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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Hubert Labelle, MD, St. Justine's Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285621
First Posted: November 7, 2014
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hubert Labelle, MD, St. Justine's Hospital
  Purpose
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

Condition Intervention Phase
Scoliosis Adolescent Idiopathic Scoliosis (AIS) Other: Optimized brace versus conventional Boston brace Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hubert Labelle, MD, St. Justine's Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optimized brace
Test group: Patient will receive optimized brace (3D computer assisted design of the brace)
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.
Active Comparator: Standard brace
Control goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285621


Contacts
Contact: Hubert Labelle, Dr hubert.labelle@recherche-ste-justine.qc.ca
Contact: Soraya Barchi soraya.barchi@umontreal.ca

Locations
Canada, Quebec
CHU Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Soraya Barchi       soraya.barchi@umontreal.ca   
Contact: Stefan Parent, PhD       stefan.parent@umontreal.ca   
Principal Investigator: Hubert Labelle, Dr         
Sponsors and Collaborators
St. Justine's Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hubert Labelle, MD, Orthopedist, researcher, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT02285621     History of Changes
Other Study ID Numbers: CIHR_259812
259812 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
First Submitted: September 5, 2014
First Posted: November 7, 2014
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Hubert Labelle, MD, St. Justine's Hospital:
Scoliosis
Spine deformity
Brace
3D

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases