Comparison Between Outpatient and Inpatient Surgically Treated Ankle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Foot and Ankle Outcomes Score
研究概览
简要总结
This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.
详细描述
This study is a single center randomized controlled trail in which we compare outpatient and inpatient patients with an ankle fracture requiring surgical treatment.
Primary outcome: The primary objective of this study is to compare the 12-weeks patient reported Foot and Ankle Outcome Score (FOAS).
Secondary outcomes: Multiple other analysis are planned, but being secondary, they are hypothesis generating. They will include, but are not limited to, cross-over, unscheduled contacts, adverse events, pain, general health, time to return to work and socio-economic consequences between the two groups.
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 (Outcomes Assessor)
盲法说明
Due to the nature of this study the patient, surgeon and care providers can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.
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
- •Ankle fracture indicating surgical treatment.
- •Fracture stable in lower leg cast.
- •Patient 18 years or older.
- •Patient is able to ambulate with walking aid, and perform ADL at home.
排除标准
- •Impaired physical, mental or social capacity incapable of participating in study.
- •Incapable of reading or understanding Danish.
- •Patient does not wich to participate.
- •Concurrent major fracture to lower extremity (ipsi- and/or contralateral)
- •Patholocigal fracture
- •ASA score 3 or higher.
- •Pregnancy.
- •Open fracture.
- •Infectious disease requiring isolation.
结局指标
主要结局
Foot and Ankle Outcomes Score
时间窗: 12 weeks
The FAOS is a patient-reported structure-specific questionnaire. Consisting of 5 subscales: pain, symptoms, activities of daily living (ADL), function in sport and recreation (Sport/Rec), and foot- and ankle-related quality of life (QOL). A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The result can be plotted as an outcome profile.
次要结局
- Ankle range of motion(6 and 12 weeks)
- Time to return to work(2, 6 and 12 weeks)
- Patient satisfaction(2, 6 and 12 weeks)
- Tegner activity scale(12 weeks)
- Bone union(6 and 12 weeks)
- Adverse events(2 days, 2, 6 and 12 weeks)
- Pain intensity measured on a 10 cm VAS scale(2 days, 2, 6 and 12 weeks)
- EQ-5D-5L questionnaire (5-level version)(2, 6 and 12 weeks)
研究者
Christian Grundtvig Refstrup Rasmussen
Principle investigator
Aalborg University Hospital