Optimized braces for the treatment of adolescent idiopathic scoliosis: A study protocol of a prospective randomised controlled trial.

INTRODUCTION: Adolescent Idiopathic Scoliosis (AIS) is a 3D deformity of the spine that affects 3% of the adolescent population. Conservative treatments like bracing aim to halt the progression of the curve to the surgical threshold. Computer-aided design and manufacturing (CAD/CAM) methods for brace design and manufacturing are becoming increasingly used. Linked to CAD/CAM and 3D radiographic reconstruction techniques, we developed a finite element model (FEM) enabling to simulate the brace effectiveness before its fabrication, as well as a semi-automatic design processes. The objective of this randomized controlled trial is to compare and validate such FEM semi-automatic algorithm used to design nighttime Providence-type braces. METHODS AND ANALYSIS: Fifty-eight patients with AIS aged between 10 to 16-years and skeletally immature will be recruited. At the delivery stage, all patients will receive both a Providence-type brace optimized by the semi-automatic algorithm leveraging a patient-specific FEM (Test) and a conventional Providence-type brace (Control), both designed using CAD/CAM methods. Biplanar radiographs will be taken for each patient with both braces in a randomized crossover approach to evaluate immediate correction. Patients will then be randomized to keep either the Test or Control brace as prescribed with a renewal if necessary, and will be followed over two years. The primary outcome will be the change in Cobb angle of the main curve after two years. Secondary outcomes will be brace failure rate, quality of life (QoL) and immediate in-brace correction. This is a single-centre study, double-blinded (participant and outcome assessor) randomized controlled trial (RCT). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT05001568.

Automated design of nighttime braces for adolescent idiopathic scoliosis with global shape optimization using a patient-specific finite element model.

Adolescent idiopathic scoliosis is a complex three-dimensional deformity of the spine, the moderate forms of which require treatment with an orthopedic brace. Existing brace design approaches rely mainly on empirical manual processes, vary considerably depending on the training and expertise of the orthotist, and do not always guarantee biomechanical effectiveness. To address these issues, we propose a new automated design method for creating bespoke nighttime braces requiring virtually no user input in the process. From standard biplanar radiographs and a surface topography torso scan, a personalized finite element model of the patient is created to simulate bracing and the resulting spine growth over the treatment period. Then, the topography of an automatically generated brace is modified and simulated over hundreds of iterations by a clinically driven optimization algorithm aiming to improve brace immediate and long-term effectiveness while respecting safety thresholds. This method was clinically tested on 17 patients prospectively recruited. The optimized braces showed a highly effective immediate correction of the thoracic and lumbar curves (70% and 90% respectively), with no modifications needed to fit the braces onto the patients. In addition, the simulated lumbar lordosis and thoracic apical rotation were improved by 5° ± 3° and 2° ± 3° respectively. Our approach distinguishes from traditional brace design as it relies solely on biomechanically validated models of the patient's digital twin and a design strategy that is entirely abstracted from empirical knowledge. It provides clinicians with an efficient way to create effective braces without relying on lengthy manual processes and variable orthotist expertise to ensure a proper correction of scoliosis.

Finite element simulation of growth modulation during brace treatment of adolescent idiopathic scoliosis.

Adolescent idiopathic scoliosis (AIS) is a spine deformity whose progression during growth is affected by asymmetrical loads acting on the spine. The conservative brace treatment aims to limit the deformity's progression until the end of skeletal growth. This study's objective was to develop a patient-specific finite element model (FEM) simulating immediate in-brace (IB) correction and subsequent growth modulation over 2 years of treatment. Thirty-five retrospective AIS cases with documented correction over 2 years were analyzed. For each case, a patient-specific FEM was built and IB correction was simulated. Vertebral growth and its modulation were modeled using simulated pressures on epiphyseal vertebral growth plates, including a compliance factor representing the recorded brace wear. The simulated Cobb angles, thoracic kyphosis, lumbar lordosis, and apical vertebral rotation were compared with the actual measurements immediately IB and out-of-brace (OOB) at the 2-year follow-up. Treatment outcomes according to simulated compliance scenarios of no brace-wear versus full brace-wear were also computed. The average immediate IB difference between the simulated and actual Cobb angle was 4.9° (main thoracic [MT]) and 3.7° (thoraco-lumbar/lumbar [TL/L]). Two-year OOB, it was 5.6° (MT) and 5.4° (TL/L). The no brace-wear and full brace-wear compliance scenarios resulted respectively in 15/35 (43%) and 31/35 (89%) simulated spine deformities progressing by <5° over 2 years of treatment. Clinical significance: the FEM's ability to simulate the final correction with an accuracy on the order of the radiological measurements' interoperator reproducibility, combined with its sensitivity to brace-wear compliance, provides confidence in the model's predictions for a comparative context of use like improving a brace's design before its application.

A cadaveric perfused model with antegrade arteriovenous pulsatile circulation: a new tool for teaching endovascular skills.

