The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Plafond (Pilon) Fractures: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Ankle Dorsiflexion of Injured Extremity
研究概览
简要总结
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.
详细描述
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:
- increased ankle dorsiflexion when compared to controls
- increased ankle functionality as measured by the FAAM, and quality of life as measured by the SF-36, when compared to controls
- a higher proportion of patients achieving at least 10 degrees of dorsiflexion when compared to controls
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
排除标准
- •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
研究组 & 干预措施
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
干预措施: Botulinum toxin type A (Drug)
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
干预措施: sodium chloride (Drug)
结局指标
主要结局
Ankle Dorsiflexion of Injured Extremity
时间窗: 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.
次要结局
- Ankle Pain at 12 Month(12 month follow-up visit)
- Functional Status of the Ankle at 6 Month(6 month follow-up visit)
- Functional Status of the Ankle at 12 Month(12 month follow-up visit)
- Short Form-36 (SF-36) Health Related Quality of Life(12 month follow-up visits)
- Short Form-36 (SF-36)Health Related Quality of Life(6 month follow-up visit)
- Ankle Pain at 6 Month(6 month follow-up visit)