ISRCTN63247077
Active, not recruiting
未知
Bracing Adolescent Idiopathic ScoliosIS (BASIS) Study – night-time versus full-time bracing in adolescent idiopathic scoliosis
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Sideways curvature of the spine (scoliosis)
- Sponsor
- Sheffield Children's NHS Foundation Trust
- Enrollment
- 780
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
- •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
Outcomes
Primary Outcomes
Not specified
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