Clinical trial NCT02051933: The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Pilon Fractures
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
Overall status: TERMINATED
Phase: NA
Conditions: Equinus Contracture
Keywords: pilon
tibial plafond
botox
ankle dorsiflexion
ankle functionality
ankle range of motion
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Ankle Dorsiflexion of Injured Extremity
timeFrame: 6 month follow-up visit
Secondary outcomes:
measure: Short Form-36 (SF-36)Health Related Quality of Life
timeFrame: 6 month follow-up visit
measure: Short Form-36 (SF-36) Health Related Quality of Life
timeFrame: 12 month follow-up visits
measure: Ankle Pain at 6 Month
timeFrame: 6 month follow-up visit
measure: Ankle Pain at 12 Month
timeFrame: 12 month follow-up visit
measure: Functional Status of the Ankle at 6 Month
timeFrame: 6 month follow-up visit
measure: Functional Status of the Ankle at 12 Month
timeFrame: 12 month follow-up visit
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Madhav A Karunakar, MD
role: PRINCIPAL_INVESTIGATOR
References: