Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression (PRISCOPRO)

February 20, 2025 updated by: Paul Gerdhem, Karolinska Institutet

3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Linköping, Sweden
        • Not yet recruiting
        • Linköping University Hospital
        • Contact:
          • Allan Abbott, PT, PhD
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Contact:
          • Elias Diarbakerli, PT, PhD
        • Contact:
          • Paul Gerdhem, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 3D TLSO
Brace treatment with Boston 3D 20 hours a day until skeletal maturity.
Other Names:
  • Boston 3D brace
Active Comparator: 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.
Device: Standard TLSO
Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.
Other Names:
  • Boston brace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: At each six-month follow-up and 2, 5, 10 years after skeletal maturity
Angle of trunk rotation in forward bending, assessed with scoliometer
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
Scoliosis Research Society-22r questionnaire
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
EQ5D questionnaire
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
Spinal Appearance Questionnaire (SAQ)
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
International Physical Activity Questionnaire (IPAQ)
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
Number needing surgical intervention
At each six-months follow-up and 2, 5, 10 years after skeletal maturity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Linkoeping University

Investigators

  • Principal Investigator: Elias Diarbakerli, PT, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

April 1, 2037

Study Registration Dates

First Submitted

March 13, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ED-PG-AA-2021-Brace

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD underlying published manuscripts will be accessible for other researchers.

IPD Sharing Time Frame

The study protocol will be submitted to a peer-reviewed journal.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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