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

NCT ID: NCT05039957

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Figure Out the Best Method of Fixation for Management of Patients With Diabetic Fracture Ankle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Group Type ACTIVE_COMPARATOR

joint preparation

Intervention Type OTHER

fixation of fracture with joint preparation

B

Group Type EXPERIMENTAL

without joint preparation

Intervention Type OTHER

fixation of fracture without joint preparation

Interventions

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joint preparation

fixation of fracture with joint preparation

Intervention Type OTHER

without joint preparation

fixation of fracture without joint preparation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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momen ayman fekry

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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momen Ayman Fekry, MD

Role: CONTACT

+201119196610

Facility Contacts

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momen ayman, MD

Role: primary

01119196610

Other Identifiers

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17200615

Identifier Type: -

Identifier Source: org_study_id

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