BACKGROUND: The benefits of using cadaveric humans in surgical training are well documented, and knowledge of the latest endovascular techniques is essential in the daily practice of vascular surgeons. Our study explores the feasibility of an affordable human cadaveric model with pulsatile and heated antegrade perfusion for reliable and reproducible endovascular or surgical simulation. METHODS: We undertook cannulation of 7 human cadavers embalmed in a saturated salt solution to create a left-to-right central perfusion with a heated solution, from the ascending thoracic aorta to the right atrium. To that end, we used surgically created carotidojugular and femorofemoral arteriovenous fistulas. Biomedical engineers designed a prototype pump for pulsatile circulation. We monitored invasive blood pressure and temperature. We used this model for training for endovascular thoracic aortic procedures and open vascular surgeries. RESULTS: The prototype pump achieved a pulsatile flow rate of 4.7 L/min. Effective cadaveric perfusion was achieved for several hours, not only with an arterioarterial pathway but also with arteriovenous circulation. The arterial pressures and in situ temperatures accurately restored vascular functions for life-like conditions. This new model made it possible to successfully perform thoracic endovascular aortic repair, subclavian artery stenting and simulation of abdominal open vascular trauma management. The saturated salt solution method and a specifically designed pump improved cost competitiveness. CONCLUSION: Endovascular simulation on human cadavers, optimized with the pulsatile and heated perfusion system, can be a dynamic adjunct for surgical training and familiarization with new devices. This reproducible teaching tool could be relevant in all surgery programs.

Biomechanical Effects of Thoracolumbosacral Orthosis Design Features on 3D Correction in Adolescent Idiopathic Scoliosis: A Comprehensive Multicenter Study.

STUDY DESIGN: Multicenter numerical study. OBJECTIVE: To biomechanically analyze and compare various passive correction features of braces, designed by several centers with diverse practices, for three-dimensional (3D) correction of adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: A wide variety of brace designs exist, but their biomechanical effectiveness is not clearly understood. Many studies have reported brace treatment correction potential with various degrees of control, making the objective comparison of correction mechanisms difficult. A Finite Element Model simulating the immediate in-brace corrective effects has been developed and allows to comprehensively assess the biomechanics of different brace designs. METHODS: Expert clinical teams (one orthotist and one orthopedist) from six centers in five countries participated in the study. For six scoliosis cases with different curve types respecting SRS criteria, the teams designed two braces according to their treatment protocol. Finite Element Model simulations were performed to compute immediate in-brace 3D correction and skin-to-brace pressures. All braces were randomized and labeled according to 21 design features derived from Society on Scoliosis Orthopaedic and Rehabilitation Treatment proposed descriptors, including positioning of pressure points, orientation of push vectors, and sagittal design. Simulated in brace 3D corrections were compared for each design feature class using ANOVAs and linear regressions (significance P ≤ 0.05). RESULTS: Seventy-two braces were tested, with significant variety in the design approaches. Pressure points at the apical vertebra level corrected the main thoracic curve better than more caudal locations. Braces with ventral support flattened the lumbar lordosis. Lateral and ventral skin-to-brace pressures were correlated with changes in thoracolumbar/lumbar Cobb and lumbar lordosis (r =- 0.53, r = - 0.54). Upper straps positioned above T10 corrected the main thoracic Cobb better than those placed lower. CONCLUSIONS: The corrective features of various scoliosis braces were objectively compared in a systematic approach with minimal biases and variability in test parameters, providing a better biomechanical understanding of individual passive mechanisms' contribution to 3D correction.

3D Radiological Outcomes and Quality of Life of Patients With Moderate Idiopathic Scoliosis Treated With Anterior Vertebral Growth Modulation Versus Bracing: Two-Year Follow-up.

STUDY DESIGN: Observational cohort study. OBJECTIVE: To test the hypothesis that anterior vertebral body growth modulation (AVBGM) achieves 3D deformity correction after 2-year follow-up while brace treatment limits curve progression for moderate idiopathic scoliosis (30-50°). SUMMARY OF BACKGROUND DATA: For idiopathic scoliosis, bracing and AVBGM have overlapping indications in skeletally immature patients with moderate scoliosis curve angles, creating a grey zone in clinical practice between them. The relative 3D deformity control performance over a 2-year period between these fusionless treatments is still uncertain. METHODS: A retrospective review of a prospective idiopathic scoliosis patients database, recruited between 2013 and 2018 was performed. Inclusion criteria were skeletally immature patients (Risser 0-2), with Cobb angles between 30° and 50° and a 2-year follow-up after bracing or AVBGM. 3D radiological parameters and health related quality of life (HRQoL) scores were evaluated. Unpaired t test was used. RESULTS: Thirty nine patients (12.7 ± 1.3 y.o.) with Cobb angles more than or equal to 30° treated with brace and 41 patients (11.8 ± 1.2 y.o.) with presenting Cobb angles less than or equal to 50° who received AVBGM were reviewed. The statistical analysis of 3D deformity measurements showed that at 2-year follow-up, only the 3D spine length and both sides apical vertebral heights changed significantly with brace treatment. While AVBGM treatment achieved statistically significant correction differences in thoracic and lumbar Cobb angles, TrueKyphosis, 3D spine length, and selective left apical vertebral height ( P < 0.05). 35% of brace patients had a curve progression of more than 5° at final follow-up while it was 0% for AVBGM. HRQoL assessment showed no statistically significant differences between pre and post SRS-22 total scores for each group ( P > 0.05). CONCLUSION: Even though these two cohorts are not fully comparable, bracing seems to control progression for a significant portion of patients with moderate scoliosis curves, while AVBGM significantly corrected and maintained 3D deformity parameters at 2-year follow-up.

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 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 <4° for all 3D measurements. Sixty-six percent of all cases (30 CAD-FEM, 35 CAD) met the ≤5° curve progression criterion, 83% (38 CAD-FEM, 43 CAD) stayed <45°, and 6% (5 CAD-FEM, 1 CAD) underwent fusion surgery. 3D correction, compliance, and QoL were not significantly different between both subgroups (P > 0.05). CONCLUSION: After 2 years, patients with braces designed using CAD/CAM with/without FEM had satisfying clinical outcomes (compared to the BrAIST study), 3D corrections, compliance and QoL. A more comprehensive optimization of brace treatment remains to be accomplished. LEVEL OF EVIDENCE: 2.