Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04904627
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2021-05-12
Brief Title:
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth
Sponsor:
Istituto Scientifico Italiano Colonna Vertebrale
Organization:
Istituto Scientifico Italiano Colonna Vertebrale
Study Overview
Official Title:
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth Efficacy Analysis of a Retrospective Cohort
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 greater comfort for the patient The closure of the brace or the way in which the two shells are fixed varies at the discretion of the orthopedic technician Plastic materials have also changed In addition the use of the classic cast for the production of the negative model was gradually replaced by cad-cam technology In some cases modular constructions were introduced with respect to the customized one All this has changed the classic corsets over time even without changing their name type and according to the hypothesis that their effectiveness remained at least the same if not even improved
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None