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

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

September 30, 2019

Study Completion Date

September 30, 2021

Conditions
ScoliosisAdolescent Idiopathic Scoliosis (AIS)
Interventions
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.

Trial Locations (1)

H3T 1C5

CHU Sainte-Justine, Montreal

All Listed Sponsors
lead

St. Justine's Hospital

OTHER

NCT02285621 - Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis | Biotech Hunter | Biotech Hunter