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Idiopathic ScoliosisPRISCOPRONCT04805437

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

A study testing 3D TLSO and Standard TLSO in people with Idiopathic Scoliosis, run by Karolinska Institutet at 2 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 17 years
Conditions the study is for
Idiopathic Scoliosis
What is being tested?
3D TLSO and Standard TLSO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
2 sitesSweden
Study dates
30 Apr 2021to Apr 2037
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Elias Diarbakerli, PT, PhD contact

+460851770000

elias.diarbakerli@sll.se

Paul Gerdhem, MD, PhD contact

paul.gerdhem@uu.se

Sweden2 sites, 2 recruiting

  • Linköping university hospital

    Linköping

    Allan Abbott, PT, PhD

    Not yet recruiting

  • Karolinska university hospital

    Stockholm

    Elias Diarbakerli, PT, PhD

    Paul Gerdhem, MD, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
3D TLSO, Standard TLSO
Keywords
Idiopathic scoliosis, Randomized controlled trial, Brace, Orthosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D TLSODevice

    Also called Boston 3D brace

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

  • Standard TLSODevice

    Also called Boston brace

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

Study groups in NCT04805437
Study groupRoleWhat they receive
3D TLSOExperimentalA 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.
Receives: Device: 3D TLSO
Standard TLSOActive comparatorA 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.
Receives: Device: Standard TLSO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Curve progression

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

    Measured: 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)

  1. Clinical outcomes

    Angle of trunk rotation in forward bending, assessed with scoliometer

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

  2. Patient-reported outcome measures

    Scoliosis Research Society-22r questionnaire

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

  3. Patient-reported outcome measures

    EQ5D questionnaire

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

  4. Patient-reported outcome measures

    Spinal Appearance Questionnaire (SAQ)

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

  5. Patient-reported outcome measures

    International Physical Activity Questionnaire (IPAQ)

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

  6. Surgical rates

    Number needing surgical intervention

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start30 Apr 2021
  3. Primary completionSep 2027 (estimated)
  4. Study completionApr 2037 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805437
Sponsor's protocol ID
ED-PG-AA-2021-Brace
Acronym
PRISCOPRO
Status last verified
Aug 2026
First submitted
13 Mar 2021
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD underlying published manuscripts will be accessible for other researchers.

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.

    PubMed 34370760

Questions about this trial

What is this clinical trial studying?

A study testing 3D TLSO and Standard TLSO in people with Idiopathic Scoliosis, run by Karolinska Institutet at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elias Diarbakerli, PT, PhD (+460851770000, elias.diarbakerli@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04805437, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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