Recovery Following Ankle Fracture Reported by Patient Report Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Self-reported foot and ankle questionnaire (SEFAS)
研究概览
简要总结
Ankel fractures is a common fracture. Most patients experience that the regain normal range of motions and limited pain within the first 6 months following ankel fracture, but not all. The aim of the study is to determine if any prognostic factors is associated with a worse outcome.
详细描述
Aim of study:
To identify prognostic factors associated with a worse outcome following ankle fractures.
Method:
All operated or non-operated ankle fractures in a period of one year from three different hospitals will be included. The following data will be recorded:
Civil registration number, age, rupture of the syndesmosis, use of alcohol, smoking, diabetes, characteristics of the ankle fracture (AO classification), type of treatment and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All patients with ankle fracture.
排除标准
- •age below 18 years
- •patients who do not speak or understand danish
- •mental disable patients
结局指标
主要结局
Self-reported foot and ankle questionnaire (SEFAS)
时间窗: 2 years
The Self-reported foot and ankle questionnaire (SEFAS) comprises twelve items relating to pain, limping, swelling, use of orthotics and walking. Response scales vary from 1 to 5, 1 being the most severe response. Item responses are summed to give a score from 12-60, with higher scores representing the best possible.
Olerud Molander Ankle Score (OMAS)
时间窗: 2 years
The Olerud Molander Ankle Score (OMAS) comprises nine items relating to symptoms, physical function and daily activities. The response scales vary from binary to five-points with clinical scoring that reflects the level of disability for individual items. Item responses are summed to give a score from 0 to 100 with higher scores representing the best possible
Forgotten Joint Score (FJS)
时间窗: 2 years
The forgotten Joint Score (FJS) is a 12-item questionnaire concerning the participiants awareness of their artificial joint during ADL. For each question, the participant can choose between 6 response options: never, almost never, seldom, sometimes, mostly, or not relevant for me. All responses are summed from 0-4 with a total score from 0-100 with higher scores representing the worse possible
Manchester foot and ankle questionnaire (MOXFQ)
时间窗: 2 years
Manchester foot and ankle questionnaire (MOXFQ) a Patient reported outcome measure. The MOXFQ contains 16 items, each with five response options, comprising three dimensions: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items), including feelings of self consciousness about foot/footwear appearance. Responses are each scored from 0 to 4, with 4 representing the most severe response. Item responses are summed to give a score from 0-100, with higher score representing the worse possible
次要结局
- EQ5D-3L(2 years)
研究者
per hviid gundtoft
Principal Investigator, Senior House Officer, PhD
Sygehus Lillebaelt