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-猫眼课题宝

DOI：

10.1097/brs.0000000000003705

发表时间：

2021-01-01

期刊：

SPINE

影响因子：

通讯作者：

中科院分区：

医学2区

文献类型：

作者：

Guy, Aymeric;Labelle, Hubert;Aubin, Carl-Eric

研究设计.单中心前瞻性随机对照试验。Objective.本研究的目的是评估计算机辅助设计/制造（CAD/CAM）支具设计方法（添加和不添加有限元建模（FEM）模拟）2年后的临床结局、3D矫正、顺应性和生活质量（QoL）。背景数据摘要以往的研究表明，使用CAD/CAM和FEM相结合的支具设计诱导有希望的支具内矫正，更轻，更薄，覆盖更少的躯干表面。然而，其对治疗质量的长期影响尚未得到评估。方法.根据脊柱侧凸研究协会标准化的支具治疗标准，招募了120名青少年特发性脊柱侧凸患者;第一个亚组（CAD）中的61名患者接受了使用CAD/CAM设计的支具;第二个亚组（CAD-FEM）中的59名患者接受了额外模拟和改进的支具，这些支具使用了根据脊柱、肋骨架和骨盆的3D重建构建的患者特定FEM。在初次访视和2年后比较主要胸椎（MT）和胸腰椎/腰椎（TL/L）Cobb角、矢状曲线和心尖旋转。分别使用嵌入式温度传感器和SRS-22 r问卷跟踪患者依从性和生活质量。结果44名患者使用CAD-FEM支具，50名患者使用CAD支具完成了研究。平均支架内矫正为9度MT（8度CAD-FEM，10度CAD，P = 0.054）和12度TL/L（两个亚组相同，P = 0.91）。从初始畸形开始的无支架2年进展为

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 degrees MT (8 degrees CAD-FEM, 10 degrees CAD, P = 0.054) and 12 degrees TL/L (same for both subgroups, P = 0.91). Out-of-brace 2-year progression from initial deformity was

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

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