Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-27 @ 5:10 PM
Study NCT ID:
NCT02051933
Status:
TERMINATED
Last Update Posted:
2022-04-21
First Post:
2013-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Plafond (Pilon) Fractures: A Pilot Study
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Botox
Brief Summary:
The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at the time of surgery for pilon fractures, will improve ankle range-of-motion and functionality.
Detailed Description:
To determine if the use of Botulinum toxin A intramuscular injections of the gastrocsoleus complex in patients with operatively treated tibial plafond fractures will result in:
1. increased ankle dorsiflexion when compared to controls
2. increased ankle functionality as measured by the FAAM, and quality of life as measured by the SF-36, when compared to controls
3. a higher proportion of patients achieving at least 10 degrees of dorsiflexion when compared to controls
1. increased ankle dorsiflexion when compared to controls
2. increased ankle functionality as measured by the FAAM, and quality of life as measured by the SF-36, when compared to controls
3. a higher proportion of patients achieving at least 10 degrees of dorsiflexion when compared to controls
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?: