3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Linköping university hospital
NOT_YET_RECRUITING
Linköping
Karolinska university hospital
RECRUITING
Stockholm
Contact Information
Primary
Elias Diarbakerli, PT, PhD
elias.diarbakerli@sll.se
+460851770000
Backup
Paul Gerdhem, MD, PhD
paul.gerdhem@uu.se
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2037-04
Participants
Target number of participants: 170
Treatments
Experimental: 3D TLSO
A 3-dimensional Boston brace will be designed to the patient's individual type of scoliosis. In-brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time.
Active_comparator: Standard TLSO
A standard Boston brace will be designed to the patient's individual type of scoliosis. In brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time.
Related Therapeutic Areas
Sponsors
Collaborators: Linkoeping University
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov