Supplementary Materials: The development of a 3D-printed brace for treatment of adolescent idiopathic scoliosis: a cross-sectional feasibility study protocol

Introduction: A widely used non-operative treatment for adolescent idiopathic scoliosis is
bracing. Yet, traditional handmade rigid thoracolumbar braces pose challenges related to
variability, practicality, and compliance. Innovative 3D-printed braces potentially overcome some of these limitations but clear criteria for the trajectory from brace development to successful clinical implementation are currently lacking. This study will propose mechanical tests and assess the feasibility for subsequent implementation into clinical practice of a novel 3D-printed brace for treatment of adolescent idiopathic scoliosis.

Methods and analysis: This prospective, cross-sectional feasibility study consists of two
parts: (1) (bio-)mechanical evaluation and (2) evaluation in a clinical setting of a 3D-printed
brace in 20 patients with adolescent idiopathic scoliosis. The mechanical evaluation will
assess the structural properties of the 3D-printed scoliosis brace. Clinical evaluation will
determine safety, comfort, limited efficacy of in-brace correction and manufacturing costs for the 3D-printed scoliosis brace as compared to a conventional brace used in standard care.

Ethics and dissemination: Ethical approval is pending review and will be obtained from
the Medical Ethical Testing Committee of MUMC+ before the study commences. Results will be published in a peer-reviewed journal and additionally disseminated through scientific conferences and social media aiming to reach a broad audience including patients.