Diabetic Fibular Nail Study

Ankle Fractures Clinical Trial

Official title:

Prospective, Randomized-Control Trial Comparing Intramedullary Fibular Fixation With Standard Open Reduction And Internal Fixation In Diabetic Patients With Unstable Ankle Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05204485
• Other study ID #: IRB21-1218
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: August 7, 2025

Study information

• Verified date: May 2022
• Source: University of Chicago
• Contact: Justin Bell
• Phone: 773-834-0822
• Email: jbell3[@]bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 7, 2025
• Est. primary completion date: August 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Fractures

Intervention

Procedure:
• Fibular intramedullary nail
The standard manufacturers approved technique will be performed including the use of 2 distal interlocking screws and the use of a minimum of 1 fibula pro tibia fixation screw depending on the patients' anatomical characteristics.
• Open reduction and internal fixation
An open approach (direct lateral or posterolateral incision) will be carried out. The reduction will be performed using standard techniques of clamping and traction. Fixation will be performed after reduction of the fracture with a plate and screw construct. The surgeon will then proceed to perform surgical fixation of other associated fractures or ligament injuries as indicated. This will most often include open reduction and internal fixation of the medial malleolus with screws through a separate medial incision.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite complication rate	The difference in overall composite complication rate between Fibular intramedullary fixation and ORIF	1 year post-operatively
Secondary	Patient reported outcome scores	Any difference in Patient reported outcomes scores (PROMIS Physical Function or Pain Interference CAT) score between Fibular Intramedullary fixation and ORIF	1 year post-operatively