Clinical trial NCT05204485: Diabetic Fibular Nail Study
Official title: Prospective, Randomized-Control Trial Comparing Intramedullary Fibular Fixation With Standard Open Reduction And Internal Fixation In Diabetic Patients With Unstable Ankle Fracture
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite complication rate
timeFrame: 1 year post-operatively
Secondary outcomes:
measure: Patient reported outcome scores
timeFrame: 1 year post-operatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Kelly Hynes, MD
role: PRINCIPAL_INVESTIGATOR
References: