Validation of a New Optimized Nighttime Providence Brace for Personalized Treatment of Adolescent Idiopathic Scoliosis

Not Applicable

Active, not recruiting

• Conditions: Idiopathic Scoliosis; Scoliosis

• Registration Number: NCT05001568
• 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 optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Study Start: 2021-11-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• 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
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Cobb angle	Baseline, 1 year, 2 years	Radiographics will be gathered and analyzed to observe changes between time points. All out-of-brace 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, 1 year, 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
Quality of Life (QoL) - SRS-22r	Baseline, 1 year, 2 years	The QoL will be measured using the Scoliosis Reasearch Society (SRS)-22r.
Quality of Life (QoL) - MOBI	1 year, 2 years	The QoL will be measured using the My Orthopedic Brace Inventory (MOBI) questionnaire.
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 the patient in a supine position.

Trial Locations

Locations (1)

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