Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation

St. Justine's Hospital58 enrolled

Overview

Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by simulating the growth modulation using numerical models. Those models are customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and validate its clinical application.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Scoliosis Adolescent Idiopathic Scoliosis

Interventions

The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.

Test brace versus control brace: Long-term correctionDEVICE

After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * AIS diagnosis * Risser 0-2 * Primary curve angles 20 degrees - 40 degrees * If female, either premenarchal or less than 18 months postmenarchal. Exclusion Criteria: * Patients with a pre-existing cardiovascular condition * Patients with a symptom of a neurological disorder * Patients with any other disorder of the musculoskeletal system affecting the lower limbs

Outcomes

Primary Outcomes

Change in Cobb angle

Radiographics will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.

Time frame: Baseline - 2 years

Secondary Outcomes

Treatment failure rate

Treatment failure is defined as having a Cobb angle progress by more than 5 degrees compared to the baseline measurement or exceeding a value of 45 degrees

Time frame: Baseline, 2 years

Quality of Life (QoL)

The QoL will be measured using the SRS-22r and MOBI questionnaire.

Time frame: Baseline, 2 years

Immediate in-brace Cobb angle

Radiographics will be gathered and analyzed to observe changes between the control and test braces. All radiographs will be taken with an low-dose biplane radiographic system (EOS).

Time frame: 5 minutes after brace fitting