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

NCT04889339 | Unknown

• 1 other identifier: 2022-3437
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis; Adolescent Idiopathic Scoliosis

Keywords

Scoliosis; Spine deformity; Brace; Growth modulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline - 2 years

Secondary Outcomes (3)

• Treatment failure rate

  Baseline, 2 years

• Quality of Life (QoL)

  Baseline, 2 years

• Immediate in-brace Cobb angle

  5 minutes after brace fitting

Study Arms (2)

Test group: Braces designed with growth modulation simulation

EXPERIMENTAL

The braces will be designed using a growth modulation method.

Device: Test brace versus control brace: Immediate correction; Device: Test brace versus control brace: Long-term correction

Control group: Conventional method

ACTIVE COMPARATOR

The braces will be designed by an orthotist without growth modulation simulation.

Device: Test brace versus control brace: Immediate correction; Device: Test brace versus control brace: Long-term correction

Interventions

Test brace versus control brace: Immediate correction DEVICE

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.

Control group: Conventional method; Test group: Braces designed with growth modulation simulation

Test brace versus control brace: Long-term correction DEVICE

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.

Control group: Conventional method; Test group: Braces designed with growth modulation simulation

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• AIS diagnosis
• Risser 0-2
• Primary curve angles 20 degrees - 40 degrees
• If female, either premenarchal or less than 18 months postmenarchal.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Hubert Labelle, MD

CONTACT

+1514 345-4931; hubert.labelle@umontreal.ca

Soraya Barchi

CONTACT

+1514 345-4931; soraya.barchi@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedist, researcher

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 17, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

CA (1)