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?
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
- 否
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)
