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Clinical Trials/ISRCTN63247077
ISRCTN63247077
Active, not recruiting
未知

Bracing Adolescent Idiopathic ScoliosIS (BASIS) Study – night-time versus full-time bracing in adolescent idiopathic scoliosis

Sheffield Children's NHS Foundation Trust0 sites780 target enrollmentApril 19, 2021

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.

Registry
who.int
Start Date
April 19, 2021
End Date
October 31, 2032
Last Updated
last year
Study Type
Interventional
Sex
All

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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