Trials / Completed
CompletedNCT02285621
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- St. Justine's Hospital · Academic / Other
- Sex
- All
- Age
- 10 Years – 14 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2019-09-01
- Completion
- 2021-09-01
- First posted
- 2014-11-07
- Last updated
- 2021-11-24
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02285621. Inclusion in this directory is not an endorsement.