Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Olerud Molander Ankle Score
研究概览
简要总结
The purpose of this randomized, controlled trial is to estimate the safety of early weight bearing on post ankle surgery.
Patients who are indicated to have surgery for unstable ankle fractures by an attending trauma physician will be consented for participation in the study. After surgery patients will be randomized to either weight bearing as tolerated at two weeks with a cam boot or non-weight bearing with a cam boot. Randomization will be performed by number allocation with odd numbers in the early weight bearing group and even numbers in the non-weight bearing group. The surgeon will be blinded to this until after the surgery. The patients will all be placed in a short leg cast post operative and made non-weight bearing for 2 weeks until sutures are removed which is current standard treatment. Both groups will be asked to initiate weight bearing at two weeks post operatively by wearing a cam boot that is non weight bearing in a cam boot, the latter being standard treatment.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Operative unstable ankle fractures
排除标准
- •Requirement of syndesmotic fixation
- •Pilon fractures
- •Open fractures
- •Patients with diabetic neuropathy
- •Polytrauma patients
- •Patients who are unable to comply with non-weight bearing
- •Patients who are unable to follow up
结局指标
主要结局
Olerud Molander Ankle Score
时间窗: 1 year
The Olerud Molander score is scored between 0 - 100 as painless and functionally perfect ankle.
次要结局
未报告次要终点
