Status:
TERMINATED
A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Women and Children's Health Research Institute, Canada
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-16 years
Phase:
NA
Brief Summary
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine due to an unknown cause. Bracing is a proven non-surgical treatment for scoliosis. Our group developed an ultrasound...
Detailed Description
A randomized clinical trial with a total of 50 new brace candidates diagnosed with AIS from the Stollery Children's Hospital Scoliosis Clinic will be conducted in the next 2 years. Ethics approval (Pr...
Eligibility Criteria
Inclusion
- It is based on the standard SRS brace studies criteria: a) diagnosed with AIS and new to rigid spinal brace treatment, b) prescribed full-time brace wear (23 hours per day), c) primary Cobb angles 20°- 40°, d) age between 10 -16 years, e) Risser 0-2 (skeletally immature), f) if female either premenarchal or less than 1 year postmenarchal.
Exclusion
- no surgery
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03365804
Start Date
January 15 2018
End Date
December 31 2023
Last Update
June 13 2024
Active Locations (1)
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1
Stollery Children hospital
Edmonton, Alberta, Canada, T6G2B7