Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

NCT ID: NCT04805437

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2037-04-30

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.

Conditions

Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

3D TLSO

Intervention Type: DEVICE

Brace treatment with Boston 3D 20 hours a day until skeletal maturity.

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.

Group Type: ACTIVE_COMPARATOR

Standard TLSO

Intervention Type: DEVICE

Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.

Interventions

3D TLSO

Brace treatment with Boston 3D 20 hours a day until skeletal maturity.

Intervention Type: DEVICE

Standard TLSO

Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.

Intervention Type: DEVICE

Other Intervention Names

Boston 3D brace; Boston brace

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Paul Gerdhem

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elias Diarbakerli, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Linköping university hospital

Linköping, , Sweden

Site Status: NOT_YET_RECRUITING

Karolinska university hospital

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Elias Diarbakerli, PT, PhD

Role: CONTACT

elias.diarbakerli@sll.se

+460851770000

Paul Gerdhem, MD, PhD

Role: CONTACT

paul.gerdhem@uu.se

Facility Contacts

Allan Abbott, PT, PhD

Role: primary

Elias Diarbakerli, PT, PhD

Role: primary

Paul Gerdhem, MD, PhD

Role: backup

References

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.

Reference Type: DERIVED

PMID: 34370760 (View on PubMed)

Other Identifiers

ED-PG-AA-2021-Brace

Identifier Type: -

Identifier Source: org_study_id