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

Deformity, Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04039308
• Other study ID #: Deformity in Charcot foot
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: September 2020

Study information

• Verified date: August 2019
• Source: Assiut University
• Contact: Kerolos Maged, MBBCH
• Phone: +201063692926
• Email: Kerolosmaged230[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: September 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy, Neurogenic
• Congenital Abnormalities
• Deformity, Foot
• Foot Deformities
• Joint Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kerolos Maged

References & Publications (18)

1-World Health Organzation, Global report on diabetes .Geneva 2016

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.

8-Eichenholtz SN. Charcot Joints. Springfield, IL, USA: Charles C. Thomas; 1966.

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

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.

Clinics in podiatric medicine and surgery, ISSN: 1558-2302, Vol: 34, Issue: 2, Page: 275-280 .2017

El-Mowafi H, Abulsaad M, Kandil Y, El-Hawary A, Ali S. Hybrid Fixation for Ankle Fusion in Diabetic Charcot Arthropathy. Foot Ankle Int. 2018 Jan;39(1):93-98. doi: 10.1177/1071100717735074. Epub 2017 Oct 16. — View Citation

Gentili A, Masih S, Yao L, Seeger LL. Pictorial review: foot axes and angles. Br J Radiol. 1996 Oct;69(826):968-74. Review. — View Citation

Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. — View Citation

Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care. 2003 May;26(5):1435-8. — View Citation

Lowery NJ, Woods JB, Armstrong DG, Wukich DK. Surgical management of Charcot neuroarthropathy of the foot and ankle: a systematic review. Foot Ankle Int. 2012 Feb;33(2):113-21. doi: 10.3113/FAI.2012.0113. Review. — View Citation

Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. Review. — View Citation

Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. doi: 10.1007/s00125-008-0940-0. Epub 2008 Feb 23. — View Citation

Robinson AH, Pasapula C, Brodsky JW. Surgical aspects of the diabetic foot. J Bone Joint Surg Br. 2009 Jan;91(1):1-7. doi: 10.1302/0301-620X.91B1.21196. Review. — View Citation

Rogers LC, Frykberg RG, Armstrong DG, Boulton AJ, Edmonds M, Van GH, Hartemann A, Game F, Jeffcoate W, Jirkovska A, Jude E, Morbach S, Morrison WB, Pinzur M, Pitocco D, Sanders L, Wukich DK, Uccioli L. The Charcot foot in diabetes. Diabetes Care. 2011 Sep;34(9):2123-9. doi: 10.2337/dc11-0844. — View Citation

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

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of postoperative deformity correction in at least one- year postoperative follow up1x rays.	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.	3 years