control). Radiographs were taken for each patient with both braces in a randomized crossover approach to evaluate immediate in-brace correction. Results: The targeted fifty-five patients (48 females, 7 males) completed the study. The immediate Cobb angle correction was 57% ± 19 (Test) versus 58% ± 21 (Control) for the main thoracic (MT) curve, while it was 89% ± 25 (Test) versus 87% ± 28 (Control) for the thoraco-lumbar/lumbar (TLL) spine. The immediate correction with the Test brace was non-inferior to that of the Control brace (P < 0.001). The order in which the braces were tested did not have a residual effect on the immediate correction. Conclusion: The fully-automated generative brace design algorithm proves to be clinically relevant, allowing for immediate in-brace correction equivalent to that of braces designed by expert orthotists. Patient 2 years follow-up will continue. This method's integration could help design and rationalize the design of braces for the treatment of IS. Level of Evidence: Level 2. Competing Interests: Conflicts of Interest and Source of Funding: Author HL: Canadian Institute of Health Research [H. Labelle et al,2017-2024, #375116]. URL: https://cihr-irsc.gc.ca/e/193.html and Cofounder of the company Spinologics Inc, Author CEA: Canada First Research Excellence Fund [CE Aubin et al,2016-2026, #CFREF-201 5-00008], a discovery grant from the Natural Sciences and Engineering Research Council of Canada (NSERC), and a NSERC Alliance university-industry grant with Medtronic of Canada paid to the university (outside the scope of the current study). The NSERC grant with Medtronic has not been used to fund this research project. A patent application on the optimization algorithm has been submitted. Author MC: TransMedTech Institute [Scholarship for Graduate Studies, no grant number associated].URL: https://transmedtech.org/en/ The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
Databáze:	MEDLINE
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