NCT02736370已完成不适用
Early Weight Bearing for Bimalleolar and Trimalleolar Ankle Fractures Without Syndesmotic Disruption
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Functional Outcome Scores
研究概览
简要总结
The purpose of this observational study is to assess the rate of return to work, rate of return to activities, functional outcome measures and pain scores in operatively repaired rotational Bimalleolar and Trimalleolar (AO/OTA Classification of 44A and 44B) ankle fractures not requiring fixation of the syndesmosis and allowed early weight bearing on or before the first post-operative visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men and women ages of 18 and up
- •Closed, low-energy Bimalleolar and Trimalleolar rotational ankle fractures
- •Orthopaedic Trauma Association (OTA) classification of 44A and 44B
- •English speaking
- •Able and willing to consent
排除标准
- •Open fractures
- •OTA classification of 43 and 44C
- •Patients with diabetes mellitus
- •No other lower extremity injuries that would affect functional outcomes
- •Previous use of walking aides
- •Patients with paralysis or hemiplegia
- •Ankle fractures requiring syndesmotic repair
- •Ankle fractures requiring fixation of the posterior malleolar
- •Associated neurovascular injury
- •Problems maintaining follow up (homeless or not willing to return for follow up)
- •Pathological fractures
- •Prisoners
- •Patients not allowed to bear weight before the 6 week post-operative follow up visit
结局指标
主要结局
Functional Outcome Scores
时间窗: 12 months post operatively
During follow up visits functional outcomes scores will be assess using the Foot and Ankle Score and the PROMIS (Patient Reported Outcomes Measurement Information System) Mobility Measure questionnaires. These forms will be analyzed together to determine the patients functional outcomes.
次要结局
- Return to work(up to 12 months)
- Fracture Healing(up to 12 months)
- Pain Scores(12 months post operatively)
- Post operative complications(up to 12 months)
研究者
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