Bracing AdoleScent Idiopathic Scoliosis after skeletal maturity (BASIS 2): study protocol for a randomized controlled trial within a larger trial.
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Authors
Ridsdale, Katie
Swaby, Lizzie
Totton, Nikki
Perry, Daniel C
Mills, Andrew J
Cole, Ashley A
Turtle, Chris
Waterhouse, Simon
Heath, Charlotte
Wilson, Isabelle
Issue Date
2026-01-23
Type
Journal Article
Language
en
Keywords
Alternative Title
Abstract
Aims: Adolescent idiopathic scoliosis affects 0.2% to 0.5% of adolescents, often requiring bracing to reduce the risk of curve progression. While bracing is typically discontinued at skeletal maturity, significant curve progression can occur afterwards, potentially necessitating surgery. The Bracing AdoleScent Idiopathic Scoliosis (BASIS) 2 study, nested within the larger BASIS trial, aims to evaluate the efficacy of prolonged full-time and night-time bracing beyond skeletal maturity in reducing curve progression. The aim is to determine if six months of additional bracing at normal prescription, after skeletal maturity, significantly reduces curve progression and is acceptable to patients with adolescent idiopathic scoliosis who were successfully treated with bracing.
Methods: This multicentre, prospective, parallel group, pragmatic, open-label, randomized controlled superiority trial will recruit participants from the BASIS study who reach skeletal maturity with a curve < 50°. Participants will be randomized 1:1 to either continue bracing for six months or cease bracing immediately.
Outcomes: The primary outcome is curve progression from baseline to two years post-skeletal maturity. Secondary outcomes include radiological measures, patient bracing experience and any preferences, and cost-effectiveness. The sample size is estimated at 228 participants. Results will be disseminated through peer-reviewed publications, conference presentations, and to study participants.
Description
© 2026 Ridsdale et al. This is an open-access article distributed under the terms of the Creative Commons Attribution Non Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/
Citation
Risdale, K. et al. (2026) 'Bracing AdoleScent Idiopathic Scoliosis after skeletal maturity (BASIS 2): study protocol for a randomized controlled trial within a larger trial', Bone & Joint Open 7(1) pp. 130-137. Available At: https://doi.org/10.1302/2633-1462.71.bjo-2025-0241
Publisher
Bone & Joint Surgery
License
© 2026 Ridsdale et al.
Journal
Bone & joint open
Volume
7
Issue
1
PubMed ID
ISSN
2633-1462