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

Not Applicable

• Conditions: Figure Out the Best Method of Fixation for Management of Patients With Diabetic Fracture Ankle
• Interventions: Other: joint preparation; Other: without joint preparation

• Registration Number: NCT05039957
• Lead Sponsor: Assiut University

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-02
• Last Update Submitted: 2021-09-02
• Study First Posted: 2021-09-10
• Last Update Posted: 2021-09-10
• Study Start: 2021-09-30
• Primary Completion: 2022-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	joint preparation	-
B	without joint preparation	-

Primary Outcome Measures

Name	Time	Method
Complication rate	6 months	wound infection, hardware failure, Charcot arthropathy, development of ulcer

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt