跳至主要内容
临床试验/NCT02779244
NCT02779244已完成不适用

Early Weight Bearing for Unstable Ankle Fractures Undergoing Operative Stabilization: Is It Safe and Does It Improve Outcomes?

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2017年9月1日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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