Status:
RECRUITING
Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Linkoeping University
Conditions:
Idiopathic Scoliosis
Eligibility:
All Genders
9-17 years
Phase:
NA
Brief Summary
Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that require...
Detailed Description
Bracing with a rigid TLSO is gold-standard treatment in terms of halting progression of idiopathic scoliosis in skeletally immature adolescents and children. The treatment is cumbersome and demanding ...
Eligibility Criteria
Inclusion
- Cobb 25-40 degrees
- Skeletally immature, Sanders score of 6 or less and Risser 2 or less.
- Menarche status maximum one year in females
- Aged 9-17 years
- No previous brace treatment or surgery for scoliosis
- Apex of the primary curve at T7 or caudal
Exclusion
- Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
- Previous spine surgery
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2037
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04805437
Start Date
April 30 2021
End Date
April 1 2037
Last Update
February 21 2025
Active Locations (2)
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1
Linköping university hospital
Linköping, Sweden
2
Karolinska university hospital
Stockholm, Sweden