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.

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.

Investigation of surgical adhesives for vocal fold wound closure.

OBJECTIVES: Surgical adhesives are increasingly used for vocal fold microsurgery to assist wound closure and reduce the risks of scar formation. Currently used vocal fold adhesives such as fibrin glue, however, have thus far not been found to promote wound closure or reduce scarring. The objectives of this study were to investigate the mechanical strength and the cytotoxicity of three commercially available adhesives (Glubran 2, GEM, Viareggio, Italy; BioGlue, CryoLife, Kennesaw, GA; and Tisseel, Baxter Healthcare, Deerfield, IL) for vocal fold wound closure. METHODS: Shear and tension tests were performed on 150 porcine larynges. The cytotoxicity of the adhesives to immortalized human vocal fold fibroblasts was investigated using neutral red uptake assays. RESULTS: The average shear adhesive strength for Tisseel, BioGlue, and Glubran 2 was 13.86 ± 5.03 kilopascal (kPa), 40.92 ± 17.94 kPa, and 68.79 ± 13.29 kPa, respectively. The tensile adhesive strength for Tisseel, BioGlue, and Glubran 2 was 10.70 ± 6.42 kPa, 34.27 ± 12.59 kPa, and 46.67 ± 12.13 kPa, respectively. The vocal fold cell viabilities in extracts of Tisseel, BioGlue, and Glubran 2 were 99.27%, 43.05%, and 1.79%, respectively. CONCLUSION: There was a clear tradeoff between adhesive strength and toxicity. The maximum failure strength in shear or tension of the three surgical adhesives ranked from strongest to the weakest was: 1) Glubran 2, 2) BioGlue, and 3) Tisseel. Tisseel was found to be the least toxic of the three adhesives, whereas Glubran 2 was the most toxic. LEVEL OF EVIDENCE: NA Laryngoscope, 129:2139-2146, 2019.