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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05039957
Enrollment
36
Registered
2021-09-10
Start date
2021-09-30
Completion date
2024-06-30
Last updated
2021-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERjoint preparation

fixation of fracture with joint preparation

OTHERwithout joint preparation

fixation of fracture without joint preparation

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complication rate6 monthswound infection, hardware failure, Charcot arthropathy, development of ulcer

Countries

Egypt

Contacts

Primary Contactmomen Ayman Fekry, MD
m.ayman112@live.com+201119196610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026