Braces Designed Using CAD/CAM Combined or Not With Finite Element Modeling Lead to Effective Treatment and Quality of Life After 2 Years: A Randomized Controlled Trial

STUDY DESIGN.Single-center prospective randomized controlled trial. OBJECTIVE.The aim of this study was to assess the computer-aided design/manufacturing (CAD/CAM) brace design approach, with and without added finite element modeling (FEM) simulations, after 2 years in terms of clinical outcomes, 3D...

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Bibliographic Details
Published in:Spine (Philadelphia, Pa. 1976) Pa. 1976), 2021-01, Vol.46 (1), p.9-16
Main Authors: Guy, Aymeric, Labelle, Hubert, Barchi, Soraya, Audet-Duchesne, Elisabeth, Cobetto, Nikita, Parent, Stefan, Raison, Maxime, Aubin, Carl-Éric
Format: Article
Language:English
Subjects:
Adolescent
Braces
Child
Computer-Aided Design
Female
Finite Element Analysis
Humans
Male
Pelvis
Prospective Studies
Quality of Life
Rib Cage
Scoliosis - therapy
Spine
Treatment Outcome
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Summary:STUDY DESIGN.Single-center prospective randomized controlled trial. OBJECTIVE.The aim of this study was to assess the computer-aided design/manufacturing (CAD/CAM) brace design approach, with and without added finite element modeling (FEM) simulations, after 2 years in terms of clinical outcomes, 3D correction, compliance, and quality of life (QoL). SUMMARY OF BACKGROUND DATA..Previous studies demonstrated that braces designed using a combination of CAD/CAM and FEM induced promising in-brace corrections, were lighter, thinner, and covered less trunk surface. Yet, their long-term impact on treatment quality has not been evaluated. METHODS.One-hundred twenty adolescent idiopathic scoliosis patients were recruited following Scoliosis Research Society standardized criteria for brace treatment; 61 patients in the first subgroup (CAD) were given braces designed using CAD/CAM; 59 in the second subgroup (CAD-FEM) received braces additionally simulated and refined using a patient-specific FEM built from 3D reconstructions of the spine, rib cage and pelvis. Main thoracic (MT) and thoraco-lumbar/lumbar (TL/L) Cobb angles, sagittal curves, and apical rotations were compared at the initial visit and after 2 years. Patient compliance and QoL were tracked respectively by using embedded temperature sensors and SRS-22r questionnaires. RESULTS.Forty-four patients with CAD-FEM braces and 50 with CAD braces completed the study. Average in-brace correction was 9° MT (8° CAD-FEM, 10° CAD, P = 0.054) and 12° TL/L (same for both subgroups, P = 0.91). Out-of-brace 2-year progression from initial deformity was
ISSN:0362-2436
1528-1159
DOI:10.1097/BRS.0000000000003705