Immediate Correction of Idiopathic Scoliosis With Nighttime Braces Created by a Fully Automated Generative Design Algorithm: A Randomized Controlled Crossover Trial

Single-center, double-blinded, prospective crossover randomized controlled trial. 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-bra...

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Veröffentlicht in:Spine (Philadelphia, Pa. 1976) Jg. 49; H. 23; S. 1615
Hauptverfasser: Coulombe, Maxence, Guy, Aymeric, Joncas, Julie, Manitiu, Anton, Poirier, Philippe, Barchi, Soraya, Chémaly, Olivier, Brassard, Félix, Parent, Stefan, Labelle, Hubert, Aubin, Carl-Éric
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States 01.12.2024
Schlagworte:
Adolescent
Algorithms
Braces
Child
Cross-Over Studies
Double-Blind Method
Equipment Design
Female
Humans
Male
Prospective Studies
Scoliosis - diagnostic imaging
Scoliosis - therapy
Treatment Outcome
ISSN:1528-1159, 1528-1159
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Zusammenfassung:Single-center, double-blinded, prospective crossover randomized controlled trial. 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. 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. 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. 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. 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 2.
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ISSN:1528-1159
1528-1159
DOI:10.1097/BRS.0000000000005138