Status:
TERMINATED
Diabetic Fibular Nail Study
Lead Sponsor:
University of Chicago
Conditions:
Ankle Fractures
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). Ther...
Detailed Description
Our null hypothesis is that fibular intramedullary fixation (IMFN) does not impact complication rates when compared to standard of care treatment with open reduction and internal fixation (ORIF). Ther...
Eligibility Criteria
Inclusion
- Age 18 or older
- Unstable ankle fracture
- Diagnosis of Diabetes:
- Fasting BG \> 120
- Non-fasting BG \> 200
- HbA1c \> 6.5
Exclusion
- Patients not meeting inclusion criteria (stable fracture patterns, non-diabetics)
- Poly-trauma patients (multiple \[\>2\] extremity injuries that interfere and/or limit patient mobilization
- Open fractures
- Delayed presentation of fracture (\>4 weeks)
- Fractures that the treating surgeon indicates requires a posterior approach to achieve stability
- Patients with an active infection or wound at the ankle
- Utilizing worker's compensation at the time of screening
- Any previous ligament or fracture surgery on the index ankle
- Inflammatory rheumatic disease or other rheumatic disease
- Immune compromised patients (hepatitis, HIV, etc.)
- Non-English speaking patients
- Unwilling or unable to follow study protocol
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05204485
Start Date
March 7 2022
End Date
January 19 2024
Last Update
October 16 2024
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637