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

NCT ID: NCT02285621

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2021-09-30

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

Conditions

Scoliosis; Adolescent Idiopathic Scoliosis (AIS)

Keywords

Scoliosis; Spine deformity; Brace; 3D

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Optimized brace

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

Group Type: EXPERIMENTAL

Optimized brace versus conventional Boston brace

Intervention Type: 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.

Standard brace

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

Group Type: ACTIVE_COMPARATOR

Optimized brace versus conventional Boston brace

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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,

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hubert Labelle, MD

Orthopedist, researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hubert Labelle, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 28770254 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26861663 (View on PubMed)

Other Identifiers

259812

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CIHR_259812

Identifier Type: -

Identifier Source: org_study_id