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临床试验/NCT04039308
NCT04039308Unknown不适用

Assessment of Surgical Correction of Deformity in Diabetic Charcot Arthropathy of the Foot and Ankle

Kerolos Maged0 个研究点目标入组 70 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
主要终点
Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays.

研究概览

简要总结

The surgical techniques described in the literature for surgical management of diabetic charcot arthropathy of the foot and ankle include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening. Patients are followed up at 1 year postoperative by an x-ray of the foot and ankle anteroposterior , lateral and oblique views to assess rate of union ,the correction of deformity by measuring the foot angles . The functional outcome is assessed by the AOFAS scoring system and the diabetic foot ulcer scaoeuulcer scale(18).

详细描述

Diabetes mellitus affected approximately 422 million people worldwide in 2016 . Diabetic complications including diabetic peripheral neuropathy and peripheral arterial disease remain prevalent in the USA and worldwide and challenging to treat. Due to loss of protective sensation and impaired vascular supply, these can lead to serious foot complications including deformity, diabetic foot ulceration, Charcot neuroarthropathy and infection .

Charcot neuroarthropathy is a devastating orthopedic condition that afflicts patients with diabetes. It is an inflammatory condition that affects the foot and ankle with varying degrees of bone destruction and deformity. The true incidence or prevalence of this condition is not known.

However, estimates demonstrate incidence to be between 0.1 and 0.9%

. Two principal pathways for the disease have been proposed. The neurotraumatic theory suggests that the loss of neuroprotection causes repetitive microtrauma. The opposing hypothesis, the neurovascular, is that sympathetic neuropathy results in hyperaemia. This leads to increased osteoclastic activity resulting in bone resorption and fragmentation.

The active form of charcot foot arthropahy is often misdiagnosed as tenosynovitis, cellulitis, or gout. The majority of these patients endure a short period of disability that is treated by some form of immobilization for a variable period of time with minimal resultant long-term disability. The diagnosis is not often clear until resolution of the swelling when a resultant residual deformity is appreciated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with inactive form of Charcot arthropathy of the foot and ankle due to diabetes mellitus.
  • Patients received surgical management.

排除标准

  • Active form of Charcot arthropathy of the foot and ankle. Non deforming Charcot arthropathy of the foot and ankle. Patients with heavy infection or vascular affection that necessitate amputation.

结局指标

主要结局

Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays.

时间窗: 3 years

Assessment of accuracy of correction in patients with Charcot neuroarthropathy of the foot and ankle using follow up x rays and measuring the foot and ankle angles. The normal angles are documented, so we will compare these angles with the normal ones.

次要结局

未报告次要终点

研究者

发起方
Kerolos Maged
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kerolos Maged

Resident of Orthopedics and traumatology

Assiut University

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