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

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05001568
• Other study ID #: 20223437
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: St. Justine's Hospital
• Contact: n/a
• 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• 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

• Pregnancy

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

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.
• 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.
• 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.
• 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.

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