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:

  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

Sponsor: Carolinas Healthcare System

Current Primary Outcome: Change in Ankle Dorsiflexion of Injured Extremity [ Time Frame: 6 and 12 months ]

The primary outcome variable will be ankle dorsiflexion of the injured extremity as measured by equinometer device using a constant torque (10Nm) with knee fully extended and at 90 degrees of flexion.


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