Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT02051933
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02051933
Study Brief:
Protocol Section:
NCT02051933