Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorKarolinska Institutet

About this trial

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 requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

Eligibility criteria

Qualifiers

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

Disqualifiers

Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)

Previous spine surgery

Trial design

Treatments tested in this trial

  • 3D TLSO
  • Standard TLSO

Treatment groups

170 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Linkoeping University

Collaborator