Variations of orthopedic braces for treating scoliosis in growing children
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth: Efficacy Analysis of a Retrospective Cohort
This study looks at different types of braces for kids with scoliosis to see if changes in design and fit make them more comfortable and effective than the usual braces.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 470 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Istituto Scientifico Italiano Colonna Vertebrale Academic / other |
| Locations | 1 site (Milan, Mi) |
| Trial ID | NCT04904627 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the different construction methods of orthopedic braces used for treating idiopathic adolescent scoliosis and dorsal hyperkyphosis. It aims to analyze how variations in brace design, materials, and fitting techniques impact patient comfort and treatment efficacy. The study will retrospectively review patient data, including radiographs and compliance records, to assess the effectiveness of these variations. The goal is to determine if these stylistic changes have improved outcomes compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates are adolescents under 16 years with idiopathic scoliosis or dorsal hyperkyphosis who are prescribed to wear a brace for more than 18 hours a day.
Not a fit: Patients with secondary causes of scoliosis or a history of spinal fusion surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved brace designs that enhance comfort and treatment effectiveness for scoliosis patients.
How similar studies have performed: There is currently no published evidence correlating variations in brace design with efficacy, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Idiopathic adolescent scoliosis and/or dorsal hyperkyphosis, * age under 16 years at the start of observation, * brace prescription for more than 18 hours/day, * availability of radiographs of the entire spine while standing and in brace radiographs at 1 month or out of brace at 5 ± 2 months at the end growth after 48 hours without brace and at 1 year. * availability of compliance data * Risser between 0 and 4 at first assessment Exclusion Criteria: * All secondary causes of scoliosis * history of spinal fusion surgery * lack of one of the radiographic examinations required by the protocol
Where this trial is running
Milan, Mi
- Isico — Milan, Mi, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.