Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 Dec 1;49(23):1615-1620.
doi: 10.1097/BRS.0000000000005138. Epub 2024 Oct 22.

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

Maxence Coulombe  1   2 , Aymeric Guy  2   3 , Julie Joncas  2 , Anton Manitiu  1   2 , Philippe Poirier  1   2 , Soraya Barchi  2 , Olivier Chémaly  1   2 , Félix Brassard  1   2 , Stefan Parent  1   2 , Hubert Labelle  1   2 , Carl-Éric Aubin  1   2   3
Affiliations
Randomized Controlled Trial

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

Maxence Coulombe et al. Spine (Phila Pa 1976). .

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.

Level of evidence: Level 2.

PubMed Disclaimer

References

    1. Richards BS, Bernstein RM, D’Amato CR, Thompson GH. Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management. Spine. 2005;30:2068–2075.
    1. Wiemann JM, Shah SA, Price CT. Nighttime bracing versus observation for early adolescent idiopathic scoliosis. J Pediatr Orthop. 2014;34:603–606.
    1. Negrini S, Aulisa AG, Cerny P, et al. The classification of scoliosis braces developed by SOSORT with SRS, ISPO, and POSNA and approved by ESPRM. Eur Spine J. 2022;31:980–989.
    1. Guy A, Coulombe M, Labelle H, et al. Biomechanical effects of thoracolumbosacral orthosis design features on 3D correction in adolescent idiopathic scoliosis: a comprehensive multicenter study. Spine (Phila Pa 1976). 2022;47:1103–1110.
    1. Negrini S, Minozzi S, Bettany-Saltikov J, et al. Braces for idiopathic scoliosis in adolescents. Cochrane Database Syst Rev. 2010:CD006850.

Publication types