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

Primary Purpose

Equinus Contracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Botulinum toxin type A
sodium chloride
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Equinus Contracture focused on measuring pilon, tibial plafond, botox, ankle dorsiflexion, ankle functionality, ankle range of motion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Botox

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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.
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.
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.
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.

Full Information

First Posted
October 14, 2013
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02051933
Brief Title
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures
Acronym
Botox
Official Title
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Plafond (Pilon) Fractures: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Low accrual rate
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Equinus Contracture
Keywords
pilon, tibial plafond, botox, ankle dorsiflexion, ankle functionality, ankle range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
Botox
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
sodium chloride
Other Intervention Name(s)
Normal Saline
Intervention Description
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
Primary Outcome Measure Information:
Title
Ankle Dorsiflexion of Injured Extremity
Description
The difference in ankle dorsiflexion between the injured and un-injured ankles as measured with goniometer 6 month from surgery.
Time Frame
6 month follow-up visit
Secondary Outcome Measure Information:
Title
Short Form-36 (SF-36)Health Related Quality of Life
Description
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)
Time Frame
6 month follow-up visit
Title
Short Form-36 (SF-36) Health Related Quality of Life
Description
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)
Time Frame
12 month follow-up visits
Title
Ankle Pain at 6 Month
Description
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.
Time Frame
6 month follow-up visit
Title
Ankle Pain at 12 Month
Description
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.
Time Frame
12 month follow-up visit
Title
Functional Status of the Ankle at 6 Month
Description
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.
Time Frame
6 month follow-up visit
Title
Functional Status of the Ankle at 12 Month
Description
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.
Time Frame
12 month follow-up visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhav A Karunakar, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

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

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