Comparison of Gait in Syndesmosis Injuries Treated With Screw Fixation vs Suture Button
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Gait parameter - Stance time
研究概览
简要总结
Injuries to the distal tibiofibular syndesmosis are common and occur in an estimated 25% of all rotational ankle fractures. Anatomic reduction of the syndesmosis has been associated with improved functional outcome as well as decreased rates of posttraumatic arthritis. Both screw fixation and suture fixation have become accepted standards of care for treatment of syndesmotic injuries. Recent literature would suggest trends favoring suture fixation over screw fixation with improved quality of syndesmotic reduction, postoperative range of motion, and improved maintenance of syndesmotic reduction. However, the evidence remains heterogeneous, and patient reported outcomes have failed to show a superiority of one method over the other. Additionally, there have been no studies that demonstrate objective gait outcomes comparing screw versus suture fixation for syndesmotic injuries.
详细描述
This will be a prospective randomized study. Patients with isolated rotational ankle injuries with syndesmotic instability will be randomized to either screw fixation or suture fixation for treatment of their syndesmotic injury. Patients will be followed postoperatively for one year following surgery with documentation of both clinical outcomes and subjective patient reported outcomes. Additionally, postoperative gait patterns will be measured and compared between patients who had syndesmotic injuries treated with screw fixation versus suture fixation
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •19 years of age and older
- •Isolated rotational ankle injury
- •Syndesmotic instability (determined either pre- or intra-operatively)
- •Length-stable fibula fracture pattern
排除标准
- •Open fracture
- •Length-unstable fracture pattern (including Maisonneuve fracture pattern)
- •Syndesmotic stability (determined either pre- or intra-operatively)
- •Lower extremity neuropathy
- •History of prior trauma or surgery to injured ankle
- •Non-ambulatory
- •Use of ambulatory assistive device prior to injury
结局指标
主要结局
Gait parameter - Stance time
时间窗: 1 year
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step width
时间窗: 1 Year
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Swing time
时间窗: 1 year
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Gait speed
时间窗: 1 year
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step length
时间窗: 1 year
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step time
时间窗: 1 year
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Double support time
时间窗: 1 year
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step length
时间窗: 3 months
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step length
时间窗: 6 months
Step length will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step width
时间窗: 3 months
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step width
时间窗: 6 months
Step width will be measured in meters. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step time
时间窗: 3 months
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Step time
时间窗: 6 months
Step time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Swing time
时间窗: 3 months
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Swing time
时间窗: 6 months
Swing time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Stance time
时间窗: 3 months
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Stance time
时间窗: 6 months
Stance time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Double support time
时间窗: 3 months
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Double support time
时间窗: 6 months
Double support time will be measured in seconds. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Gait speed
时间窗: 3 months
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
Gait parameter - Gait speed
时间窗: 6 months
Gait speed will be measured in meters per second. Participants will walk down the length of a gait mat and back (20 feet in length, one-way). Five passes will be completed and the results averaged. Data will be collected on the Zeno Walkway using PKMAS software.
次要结局
- Development of radiographic arthritis(6 weeks, 3 months, 6 months, and 1 year)
- Secondary procedures(1 year)
- Patient reported outcomes - Olerud-Molander Score(3 months, 6 months, and 1 year)
- Implant complications(6 weeks, 3 months, 6 months, and 1 year)
- Patient reported outcomes - PROMIS LE (Patient-Reported Outcomes Information System Lower Extremity)(3 months, 6 months, and 1 year)
- Time to fracture union(6 weeks, 3 months, 6 months, and 1 year)
- Maintenance of syndesmotic reduction(6 weeks, 3 months, 6 months, and 1 year)
- Postoperative wound complications(2 weeks, 6 weeks, 3 months, 6 months, and 1 year)
- Ankle range of motion(2 weeks, 6 weeks, 3 months, 6 months, and 1 year)