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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
Sponsor:
Information provided by (Responsible Party):
Kerolos Maged, Assiut University

Brief Summary:
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).

Condition or disease
Deformity, Foot

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with deforming Charcot neuroarthropathy of the foot and ankle
Criteria

Inclusion Criteria:

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

Patients received surgical management.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039308


Contacts
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Contact: Kerolos Maged, MBBCH +201063692926 Kerolosmaged230@gmail.com
Contact: Ahmed Othman, MD +20102756356 ah_911@yahoo.com

Sponsors and Collaborators
Kerolos Maged

Publications of Results:
Other Publications:
1-World Health Organzation, Global report on diabetes .Geneva 2016
8-Eichenholtz SN. Charcot Joints. Springfield, IL, USA: Charles C. Thomas; 1966.
Brodsky JW. Management of Charcot joints of the foot and ankle in diabetes. Semin Arthroplasty. 1992; 3: 58-62.
Brodsky JW. Patterns of breakdown in the Charcot tarsus of diabetics and relation to treatment. Foot and Ankle 1986;5:353.
Anthony S., Pomeroy G. (2016) Exostectomy for Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
Tan E.W., Schon L.C. (2016) Plate Fixation Techniques for Midfoot and Forefoot Charcot Arthropathy. In: Herscovici, Jr. D. (eds) The Surgical Management of the Diabetic Foot and Ankle. Springer, Cham
Use of External Fixation for the Management of the Diabetic Foot and AnkleDO - 10.1007/978-3-319-27623-6_13 - The Surgical Management of the Diabetic Foot and Ankle
Clinics in podiatric medicine and surgery, ISSN: 1558-2302, Vol: 34, Issue: 2, Page: 275-280 .2017
18-Abetz L, Sutton M, Brady L, McNulty P, Gagnon DD. The diabetic foot ulcer scale (DFS): a quality of life instrument for use in clinical trials. Prac Diabetes Int. 2002;19:167‐175.

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Responsible Party: Kerolos Maged, Resident of Orthopedics and traumatology, Assiut University
ClinicalTrials.gov Identifier: NCT04039308    
Other Study ID Numbers: Deformity in Charcot foot
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Joint Diseases
Arthropathy, Neurogenic
Foot Deformities
Congenital Abnormalities
Musculoskeletal Diseases