Back to resultsManagement of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital
Primary Purpose
Figure Out the Best Method of Fixation for Management of Patients With Diabetic Fracture Ankle
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
joint preparation
without joint preparation
Sponsored by
About this trial
This is an interventional treatment trial for Figure Out the Best Method of Fixation for Management of Patients With Diabetic Fracture Ankle
Eligibility Criteria
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.
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Complication rate
wound infection, hardware failure, Charcot arthropathy, development of ulcer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05039957
Brief Title
Management of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital
Official Title
Management of Fracture Ankle in Patients With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation: Randomized Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Figure Out the Best Method of Fixation for Management of Patients With Diabetic Fracture Ankle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
joint preparation
Intervention Description
fixation of fracture with joint preparation
Intervention Type
Other
Intervention Name(s)
without joint preparation
Intervention Description
fixation of fracture without joint preparation
Primary Outcome Measure Information:
Title
Complication rate
Description
wound infection, hardware failure, Charcot arthropathy, development of ulcer
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
momen Ayman Fekry, MD
Phone
+201119196610
Email
m.ayman112@live.com
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
momen ayman, MD
Phone
01119196610
Email
m.ayman112@live.com
12. IPD Sharing Statement
Learn more about this trial
Management of Fracture Ankle in Adults With Uncontrolled Diabetes by Hind Foot Nail With Versus Without Joint Preparation , in Assiut University Hospital
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