Diabetic Fibular Nail Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ankle Fractures
• Intervention / Treatment: Procedure: Fibular intramedullary nail; Procedure: Open reduction and internal fixation

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Hynes, MD; Phone Number: 773-834-3531; Email: khynes@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Justin Bell, BA; Phone Number: 773-834-0822; Email: jbell3@bsd.uchicago.edu
      • Principal Investigator: Kelly Hynes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fibular intramedullary nail; Randomized in the OR to ankle fracture repair with fibular intramedullary nail	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.
Active Comparator: Open reduction and internal fixation (ORIF); Randomized in the OR to ankle fracture repair with ORIF	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite complication rate	The difference in overall composite complication rate between Fibular intramedullary fixation and ORIF	1 year post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Kelly Hynes, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Anticipated): August 7, 2025
• Study Completion (Anticipated): August 7, 2025

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Ankle Fractures
• Other Study ID Numbers: IRB21-1218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No