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

Study Overview
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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.

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

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

Intervention / Treatment
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* Other: joint preparation
* Other: without joint preparation


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Other: joint preparation<br>* fixation of fracture with joint preparation<br>|
| Experimental: B<br> | Other: without joint preparation<br>* fixation of fracture without joint preparation<br>|

What is the study measuring?
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Primary Outcome Measures

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