Hindfoot Fusion Using Intramedullary Nail in Diabetic Ankle Arthropathy

February 5, 2023 updated by: Ehab Ahmed Mohamed

Results of Hindfoot Fusion Using Modified Retrograde Intramedullary Femoral Nail With Plate in Diabetic Charcot Ankle Arthropathy : A Prospective Case Series Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients admitted at our trauma center at Assuit university hospital meeting the above mentioned criteria

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological fusion
Time Frame: to be assessed up to one year post operative
fusion of the Charcot ankle assessed by X- ray
to be assessed up to one year post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ehab Ahmed Mohamed

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2023

Primary Completion (ANTICIPATED)

February 1, 2024

Study Completion (ANTICIPATED)

February 1, 2024

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

February 5, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 5, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFFIMN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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