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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02285621
Other study ID # CIHR_259812
Secondary ID 259812
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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,

Study Design


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
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