The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures (Botox)

The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Plafond (Pilon) Fractures: A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Equinus Contracture
• Intervention / Treatment: Drug: Botulinum toxin type A; Drug: sodium chloride

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients 18 and older with a tibial plafond fracture to be treated by a staged protocol involving primary external fixation and definitive fixation within 3 weeks from the injury.

(Non-definitive, interval procedures such as repeat irrigation and debridement and fibular fixation are allowed.)

Exclusion Criteria:

• Younger than 18 years of age
• Significant traumatic brain injury or cognitive disability that would interfere with post-operative rehabilitation and study questionnaires
• Nerve, vascular, or tendon injury of the lower leg: injury to the tibial or peroneal motor nerves, injury to the posterior tibial artery requiring repair, or laceration of tendons that are involved in plantar flexion or dorsiflexion of the ankle which require repair
• History of prior lower extremity fracture to the tibia or ankle of the affected limb.
• Incarcerated patients.
• Patients unable or unwilling to return for follow-up examination.
• Pregnant or lactating patients.
• History of disease affecting the neuromuscular junction (ex: myasthenia gravis).
• Use of aminoglycoside antibiotics at the time of definitive fixation.
• Ipsilateral foot injury that will impair dorsiflexion exercises: Lisfranc injuries, fractures or dislocations of the talus, calcaneus, navicular, cuboid, cuneiforms, or metatarsals (phalanx fractures or dislocations will not be excluded).
• Patients receiving Botulinum Toxin A for other reasons.
• Patients with a known hypersensitivity to Botulinum toxin A.
• Gustilo Anderson type III B and C.
• Patients with a weight greater than 115 kg - to ensure proper injection locations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botox; Botox: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U	Drug: Botulinum toxin type A; At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U; Other Names: Botox
Placebo Comparator: Placebo; Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U	Drug: sodium chloride; At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U; Other Names: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Dorsiflexion of Injured Extremity	The difference in ankle dorsiflexion between the injured and un-injured ankles as measured with goniometer 6 month from surgery.	6 month follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Form-36 (SF-36)Health Related Quality of Life	The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)	6 month follow-up visit
Short Form-36 (SF-36) Health Related Quality of Life	The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)	12 month follow-up visits
Ankle Pain at 6 Month	Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.	6 month follow-up visit
Ankle Pain at 12 Month	Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.	12 month follow-up visit
Functional Status of the Ankle at 6 Month	The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.	6 month follow-up visit
Functional Status of the Ankle at 12 Month	The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. A higher score represents a higher level of physical function.	12 month follow-up visit

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Madhav A Karunakar, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 14, 2013
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: botox; ankle dorsiflexion; pilon; tibial plafond; ankle functionality; ankle range of motion
• Additional Relevant MeSH Terms: Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity; Contracture; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: 03-12-19B