NCT02285621

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

6 years

First QC Date

September 5, 2014

Last Update Submit

November 23, 2021

Conditions

ScoliosisAdolescent Idiopathic Scoliosis (AIS)

Keywords

ScoliosisSpine deformityBrace3D

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    Baseline, 6 months, 1 year

  • Change in surface topography

    Baseline, 6 months, 1 year

Study Arms (2)

Optimized brace

EXPERIMENTAL

Test group: Patient will receive optimized brace (3D computer assisted design of the brace)

Other: Optimized brace versus conventional Boston brace

Standard brace

ACTIVE COMPARATOR

Control goup: Patient will receive the Boston Thoracolumbosacral orthosis (TLSO) (conventional design method)

Other: Optimized brace versus conventional Boston brace

Interventions

Optimized brace versus conventional Boston braceOTHER

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.

Optimized braceStandard brace

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (2)

  • Cobetto N, Aubin CE, Parent S, Barchi S, Turgeon I, Labelle H. 3D correction of AIS in braces designed using CAD/CAM and FEM: a randomized controlled trial. Scoliosis Spinal Disord. 2017 Jul 23;12:24. doi: 10.1186/s13013-017-0128-9. eCollection 2017.

    PMID: 28770254DERIVED

  • Cobetto N, Aubin CE, Parent S, Clin J, Barchi S, Turgeon I, Labelle H. Effectiveness of braces designed using computer-aided design and manufacturing (CAD/CAM) and finite element simulation compared to CAD/CAM only for the conservative treatment of adolescent idiopathic scoliosis: a prospective randomized controlled trial. Eur Spine J. 2016 Oct;25(10):3056-3064. doi: 10.1007/s00586-016-4434-3. Epub 2016 Feb 9.

    PMID: 26861663DERIVED

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Hubert Labelle, MD

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedist, researcher

Study Record Dates

First Submitted

September 5, 2014

First Posted

November 7, 2014

Study Start

September 1, 2013

Primary Completion

September 1, 2019

Study Completion

September 1, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

CA(1)