Health TrialsbyHealthPanel

Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

ConditionIdiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorKarolinska Institutet

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)

Previous spine surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D TLSO

    Device

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

  • Standard TLSO

    Device

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

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: 3D TLSOExperimental treatment 1 intervention
Group B: Standard TLSOActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Curve progression

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

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.

Secondary outcomes

1

Clinical outcomes

Angle of trunk rotation in forward bending, assessed with scoliometer

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

Patient-reported outcome measures

Scoliosis Research Society-22r questionnaire

Time frame
At each six-months follow-up and 2, 5, 10 years after skeletal maturity
3

Patient-reported outcome measures

EQ5D questionnaire

Time frame
At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
4

Patient-reported outcome measures

Spinal Appearance Questionnaire (SAQ)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Linkoeping University

Collaborator

Source ClinicalTrials.gov
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