Clinical Trial: The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Plafond (Pilon) Fractures: A Pilot Study
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 Summary:
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:
- increased ankle dorsiflexion when compared to controls
- increased ankle functionality as measured by the FAAM, and quality of life as measured by the SF-36, when compared to controls
- a higher proportion of patients achieving at least 10 degrees of dorsiflexion when compared to controls
Sponsor: Carolinas Healthcare System
Current Primary Outcome: Change in Ankle Dorsiflexion of Injured Extremity [ Time Frame: 6 and 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Health Related Quality of Life [ Time Frame: 6 month and 12 month follow-up visits ]SF-36 will be used to measure health-related quality of life.
- Change in Pain [ Time Frame: 6 month and 12 month follow-up visits ]Overall study limb, as well as ankle specific, pain intensity will be measured using the 0-10 visual analog scale used in the Brief Pain Inventory
- Change in functional status of the Ankle [ Time Frame: 6 month and 12 month follow-up visits ]The FAAM will be obtained to assess the functional status of the affected ankle.
Original Secondary Outcome: Same as current
Information By: Carolinas Healthcare System
Dates:
Date Received: October 14, 2013
Date Started: January 2013
Date Completion: January 2020
Last Updated: February 10, 2016
Last Verified: February 2016