Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis

Scoliosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285621
• Other study ID #: CIHR_259812
• Secondary ID: 259812
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2021

Study information

• Verified date: November 2021
• 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. The design is made relatively corsets empirically, hence the relative efficiency of this treatment. Our team has developed innovative methods for design, optimization and computer aided manufacturing-based numerical simulation models customized to each patient, and a system of evaluation and adjustment of corsets. In this project, the investigators will evaluate the effectiveness of this platform customized treatment and demonstrate its clinical application

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2021
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• 10 years or older

• 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 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 (AIS)
• Scoliosis

Intervention

Other:
• Optimized brace versus conventional Boston brace
Surface topography using Inspeck cameras allows production of a 3D reconstruction of the patient's trunk, this reconstruction will help to produce the optimized brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an EOS imaging system to allow 3D reconstructions. The SRS-22r will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care. Ibuttons are installed in each brace and used to measure the compliance of the patient.

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, 6 months, 1 year
Secondary	Change in Scoliosis Research Society questionnaire (SRS-22r) scores	The SRS-22r questionnaire is available from SRS.org. It is a self-reported tools assessing self-image, function, pain, mental health with 5 questions each and satisfaction with care with 2 questions. A total score is also available based on all 22 questions.	Baseline, 6 months, 1 year
Secondary	Change in surface topography	Four optical scanners are used to capture full trunk images. Subjects are positioned in a standard frame, and reference points marked. Parameters quantifying the external back surface deformity are assessed.	Baseline, 6 months, 1 year