Bracing AdoleScent Idiopathic Scoliosis after skeletal maturity (BASIS 2): study protocol for a randomized controlled trial within a larger trial

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.