NCT00556010已完成不适用
Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Ankle fractures are common injuries that are being operated routinely. In order to restore the long term function and prevent arthritis of the ankle the broken fragments should be put in place precisely. Inadequate reduction can result in pain and long term disability. Recently, based on MRI studies and clinical studies, a significant number of ankle fractures are apparently fixed with less than optimal results. We suggest that the use of a new device that enables better three dimensional imaging will improve the quality of operations performed for ankle fractures.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unstable ankle fractures (as classified by the AO as 44B 44C by Lauge Hansen PER4 or SER4) amenable to open reduction and internal fixation.
- •Patients with syndesmotic rupture as evident from the injury films or during clinical testing in the OR be included in the study.
- •Intraoperative testing will include both a cotton Test and a stress view obtained after bimalleolar fixation has been attained.
- •A positive syndesmotic injury will be defined by the criteria of Pettrone et al as follows: a tib/fib clear space >5mm or tib/fib overlap of <10mm (on the AP view), or a tib/fib overlap of <1mm on the mortise view.
排除标准
- •Patients with a pilon fracture (i.e. plafond fractures AO type 43B and C) will be excluded even if associated with a fibula fracture and syndesmosis disruption.
- •Patients with contraindications to operative treatment and diabetics
- •Women of childbearing age will be excluded if they present with a positive pre-op Beta HCG test or if they refuse a B HCG test.
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Comparison of the Results of Complex Ankle Fractures Treated With and Without Ankle ArthroscopyAnkle FracturesNCT02449096Ludwig-Maximilians - University of Munich80
进行中（未招募）
不适用
Transitional Ankle Fracture Management Using a New Joystick TechniqueTibial FractureNCT05012449The Fuzhou No 2 Hospital30
Unknown
不适用
AORIF Complex Ankle FracturesAnkle FracturesNCT04033848Ludwig-Maximilians - University of Munich100
进行中（未招募）
Unknown
Ankle fracture imaging of patients with a complex injuryComplex and/or unstable ankle fractureInjury, Occupational Diseases, PoisoningISRCTN25963775Mid Yorkshire Hospitals NHS Trust60
招募中
不适用
3D guided surgery for intra-articular fractures of the tibiaNL-OMON49274niversitair Medisch Centrum Groningen50