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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04889339
• Other study ID #: 2022-3437
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: January 2024

Study information

• Verified date: May 2021
• Source: St. Justine's Hospital
• Contact: Hubert Labelle, MD
• Phone: +1514 345-4931
• Email: hubert.labelle[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: January 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	CHU Sainte-Justine	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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, 2 years
Secondary	Quality of Life (QoL)	The QoL will be measured using the SRS-22r and MOBI questionnaire.	Baseline, 2 years
Secondary	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 an low-dose biplane radiographic system (EOS).	5 minutes after brace fitting