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

Not Applicable

Terminated

Conditions: Equinus Contracture

Interventions: Drug: Botulinum toxin type A
Drug: sodium chloride

Registration Number: NCT02051933

Lead Sponsor: 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.

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

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 10

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox	Botulinum toxin type A	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	sodium chloride	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

Primary Outcome Measures

Name	Time	Method
Ankle Dorsiflexion of Injured Extremity	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

Name	Time	Method
Ankle Pain at 12 Month	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.
Functional Status of the Ankle at 6 Month	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.
Functional Status of the Ankle at 12 Month	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.
Short Form-36 (SF-36) Health Related Quality of Life	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)
Short Form-36 (SF-36)Health Related Quality of Life	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)
Ankle Pain at 6 Month	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.