Clinical trial NCT04805437: Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
Official title: 3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: Idiopathic scoliosis
Randomized controlled trial
Brace
Orthosis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2021-03-18
Enrollment: 170
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Curve progression
timeFrame: 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 outcomes:
measure: Clinical outcomes
timeFrame: At each six-month follow-up and 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
measure: Surgical rates
timeFrame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping university hospital
city: Stockholm
country: Sweden
facility: Karolinska university hospital
Study officials:
affiliation: Karolinska Institutet
name: Elias Diarbakerli, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.