Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT01375218
Status:
COMPLETED
Last Update Posted:
2015-01-19
First Post:
2011-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants
Sponsor:
OrthoCarolina Research Institute, Inc.
Organization:
Study Overview
Official Title:
Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2013-12
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 purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: