Hindfoot Fusion Using Intramedullary Nail in Diabetic Ankle Arthropathy

NCT ID: NCT05717816

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2024-02-29

Brief Summary

The aim of this study is to evaluate the outcome of healing rate of ankle fusion using modified retrograde IM femoral nail with plate in charcot ankle

Detailed Description

Charcot neuroarthropathy, is a progressive, noninfectious, and destructive joint disorder following trauma to a neuropathic extremity.The disorder mainly occurs in the foot and ankle joints. The process consists of bone and joint destruction, joint deformity, ulceration, and, if left untreated, may lead to amputation. The majority of the Charcot joint cases are associated with a neuropathic complication in patients with diabetes. Thus, with the increase in the current incidence of diabetes, the increase of Charcot joint cases is also expected.

The treatment of Charcot joint is variable including non operative, such as total contact casting, modified shoe, medication, and operative treatment. However, when the deformity is severe and unstable, the operative management is necessary. There are some surgical approaches to manage Charcot joint, such as exostectomy, Achilles tendon lengthening, arthrodesis with internal or external fixation, and amputation.

Arthrodesis is indicated in severe Charcot joint with significant instability. For Charcot ankle arthrodesis, internal fixation is more popular than external fixation in the absence of infection, significant bone defect, and poor soft tissue coverage. Some of the methods of internal fixation for ankle arthrodesis include the use of retrograde intramedullary nails, screws, and plates. many surgeons chose retrograde intramedullary nail fixation as the main method of internal fixation. However, limited compression and high nonunion rates have been found with intramedullary nail fixation.so using Plate with intramedullary nail will offer stiff constructs, more stability and better union rates. however, studies evaluating the use of combination fixation in the ankle arthrodesis for Charcot ankle, particularly nail with plate, are limited. [13] So, in this study the investigators will evaluate the outcomes of ankle arthrodesis using a combination of an intramedullary nail with plate in patients with diabetic Charcot ankle.

Conditions

Charcot Arthropathy of Hindfoot

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

intramedullary nail and plate

fusing Charcot ankle using retrograde intrameudllary femoral nail and plate

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult diabetic Patients who have (Brodsky type 2 and type 3A) Charcot ankle and HbA1c below 8

Exclusion Criteria

• Prescence of active infection
• prescence of ulcers
• significant bone defect
• Vascular insufficiency

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ehab Ahmed Mohamed

OTHER

Sponsor Role: lead

Responsible Party

Ehab Ahmed Mohamed

Participant investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

HFFIMN

Identifier Type: -

Identifier Source: org_study_id