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

Not Applicable

• Conditions: Scoliosis; Adolescent Idiopathic Scoliosis

• Registration Number: NCT04889339
• Lead Sponsor: St. Justine's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Study Start: 2021-06
• Primary Completion: 2023-12
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Cobb angle	Baseline - 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Treatment failure rate	Baseline, 2 years	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
Immediate in-brace Cobb angle	5 minutes after brace fitting	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).
Quality of Life (QoL)	Baseline, 2 years	The QoL will be measured using the SRS-22r and MOBI questionnaire.

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada