Diabetic Fibular Nail Study

Not Applicable

Terminated

• Conditions: Ankle Fractures
• Interventions: Procedure: Open reduction and internal fixation; Procedure: Fibular intramedullary nail

• Registration Number: NCT05204485
• Lead Sponsor: University of Chicago

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). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.

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). There are no current or past RCTs comparing these fixation techniques to one another in diabetic patients. There is good data supporting both the use of intramedullary fixation for fibular fractures alone, and in high-risk patient populations (elderly, and diabetics). However, the effectiveness of these methods with respect to each other has never been investigated. The knowledge gained will allow us to potentially influence and adapt protocols to treat this patient population. Additionally, resources available at our institution provide a supportive framework with which to maintain contact with patients after hospital discharge. These key factors will allow us to perform a robust analysis of this population, to include outcomes measures of function and complications.

With much of the existing literature on fibular nails being retrospective with limited focus on the diabetic population, there is no clear guidance on when the use of this device is indicated. Retrospective studies in fracture patients bring in significant bias given that a specific surgical technique may be chosen because of individual patient factors including soft tissue condition, fracture pattern and perceived level of risk. This limits our understanding of how an implant will perform across the population of interest. Our approach to randomize our patients will reduce the bias that exists in the current literature. In addition, the only prospective study that has been performed on the fibular nail was in elderly patients in which only two patients were diabetic. Given the many challenges with high rates of infection in this patient population we seek intramedullary fibular fracture fixation as a treatment that could potentially change this existing paradigm

Primary Objective Compare post-operative all cause complications in diabetic patients with ankle fractures.

Secondary Objective(s) Compare patient reported outcomes, range of motion, pain and radiographic outcomes in patients treated with ORIF vs. fibular intramedullary nails.

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-24
• Study Start: 2022-03-07
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Age 18 or older

• Unstable ankle fracture

• Diagnosis of Diabetes:

  • Fasting BG > 120
  • Non-fasting BG > 200
  • HbA1c > 6.5

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open reduction and internal fixation (ORIF)	Open reduction and internal fixation	Randomized in the OR to ankle fracture repair with ORIF
Fibular intramedullary nail	Fibular intramedullary nail	Randomized in the OR to ankle fracture repair with fibular intramedullary nail

Primary Outcome Measures

Name	Time	Method
Composite complication rate	1 year post-operatively	The difference in overall composite complication rate between Fibular intramedullary fixation and ORIF

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome scores	1 year post-operatively	Any difference in Patient reported outcomes scores (PROMIS Physical Function or Pain Interference CAT) score between Fibular Intramedullary fixation and ORIF

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States