Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

NCT04805437 | Recruiting

• 1 other identifier: ED-PG-AA-2021-Brace
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

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.

Conditions

Idiopathic Scoliosis

Keywords

Idiopathic scoliosis; Randomized controlled trial; Brace; Orthosis

Outcome Measures

Primary Outcomes (1)

• Curve progression

  Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive radiographs after baseline

  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 (6)

• Clinical outcomes

  At each six-month follow-up and 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-months follow-up and 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-month follow-up, and 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-month follow-up, and 2, 5, 10 years after skeletal maturity

• Patient-reported outcome measures

  At each six-month follow-up, and 2, 5, 10 years after skeletal maturity

Study Arms (2)

3D TLSO

EXPERIMENTAL

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.

Device: 3D TLSO

Standard TLSO

ACTIVE COMPARATOR

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.

Device: Standard TLSO

Interventions

3D TLSO DEVICE

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

Also known as: Boston 3D brace

3D TLSO

Standard TLSO DEVICE

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

Also known as: Boston brace

Standard TLSO

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
• Previous spine surgery

Sponsors & Collaborators

• Karolinska Institutet: lead
• Linkoeping University: collaborator

Study Sites (2)

Linköping university hospital

Linköping, Sweden

NOT YET RECRUITING

Karolinska university hospital

Stockholm, Sweden

RECRUITING

Related Publications (1)

• 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 DERIVED

Study Officials

• Elias Diarbakerli, PT, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elias Diarbakerli, PT, PhD

CONTACT

+460851770000; elias.diarbakerli@sll.se

Paul Gerdhem, MD, PhD

CONTACT

paul.gerdhem@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Orthotist and research nurse will know what type of brace the participant receives, but will not tell the participant which type he/she has received. Investigators, care providers and outcome assessors will be blinded for type of brace.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 18, 2021
• Study Start: April 30, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2037
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol will be submitted to a peer-reviewed journal.
• Access Criteria: The investigators in charge will be responsible for reviewing access requests. Crude data, randomization procedures and intervention details can be shared with other researchers upon request.

Locations

SE (2)