Clinical Trial: A Randomized Controlled Trial Comparing Cheneau Brace and Conventional Underarm Thoracolumbosacral Orthosis for the Treatment of Adolescent Idiopathic Scoliosis (Japan)

Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062171) titled 'A Randomized Controlled Trial Comparing Cheneau Brace and Underarm Thoracolumbosacral Orthosis for Adolescent Idiopathic Scoliosis' on July 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Juntendo University

Condition: Condition - Adolescent Idiopathic Scoliosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To compare the treatment outcomes of the new Cheneau brace with those of the conventional underarm brace in patients with adolescent idiopathic scoliosis. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Patients with adolescent idiopathic scoliosis who are eligible for brace treatment will be randomly assigned to either a conventional underarm thoracolumbosacral orthosis or a Cheneau brace, which is widely used in Europe and North America, to compare the safety and efficacy of the two braces. Interventions/Control_2 - A button-shaped temperature sensor will be attached to each brace to objectively monitor brace compliance.

Eligibility: Age-lower limit - 10 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients aged 10 to 16 years at the time of informed consent. 2. Outpatients diagnosed with adolescent idiopathic scoliosis (AIS). 3. Patients who meet the indications for brace treatment, defined as a Risser grade of 4 or less, a Cobb angle of 25 degrees or greater (or 20 degrees or greater in premenarchal patients), and less than 2 years since menarche for postmenarchal patients. 4. Patients who are capable of providing informed consent and are able to provide written informed consent voluntarily. For patients younger than 18 years of age, written informed consent must also be obtained from a legally authorized representative. 5. Patients who, in the judgment of the principal investigator or sub-investigator, are considered suitable for participation in this study and for the evaluation of its efficacy and safety after consideration of the inclusion and exclusion criteria. Key exclusion criteria - 1. Patients with a Cobb angle of 40 degrees or greater. 2. Patients who do not provide written informed consent to participate in this randomized controlled trial. 3. Patients who have psychiatric disorders or lack the capacity to provide informed consent. 4. Patients who, in the judgment of the principal investigator, are considered unsuitable for participation in this study. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 01 Day Date of IRB - 2026 Year 04 Month 09 Day Anticipated trial start date - 2026 Year 07 Month 09 Day Last follow-up date - 2034 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071147

Disclaimer: Curated by HT Syndication.