Immediate Correction of Idiopathic Scoliosis With Nighttime Braces Created by a Fully Automated Generative Design...

Area of Science:

• Orthopedics
• Biomedical Engineering
• Medical Device Design

Background:

• Brace treatment efficacy for idiopathic scoliosis (IS) varies, influenced by orthotist expertise.
• A generative design algorithm using patient-specific finite-element models (FEM) was developed for automated brace optimization.
• This algorithm aims to standardize and improve brace design for IS treatment.

Purpose of the Study:

• To clinically validate the efficacy of automatically generated nighttime braces for idiopathic scoliosis (IS).
• To test the hypothesis of clinical equivalence in immediate in-brace correction between algorithm-generated and standard Providence-type braces.

Main Methods:

• A single-center, prospective, double-blinded, crossover randomized controlled trial was conducted.
• Fifty-eight skeletally immature patients (10–16 years) with IS were enrolled.
• Patients received both an algorithm-generated (test) and a Providence-type (control) brace for immediate in-brace correction assessment via radiographs.

Main Results:

• 55 patients completed the study.
• Immediate Cobb angle correction was comparable between the test and control braces for both main thoracic (57% vs. 58%) and thoracolumbar/lumbar (89% vs. 87%) curves.
• The algorithm-generated brace demonstrated noninferior immediate correction compared to the standard brace (P < 0.001).

Conclusions:

• The automated generative brace design algorithm is clinically relevant for idiopathic scoliosis (IS) treatment.
• It achieves immediate in-brace correction equivalent to braces designed by expert orthotists.
• Integration of this method can rationalize and standardize the design of braces for IS.