Status:
RECRUITING
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth
Lead Sponsor:
Istituto Scientifico Italiano Colonna Vertebrale
Conditions:
Scoliosis
Eligibility:
All Genders
Up to 16 years
Brief Summary
The construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure...
Eligibility Criteria
Inclusion
- 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
- All secondary causes of scoliosis
- history of spinal fusion surgery
- lack of one of the radiographic examinations required by the protocol
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT04904627
Start Date
July 1 2021
End Date
December 1 2024
Last Update
May 8 2024
Active Locations (1)
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1
ISICO
Milan, Mi, Italy, 20141