Management of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital

September 2, 2021 updated by: momen ayman fekry, Assiut University

Management of Fracture Ankle in Patients With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation: Randomized Control Study

Diabetes is a well-known risk factor for complications following ankle fracture fixation.Current recommendations for operative treatment of ankle fractures in patients with diabetes consist of increased rigid fixation and prolonged periods of non-weight bearing with minimally invasive techniques.

Yee et al described a treatment algorithm for ankle fractures in diabetes patients based on the extent of their diabetic complications, Adelaide Fracture in the Diabetic Ankle (AFDA) score, and suggest that primary ankle arthrodesis may be an option in severe situations.

Ebaugh et.al. described the technique of fixing the ankle joint in diabetic patients without joint preparation .

Primary hindfoot arthrodesis with Calcaneotibial nail with formal joint preparation was described by many authors as treatment for ankle fractures in diabetic patient .

To our knowledge, there is no comparative study in management of ankle fractures in diabetic patients using these two different techniques.

Our hypothesis is to try to prove that management of diabetic fracture ankle by hindfoot nail without joint preparation is better than other techniques regarding overall lower complication rate, higher functional outcome and better option for treatment of these patients using minimal invasive approaches in those high risk patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Assiut University Hospital
        • Contact:

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

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • All subjects aged 50y or more with recent fracture ankle (less than two weeks) with uncontrolled diabetes in form of high level of hemoglobinA1C ( >6.4% ) and/ or high random blood sugar level on admission (>200mg/dl). Patients with one or more complications due to diabetic e,g. neuropathy, nephropathy , and/or peripheral vascular disease.

Exclusion Criteria:

  • • Previous ankle fracture fixation in the same side.

    • Charcot arthropathy
    • Polytrauma, multiple skeletal injury.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Other: joint preparation
fixation of fracture with joint preparation
Experimental: B
Other: without joint preparation
fixation of fracture without joint preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 6 months
wound infection, hardware failure, Charcot arthropathy, development of ulcer
6 months

Collaborators and Investigators

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

Sponsor

Assiut University

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)

September 30, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200615

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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