Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D TLSO, Standard TLSO.
- Who it may be relevant to
- Registry conditions: Idiopathic Scoliosis. Basic parameters: 9 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial
Overview
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.
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 for adolescents during a vulnerable stage in life, and may be associated with poor compliance. Furthermore, the treatment lasts in many cases for several years and has shown to have a negative psychological effect for patients. Since time in brace is of utmost importance for best possible outcome, the braces need to be tolerated by the patients. As of today, 3D designed braces have received much attention and are thought to increase comfortability and ultimately increase wearing time, leading to better outcomes.
In a multicenter randomized controlled trial, we seek to compare standard Boston brace to a newly developed 3D designed Boston brace. Skeletally immature patients with idiopathic scoliosis will be randomized to receive either standard Boston brace or Boston 3D brace. All patients will be encouraged to be physically active for 60 minutes per day. Patients, outcome assessors and clinician in charge during follow-ups will be blinded for the type of brace the patients are being treated with. Thermal sensors will be installed in all braces to monitor compliance. Outcome include change in curve severity, quality of life and surgical rates. Patients will be evaluated with clinical and radiological follow-ups every six months until skeletal maturity and thereafter at 2, 5 and 10 years. Curve progression will not lead to change of brace. A total of 85 individuals are required in each group based on the hypothesis of a 2% failure rate in the 3D-brace group and 15% in the standard brace group with 5% significance level and 80% power and consideration for dropout of up to 20%.
For individuals who are not willing to be randomized and participate in the study, standard Boston brace will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer same survey as the study populations will do.
Interventions
- Device 3D TLSO
Brace treatment with Boston 3D 20 hours a day until skeletal maturity. - Device Standard TLSO
Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.
Primary outcome measures
- Curve progression [Time frame: Measured at each six-month follow-up until skeletal maturity. Skeletal maturity defined as less than 1 cm body height increase in 6 months.]
Secondary outcome measures (6)
- Clinical outcomes [Time frame: At each six-month follow-up and 2, 5, 10 years after skeletal maturity]
- Patient-reported outcome measures [Time frame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity]
- Patient-reported outcome measures [Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity]
- Patient-reported outcome measures [Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity]
- Patient-reported outcome measures [Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity]
- Surgical rates [Time frame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
- Previous spine surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Sweden · 2 centers
- Linköping university hospital — Linköping
- Karolinska university hospital — Stockholm
Publications
- Diarbakerli E, Charalampidis A, Abbott A, Gerdhem P. PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace. PLoS One. 2021 Aug 9;16(8):e0255264. doi: 10.1371/journal.pone.0255264. eCollection 2021. PMID 34370760
Identifiers
NCT: NCT04805437 · ED-PG-AA-2021-Brace