Diabetic Fibular Nail Study

NCT05204485 | Terminated DMC

• 1 other identifier: IRB21-1218
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Fractures

Outcome Measures

Primary Outcomes (1)

• Composite complication rate

  The difference in overall composite complication rate between Fibular intramedullary fixation and ORIF

  1 year post-operatively

Secondary Outcomes (1)

• Patient reported outcome scores

  1 year post-operatively

Study Arms (2)

Fibular intramedullary nail

ACTIVE COMPARATOR

Randomized in the OR to ankle fracture repair with fibular intramedullary nail

Procedure: Fibular intramedullary nail

Open reduction and internal fixation (ORIF)

ACTIVE COMPARATOR

Randomized in the OR to ankle fracture repair with ORIF

Procedure: Open reduction and internal fixation

Interventions

Fibular intramedullary nail PROCEDURE

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.

Fibular intramedullary nail

Open reduction and internal fixation PROCEDURE

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.

Open reduction and internal fixation (ORIF)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Unstable ankle fracture
• Diagnosis of Diabetes:
• Fasting BG \> 120
• Non-fasting BG \> 200
• HbA1c \> 6.5

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Ankle Fractures

Interventions

Open Fracture Reduction; Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Kelly Hynes, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 24, 2022
• Study Start: March 7, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)