跳至主要内容
临床试验/NCT05039957
NCT05039957Unknown不适用

Management of Fracture Ankle in Patients With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation: Randomized Control Study

Assiut University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
Complication rate

研究概览

简要总结

Diabetes is a well-known risk factor for complications following ankle fracture fixation.Current recommendations for operative treatment of ankle fractures in patients with diabetes consist of increased rigid fixation and prolonged periods of non-weight bearing with minimally invasive techniques.

Yee et al described a treatment algorithm for ankle fractures in diabetes patients based on the extent of their diabetic complications, Adelaide Fracture in the Diabetic Ankle (AFDA) score, and suggest that primary ankle arthrodesis may be an option in severe situations.

Ebaugh et.al. described the technique of fixing the ankle joint in diabetic patients without joint preparation .

Primary hindfoot arthrodesis with Calcaneotibial nail with formal joint preparation was described by many authors as treatment for ankle fractures in diabetic patient .

To our knowledge, there is no comparative study in management of ankle fractures in diabetic patients using these two different techniques.

Our hypothesis is to try to prove that management of diabetic fracture ankle by hindfoot nail without joint preparation is better than other techniques regarding overall lower complication rate, higher functional outcome and better option for treatment of these patients using minimal invasive approaches in those high risk patients.

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 (Participant)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • All subjects aged 50y or more with recent fracture ankle (less than two weeks) with uncontrolled diabetes in form of high level of hemoglobinA1C ( >6.4% ) and/ or high random blood sugar level on admission (>200mg/dl). Patients with one or more complications due to diabetic e,g. neuropathy, nephropathy , and/or peripheral vascular disease.

排除标准

  • • Previous ankle fracture fixation in the same side.
  • Charcot arthropathy
  • Polytrauma, multiple skeletal injury.

结局指标

主要结局

Complication rate

时间窗: 6 months

wound infection, hardware failure, Charcot arthropathy, development of ulcer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

momen ayman fekry

Dr

Assiut University

研究点 (2)

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