Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT01067651
Status:
COMPLETED
Last Update Posted:
2010-02-11
First Post:
2010-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method
Sponsor:
Alberta Children's Hospital
Organization:
Study Overview
Official Title:
Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2007-04
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 was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.
Detailed Description:
Congenital idiopathic clubfoot is the most common congenital deformity in children. It can be a major cause of disability for children, as well as an emotional stress for parents. The Ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now the gold standard of treatment. It has traditionally been described using plaster of Paris (POP) above-knee casts; however, recently semi-rigid fiberglass softcast (SRF, 3M Scotchcast) has grown in popularity. There are currently no randomized controlled trials to prove its efficacy with respect to POP.
Study Oversight
Has Oversight DMC:
False
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?: