Assessment of Surgical Correction of Deformity in Diabetic Charcot Arthropathy of the Foot and Ankle
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|ClinicalTrials.gov Identifier: NCT04039308|
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : August 30, 2019
|Condition or disease|
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.
Eichenholtz classification is used to define Charcot foot clinical stages. Brodsky the classification, in the other hand, allows us to locate the lesion anatomically.
The incidence of diabetic neuroarthropathy varies among the anatomical regions of the foot and ankle according to Brodsky classification. Approximately 70% of cases affect the tarsometatarsal joint (type 1). Type-1 disease is the least likely to require surgical stabilization, although the most common type to cause plantar ulceration. Type-2 disease involves the midtarsal and subtalar joints and accounts for approximately 20% of cases. Type-3 disease affects approximately 10% of patients, and occurs mainly in the ankle. Type 2 and type 3 are the most likely to progress to instability and often require long-term bracing or surgical reconstruction.
The surgical techniques described in the literature include simple exostectomy, open reduction and internal fixation of neuropathic fractures, external fixation, arthrodesis, Achilles tendon lengthening and, eventually, amputation.The goal of Charcot neuroarthropathy treatment, both orthopedic and surgical is to obtain an ulcer free, stable plantigrade foot, without osteomyelitis and able to ambulate. Achieving these goals notably reduces the rate of amputations.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Assessment of Surgical Correction of Deformity in Diabetic Charcot Arthropathy of the Foot and Ankle|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||September 2020|
- Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays. [ Time Frame: 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039308
|Contact: Kerolos Maged, MBBCH||+201063692926||Kerolosmaged230@gmail.com|
|Contact: Ahmed Othman, MDemail@example.com|