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



Status:Terminated
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:January 2013
End Date:January 2020

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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.

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

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
We found this trial at
1
site
1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
?
mi
from
Charlotte, NC
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