Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth
NCT ID: NCT04904627
Last Updated: 2024-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
470 participants
OBSERVATIONAL
2021-07-01
2024-12-31
Brief Summary
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There are no publications that have shown variations in efficacy that can be correlated with some of these stylistic variations.
The purpose of this study is to retrospectively investigate whether the various innovations and stylistic variations over time have had an effect on the clinical, functional and radiographic outcomes in growing subjects suffering from spinal deformity treated with corsets at a specialized center.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Polyehtylene vs Poliìycarbonate
super rigid vs rigid material
No interventions assigned to this group
Free pelvis vs classic pelvis
fixed pelvis versus free pelvis, allowing adjustment in the sagittal plane.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* history of spinal fusion surgery
* lack of one of the radiographic examinations required by the protocol
16 Years
ALL
No
Sponsors
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Istituto Scientifico Italiano Colonna Vertebrale
OTHER
Responsible Party
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Locations
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ISICO
Milan, Mi, Italy
Countries
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Facility Contacts
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Other Identifiers
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COB-ISICO
Identifier Type: -
Identifier Source: org_study_id
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