Immediate Correction of Idiopathic Scoliosis With Nighttime Braces Created by a Fully Automated Generative Design Algorithm: A Randomized Controlled Crossover Trial.
Maxence Coulombe, Aymeric Guy, Julie Joncas, Anton Manitiu, Philippe Poirier, Soraya Barchi, Olivier Chémaly, Félix Brassard, Stefan Parent, Hubert Labelle, Carl-Éric Aubin
{"title":"Immediate Correction of Idiopathic Scoliosis With Nighttime Braces Created by a Fully Automated Generative Design Algorithm: A Randomized Controlled Crossover Trial.","authors":"Maxence Coulombe, Aymeric Guy, Julie Joncas, Anton Manitiu, Philippe Poirier, Soraya Barchi, Olivier Chémaly, Félix Brassard, Stefan Parent, Hubert Labelle, Carl-Éric Aubin","doi":"10.1097/BRS.0000000000005138","DOIUrl":null,"url":null,"abstract":"<p><strong>Study design: </strong>Single-center, double-blinded, prospective crossover randomized controlled trial.</p><p><strong>Objective: </strong>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.</p><p><strong>Summary of background data: </strong>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.</p><p><strong>Methods: </strong>Fifty-eight skeletally immature patients diagnosed with IS, aged between 10 and 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.</p><p><strong>Results: </strong>The targeted 55 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, whereas it was 89% 25 (test) versus 87% 28 (control) for the thoracolumbar/lumbar (TLL) spine. The immediate correction with the test brace was noninferior 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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Level of evidence: </strong>Level 2.</p>","PeriodicalId":22193,"journal":{"name":"Spine","volume":" ","pages":"1615-1620"},"PeriodicalIF":2.6000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Spine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/BRS.0000000000005138","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/22 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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 and 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 55 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, whereas it was 89% 25 (test) versus 87% 28 (control) for the thoracolumbar/lumbar (TLL) spine. The immediate correction with the test brace was noninferior 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.
期刊介绍：
Lippincott Williams & Wilkins is a leading international publisher of professional health information for physicians, nurses, specialized clinicians and students. For a complete listing of titles currently published by Lippincott Williams & Wilkins and detailed information about print, online, and other offerings, please visit the LWW Online Store.
Recognized internationally as the leading journal in its field, Spine is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of Spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. The Journal does not publish articles reporting material that has been reported at length elsewhere.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
