Effectiveness of Three Dimensional Correction During in Bracing in Adolescent Idiopathic Scoliosis: a Prospective Randomised Clinical Trial of Rigo Chêneau Versus Boston-style Orthoses

UW 20-243

The purpose of this study is to study the effectiveness of in-brace 3D scoliosis correction by comparing Rigo Chêneau orthoses (RCO) with conventional Traditional Boston-style thoracolumbosacral orthoses (TLSO) in Adolescent Idiopathic Scoliosis (AIS) patients, following Scoliosis Research Society (SRS) and The International Scientific Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) recommendations for non-operative AIS management and research studies. This group of patients that reach the threshold for bracing have an intrinsic higher risk for curve progression. Hence, the proposed study will provide novel and high quality evidence to improve the efficacy of bracing in the non-operative treatment of AIS. This will contribute significantly to the betterment of public health by reducing the number of patients requiring surgical intervention. Ultimately, new evidence-based clinical practice guidelines on the most effective type of scoliosis braces will benefit children diagnosed with AIS worldwide.

2022-07-02

2025-07-03

2025-12-03

Recruiting

134

Inclusion Criteria: * Diagnosis of AIS * Male or female from 10 to 15 year-old, inclusive, at the time of consent provided * Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual fusion of the iliac apophysis) of 0, 1, or 2 * Cobb angle of 25-40 * No prior conservative or surgical treatment for AIS Exclusion Criteria: * An underlying cause or association that may cause scoliosis * Leg length discrepancies or lower limb deformities that may interfere with spinal posture * Previous spinal surgery * Cognitive impairment * Those receiving any other forms of treatment including alternative medicine for the treatment of their scoliosis * Those who are unable to return for follow-up to complete the trial

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Patients diagnosed with AIS referred for bracing through the hospital's specialist outpatient clinic are eligible to enrol the study. The Investigator will document whether each patient meets the selection criteria before enrolment into the study. The Investigator or designee will also obtain an IRB/EC approved Informed consent from each patient and/or guardian.\n\nEligible patients will be randomly assigned to either RCO group (experimental) or TLSO group (control) in a ratio of 1:1. The radiographic evaluation, physical examination and PROM questionnaires will be assessed at baseline, 3 months, 6 months, 12 months and every year until patients reach skeletal maturity or if surgical intervention is required.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Assessor, statistician and investigator blinded', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 134, 'type': 'ESTIMATED'}}

2023-02-06