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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Scoliosis; Idiopathic Scoliosis
• Intervention / Treatment: Device: Immediate in-brace correction: Conventional Brace; Device: Immediate in-brace correction: Optimized Brace; Device: Long-term bracing: Optimized Brace; Device: Long-term bracing: Conventional Brace

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimized Providence brace; The braces will be designed using optimization and finite element analysis.	Device: Immediate in-brace correction: Conventional Brace; 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 (supine position) 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.; Device: Immediate in-brace correction: Optimized Brace; 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 (supine position) 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.; Device: Long-term bracing: Optimized Brace; 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.
Active Comparator: Conventional Providence brace; The braces will be designed by an orthotist using the conventional design method.	Device: Immediate in-brace correction: Conventional Brace; 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 (supine position) 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.; Device: Immediate in-brace correction: Optimized Brace; 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 (supine position) 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.; Device: Long-term bracing: Conventional Brace; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cobb angle	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.	Baseline, 1 year, 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, 1 year, 2 years
Quality of Life (QoL) - SRS-22r	The QoL will be measured using the Scoliosis Reasearch Society (SRS)-22r.	Baseline, 1 year, 2 years
Quality of Life (QoL) - MOBI	The QoL will be measured using the My Orthopedic Brace Inventory (MOBI) questionnaire.	1 year, 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 the patient in a supine position.	5 minutes after brace fitting

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Scoliosis; Spine deformity; Optimization; Nighttime brace
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 20223437

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No