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OpenTrials
Completed

NCT Number: NCT02285621

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

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

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Key information

Conditions

Scoliosis Adolescent Idiopathic Scoliosis (AIS) Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Optimized brace versus conventional Boston brace

Other

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.

Primary outcomes

  1. Change in Cobb angle

    Time frame: Baseline, 6 months, 1 year

    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.

Secondary outcomes

  1. Change in Scoliosis Research Society questionnaire (SRS-22r) scores

    Time frame: Baseline, 6 months, 1 year

    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.

  2. Change in surface topography

    Time frame: Baseline, 6 months, 1 year

    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.

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2021
First posted
Nov 7, 2014
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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