Arthroscopically Assisted Treatment of Complex Ankle Fractures - Intraarticular Findings and Prospective PROM Follow-Up
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- OMAS
研究概览
简要总结
The aim of this study is to evaluate the intraarticular lesions, to identify fractures specifically at risk for these, and to assess the results following arthroscopically assisted open reduction and internal fixation of complex ankle fractures prospectively.
详细描述
Starting 05/01/13 patients with complex ankle fractures, older than 17 years, who sustained the injury less than 14 days before surgery and giving informed consent are consecutively enrolled. A complex fracture is defined as either an isolated malleolar fracture in combination with ligamentous instability, or a bi- or trimalleolar fracture. An unstable ligamentous injury is defined as either a disruption of the deltoid ligament leading to increased medial talar tilt, or an unstable syndesmotic injury assessed by the external rotation test both after osteosynthesis of all fractures. Exclusion criteria are isolated unimalleolar fractures, pilon fractures, open fractures, multiple injuries, mental illness, incompliance or pregnancy.
Data assessed are:
- Demographics
- Medical history
- Classification (AO, Haraguchi, ICRS, location and size defect)
- Surgery details
- Complications
- PROMs (FAAM, AOFAS, OMAS, FAOS, TAS, SF-12, EQ-5d, MoxFQ)
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unimalleolar fracture + ligamentous injury
- •Bi- or trimalleolar fracture ± ligamentous injury
- •> 17 years
- •Date of injury less than 15 days
- •Written informed consent
排除标准
- •Isolated unimalleolar fracture
- •Pilon fracture
- •Open fracture
- •Mental illness, incompliance, pregnancy
- •Multiple injuries
结局指标
主要结局
OMAS
时间窗: Through study completion, an average of 1 year
Olerud and Molander Ankle Score; Validated PROM; Range 0-100
次要结局
- SF-12(Through study completion, an average of 1 year)
- ICRS: Clinical Cartilage Injury Evaluation System(IntraOP)
- TAS(Through study completion, an average of 1 year)
- EQ-5d(Through study completion, an average of 1 year)
- FAAM(Through study completion, an average of 1 year)
- AOFAS(Through study completion, an average of 1 year)
- MoxFQ(Through study completion, an average of 1 year)
- FAOS(Through study completion, an average of 1 year)
研究者
Sebastian. F. Baumbach
Principle Investigator
Ludwig-Maximilians - University of Munich