BASIS Study - Comparing night-time versus full-time bracing in adolescent scoliosis (sideways curvature of the spine)

Not Applicable

Conditions: Sideways curvature of the spine (scoliosis)
Musculoskeletal Diseases
Scoliosis

Registration Number: ISRCTN63247077

Lead Sponsor: Sheffield Children's NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 780

Inclusion Criteria

1. Children (10–15 years old inclusive) with a diagnosis of AIS; (some patients recruited at age 15 may be 19 years old by the time they have completed their 2 years after skeletal maturity follow-up)
2. Risser 0, 1 or 2
3. Curve size (Cobb angle) between 20 and 40 degrees inclusive at baseline
4. Curve apex at or below T7
5. Participants and their parent/legal guardian must have a good understanding of the English language to ensure they understand what is required as part of the trial

Added 14/05/2024:
BASIS 2:
1. Participants enrolled on the BASIS study
2. RAC confirms skeletal maturity (Risser 4 in girls, Risser 5 in boys) with a Cobb angle less than 50o

Exclusion Criteria

1. Secondary causes of scoliosis (i.e. neurological abnormalities and abnormal imaging)
2. Previous bracing or spinal surgery
3. Child or parent is unable to adhere to trial procedures or complete follow-up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Curve progression is measured using the Cobb angle (measured from x-ray), every 6 months, before skeletal maturity, and then at 1 and 2 years post skeletal maturity.<br><br>Added 14/05/2024:<br>BASIS 2:<br>Curve progression from baseline to 2 years after skeletal maturity, in degrees. These will be assessed by the Central Measurement Team.

Secondary Outcome Measures