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

• Sponsor: St. Justine's Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04889339
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis; Adolescent Idiopathic Scoliosis	Device: Test brace versus control brace: Immediate correction; Device: Test brace versus control brace: Long-term correction	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study will be separated into two stages. Each patient will initially try a control brace and a test brace in a crossover study model to evaluate the immediate correction. Each patient will then use one brace from either the control arm or test arm to evaluate the long-term correction of the brace.The study will be separated into two stages. Each patient will initially try a control brace and a test brace in a crossover study model to evaluate the immediate correction. Each patient will then use one brace from either the control arm or test arm to evaluate the long-term correction of the brace.
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Validation of a New Generation of Orthopedic Brace for Treating Adolescent Idiopathic Scoliosis by Using Growth Modulation
• Anticipated Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test group: Braces designed with growth modulation simulation The braces will be designed using a growth modulation method.	Device: Test brace versus control brace: Immediate correction; 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.; Device: Test brace versus control brace: Long-term correction; 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: Control group: Conventional method The braces will be designed by an orthotist without growth modulation simulation.	Device: Test brace versus control brace: Immediate correction; 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.; Device: Test brace versus control brace: Long-term correction; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Quality of Life (QoL) [Baseline, 2 years]

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

3. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Sainte-Justine	Montreal	Quebec	Canada	H3T 1C5

Sponsors and Collaborators

• St. Justine's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hubert Labelle, MD, Orthopedist, researcher, St. Justine's Hospital
• ClinicalTrials.gov Identifier: NCT04889339
• Other Study ID Numbers: 2022-3437
• First Posted: May 17, 2021
• Last Update Posted: May 17, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hubert Labelle, MD, Orthopedist, researcher, St. Justine's Hospital: Scoliosis; Spine deformity; Brace; Growth modulation
• Additional relevant MeSH terms: Scoliosis

Study Results

No Results Posted as of May 17, 2021