What side effects are associated with this type of intervention?

Common treatments for ankle fractures include fibular intramedullary fixation (IMFN) and open reduction and internal fixation (ORIF). IMFN involves stabilizing the fibula by inserting a rod into the medullary cavity. Known side effects of IMFN can include infection, hardware irritation, and potential for nonunion or delayed union of the fracture. ORIF, which involves surgically aligning the bone fragments and securing them with plates and screws, shares similar risks such as infection, hardware-related complications, and issues with bone healing. Both methods aim to support bone healing and reduce complications, but careful monitoring for these side effects is essential.

What prior FDA approvals exist?

The FDA has approved various treatments for ankle fractures, including the use of intramedullary fixation devices. These devices, such as intramedullary rods, are designed to stabilize the fibula by being inserted into the medullary cavity, which supports bone healing and reduces complications. While specific FDA approvals for fibular intramedullary fixation (IMFN) in diabetic patients are not detailed, the general use of intramedullary implants for fibular fractures has been supported by clinical data, indicating their safety and potential effectiveness.

What other types of research exist?

Promising novel alternatives to Fibular Intramedullary Fixation (IMFN) for ankle fracture patients include: 1) Open Reduction and Internal Fixation (ORIF), which remains a standard treatment and has been supported by good data in high-risk populations. 2) Minimally invasive surgical techniques that reduce soft tissue damage and promote faster recovery. 3) Biodegradable implants that provide temporary support and gradually dissolve, reducing the need for a second surgery. 4) Advanced external fixation devices that offer stable support while allowing for early mobilization. These alternatives should be discussed with an orthopedic specialist to determine the best individualized treatment plan.

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Procedure

Fibular Nail vs. Standard Fixation for Ankle Fracture

N/A

Recruiting

Led By Kelly Hynes, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Unstable ankle fracture

Must not have

Fractures that the treating surgeon indicates requires a posterior approach to achieve stability

Any previous ligament or fracture surgery on the index ankle

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-operatively

Awards & highlights

Summary

This trial is investigating whether or not fibular intramedullary fixation impacts complication rates in comparison to the standard of care treatment for broken bones which is open reduction and internal fixation. There is good evidence to support both methods, but they have never been compared to each other. The knowledge gained from this trial has the potential to influence and adapt protocols to better treat this patient population.

Who is the study for?

This trial is for diabetic adults over 18 with unstable ankle fractures and specific blood sugar levels (HbA1c > 6.5, fasting BG > 120, non-fasting BG > 200). It excludes those with open fractures, previous ankle surgeries, immune deficiencies like HIV or hepatitis, multiple injuries that affect mobility, active infections at the fracture site, or who can't follow the study protocol.Check my eligibility

What is being tested?

The study compares two treatments for ankle fractures in diabetics: fibular intramedullary nail (IMFN) and standard open reduction and internal fixation (ORIF). The goal is to see if there's a difference in complication rates between these methods. This has not been studied before in diabetic patients.See study design

What are the potential side effects?

Potential side effects may include complications related to surgery such as infection risk at the surgical site, pain around the area of operation, possible damage to nearby nerves or blood vessels during surgery, and general risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a recent, unstable fracture in my ankle.

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I have diabetes with high blood sugar or HbA1c levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My surgeon recommends a specific surgery from the back to stabilize my fracture.

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I have had surgery on my ankle for a ligament issue or fracture.

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I have a broken bone that is exposed through my skin.

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I have multiple injuries on my limbs that affect my ability to move.

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I have an active infection or wound on my ankle.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite complication rate

Secondary outcome measures

Patient reported outcome scores

Trial Design

2Treatment groups

Active Control

Group I: Fibular intramedullary nailActive Control1 Intervention

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

Group II: Open reduction and internal fixation (ORIF)Active Control1 Intervention

Randomized in the OR to ankle fracture repair with ORIF

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ankle fractures include fibular intramedullary fixation (IMFN) and open reduction and internal fixation (ORIF). IMFN stabilizes the fibula by inserting a rod into the medullary cavity, which supports bone healing and reduces complications, particularly in high-risk patients like diabetics. ORIF involves surgically exposing the fracture site to realign the bones and securing them with plates and screws. Both methods aim to stabilize the fracture, ensure proper alignment, and facilitate healing, but IMFN may offer advantages in terms of reduced surgical trauma and potentially lower complication rates. Understanding these mechanisms is crucial for patients to make informed decisions about their treatment options.