Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 5:35 AM
Study NCT ID:
NCT04282408
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Sponsor:
IRCCS Eugenio Medea
Organization:
Study Overview
Official Title:
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
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 proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta).
The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.
The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.
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?: