Weight-Bearing Timing and Outcomes After Surgical Suture Button Repair of the Distal Tibiofibular Syndesmosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Measure of the syndesmotic change
研究概览
简要总结
A debate regarding ankle fracture fixation centers on time to weight bearing. Recent literature has supported immediate weight bearing in surgically stabilized ankle fractures. However, significant variation among orthopaedic surgeons persists, and weight bearing recommendations change when there is a syndesmotic disruption. There is very little literature on time to weight bearing, with most available series casting/immobilizing these injuries for 6 weeks after fixation. There is very little data examining post-operative weight bearing after syndesmotic stabilization, and the majority centers on screw fixation. The minimum time to weight bearing after an ankle fracture with syndesmotic fixation in the literature is 4 weeks, with most focusing on 6 to 12 weeks. Based on biomechanical data regarding suture button techniques, the investigators hypothesize that patients undergoing ankle fracture fixation plus suture button fixation of their syndesmotic disruption will be able to safely bear weight early (2 weeks) after surgery. The investigator's null hypothesis is that there will be no difference between early weight bearing (2 weeks), and late weight bearing (6 weeks) in terms of outcome, hardware failure, loss of reduction, and return to work.
Adult patients who have an ankle fracture with suspected syndesmotic disruption, requiring a suture button fixation operative intervention will be randomized into early (2 weeks post-surgically) weight-bearing status or delayed weight-bearing status (non-weight-bearing for 6 weeks following fixation).
Primary objective: Maintenance of ankle reduction at 1 year follow-up (measured by comparing immediate post-op CT and 1 year time-point CT).
Secondary Objectives: Pain scores, surgical experience, work productivity and activity impairment , AAOS foot and ankle scores (2w, 6w, 12w, 6m, 1y), use of assistive devices, range of motion, physical therapy requirement/length of use/compliance, post-operative protocol compliance, post-operative complications (wound healing, infection, implant failure, fracture healing).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Ankle fracture with suspected syndesmotic disruption that would likely be treated with suture button fixation operative intervention
- •Ability to ambulate preoperatively
排除标准
- •Younger than 18
- •Length unstable syndesmotic injury (i.e. Maisonneuve)
- •Neuropathic diabetics
- •325 pounds or more
- •Pregnant or lactating
- •End stage renal disease
- •Inability to follow commands (dementia, TBI, etc.)
- •Polytrauma patients
结局指标
主要结局
Measure of the syndesmotic change
时间窗: 1 year
Determined by comparing the 1-year, post-operative CT scan to the immediate post-operative CT scan of the injured ankle
次要结局
- Pain scores(2 weeks to 1 year)
- Surgical Experience (SSQ-8)(Day 0)
- Foot and ankle outcomes (AAOS)(2 weeks to 1 year)
- Work productivity and activity impairment (WPAI)(6 weeks to 1 year)
研究者
Kyle Schweser MD
Orthopaedic Trauma Surgeon, Assistant Professor
University of Missouri-Columbia