3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial

Abstract

IntroductionAdolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.Methods and analysisPatients with AIS (age 10–16 years) with Risser sign 0-II, Cobb angle of main curve of 20°−40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen’s design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.Ethics and disseminationThis study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.Trial registration numberChiCTR1900027379, pre-results.

Affective association with and preference for flexible brace colors in older adults with spinal deformities

“…This may indicate that the respondents in this study have a much poorer affective association toward the brace, regardless of the color. This could also be explained by the poor user acceptance and affective association of patients toward medical garments 31,34 and it is possible that context would greatly shape affective associations toward the colors used. As such, the feedback or reaction toward color swatches might not be always applicable to real‐world situations or objects 35 .…”

Update in Nonoperative Management of Adolescent Idiopathic Scoliosis to Prevent Progression

“…28 Research on low-cost, quick-production 3D-printed braces is also underway. 29 In addition to radiographic and clinical measurements, the orthotist can utilize a three-dimensional optical scan of the patient to prepare the brace design. Minsk et al reported that patients with comparable deformity and brace-wear times were less likely to have curve progression or surgery when treated with a Cheneau-style orthosis than with a Boston-style orthosis.…”

Predicting spinal column profile from surface topography via 3D non-contact surface scanning

“…In certain healthcare applications, 3D surface scanning (3DSS) provides an appealing alternative to radiographic imaging due to its affordability, portability, ease of operation, and absence of ionising radiation exposure [ 5 ]. Examples of this application include evaluation of biomechanical and postural parameters, such as chest wall deformities [ 6 ], asymmetric muscular development [ 7 ], and measuring trunk posture for orthotic brace design [ 8 ]. An emerging application is the measurement of scoliosis severity by capturing surface topography of the torso to produce an external spinal contour [ 9 ].…”