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

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ClinicalTrials.gov Identifier: NCT02051933
Recruitment Status : Terminated (Low accrual rate)
First Posted : January 31, 2014
Results First Posted : February 25, 2022
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Equinus Contracture Drug: Botulinum toxin type A Drug: sodium chloride Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Plafond (Pilon) Fractures: A Pilot Study
Study Start Date : January 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Fractures

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 Name: 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 Name: Normal Saline




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


Secondary Outcome Measures :
  1. Short Form-36 (SF-36)Health Related Quality of Life [ Time Frame: 6 month follow-up visit ]
    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)

  2. Short Form-36 (SF-36) Health Related Quality of Life [ Time Frame: 12 month follow-up visits ]
    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)

  3. Ankle Pain at 6 Month [ Time Frame: 6 month follow-up visit ]
    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.

  4. Ankle Pain at 12 Month [ Time Frame: 12 month follow-up visit ]
    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.

  5. Functional Status of the Ankle at 6 Month [ Time Frame: 6 month follow-up visit ]

    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. Functional Status of the Ankle at 12 Month [ Time Frame: 12 month follow-up visit ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051933


Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Madhav A Karunakar, MD Wake Forest University Health Sciences
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Informed Consent Form  [PDF] April 15, 2013

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02051933    
Other Study ID Numbers: 03-12-19B
First Posted: January 31, 2014    Key Record Dates
Results First Posted: February 25, 2022
Last Update Posted: April 21, 2022
Last Verified: February 2022
Keywords provided by Wake Forest University Health Sciences:
pilon
tibial plafond
botox
ankle dorsiflexion
ankle functionality
ankle range of motion
Additional relevant MeSH terms:
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Contracture
Equinus Deformity
Talipes
Clubfoot
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Foot Deformities, Acquired
Foot Deformities
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents