Actively Recruiting
Led by Karolinska Institutet · Updated on 2025-02-21
170
Participants Needed
2
Research Sites
500 weeks
Total Duration
K
Karolinska Institutet
Lead Sponsor
L
Linkoeping University
Collaborating Sponsor
Idiopathic scoliosis is a common spinal deformity in children and adolescents, affecting about 3% of this population. Approximately 10% of these children develop a curve severe enough to require treatment with a brace or surgery. Researchers are investigating whether a newly developed 3D designed Boston brace can improve comfort and wearing time compared to the standard Boston brace, as wearing time is crucial for treatment success. This study is a multicenter randomized controlled trial aiming to compare these two braces in skeletally immature patients with idiopathic scoliosis. Participants will be randomly assigned to wear either the standard Boston brace or the new 3D designed Boston brace. Both braces are designed to be worn for 20 hours or more per day until the patient reaches skeletal maturity. Patients are encouraged to maintain 60 minutes of physical activity daily. Compliance with wearing the brace will be monitored using a built-in thermal sensor. Follow-ups with clinical and radiological evaluations will occur every six months until skeletal maturity, then at 2, 5, and 10 years afterward. An observational group will include patients who choose not to be randomized but will receive the standard brace and similar follow-ups. During the study, participants will have in-brace radiographs after brace prescription and regular reassessments every six months. The research team will monitor curve progression, quality of life, and surgical rates as outcome measures. Wearing compliance will be tracked continuously by the thermal sensors. The study will continue until skeletal maturity, defined as less than 1 cm of height growth in six months, with long-term follow-up extending up to 10 years after maturity. A total of 85 participants per group are planned to ensure statistical power while considering possible dropouts.
CONDITIONS
Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until skeletal maturity
Participants are assigned to wear either a 3D designed Boston brace or a standard Boston brace for 20 hours per day until skeletal maturity. They will be encouraged to remain physically active for 60 minutes daily. Compliance will be monitored with a heat sensor in the brace. Clinical and radiological evaluations occur regularly to assess curve progression and other outcomes.
Clinical and radiological follow-ups every 6 months
Duration - Up to 10 years after skeletal maturity
After skeletal maturity, participants will continue clinical, radiological, and patient-reported assessments to monitor long-term outcomes including curve progression, quality of life, and surgical rates.
Follow-up visits at 2, 5, and 10 years after skeletal maturity
Total: 2 locations
1
Linköping university hospital
Linköping, Sweden
Not Yet Recruiting
2
Karolinska university hospital
Stockholm, Sweden
Actively Recruiting
E
Elias Diarbakerli, PT, PhD
P
Paul Gerdhem, MD, PhD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Elias Diarbakerli, Anastasios Charalampidis, Allan Abbott...
https://pubmed.ncbi.nlm.nih.gov/34370760