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临床试验/NCT03084263
NCT03084263撤回不适用

A Comparison Study of Arthroscopic Assisted Open Reduction Internal Fixation (AORIF) Versus Open Reduction Internal Fixation (ORIF) in Ankle Fractures: Does AORIF Improve Functional Outcomes?

Spectrum Health Hospitals2 个研究点 分布在 1 个国家开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Rate of Return to Sports

研究概览

简要总结

The objective of this study is to compare the functional outcomes of patients with ankle fractures treated by Arthroscopic assisted Open Reduction Internal Fixation (AORIF) versus Open Reduction Internal Fixation (ORIF).

详细描述

Prospective Randomized Clinical Trial evaluating patients with ankle fractures undergoing AORIF versus ORIF

Participants will be randomized into 2 different surgical groups, one group receiving only ORIF and the other group receiving AORIF.

As standard of care patients will follow up in the office at approximately 3 weeks, 6 weeks and 12 weeks post operatively. Patients will be immobilized in a splint and will be non-weight bearing until their 3 week post-op visit. At the 3 week post-op visit, the patient will be fitted in a boot, be instructed to begin self-directed ROM and to continue non-weight bearing. At the 6 week post-op visit, the patient will begin weight bearing in the boot.

In office study visit will occur at these same times. At each visit weight bearing status, return to sports, pain level, AOFAS and FAAM will be assessed. One additional study visit will be conducted over the phone or by mail at approximately one year post operatively and will consist of the FAAM.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Closed ankle fractures (44A, 44B, 44C)
  • Ages of 18-65
  • Men or women, including pregnant women
  • Willing to consent

排除标准

  • Open fractures
  • Other lower extremity injuries/conditions that affects functional outcomes
  • Problems maintaining follow up (homeless, not willing to return for follow up)
  • Prisoners
  • Unable to consent

结局指标

主要结局

Rate of Return to Sports

时间窗: 1 year

Compare Return to Sports rates between AORIF versus ORIF of ankle fractures.

Foot and Ankle Ability Measure (FAAM)

时间窗: 1 year

Compare FAAM scores between AORIF versus ORIF of ankle fractures.

American Orthopedic Foot and Ankle Score (AOFAS)

时间窗: 6 month

Compare AOFAS scores between AORIF versus ORIF of ankle fractures.

次要结局

  • Rates of Complications(1 year)
  • Pain Scores(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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