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Fibular Nail vs. Standard Fixation for Ankle Fracture

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
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-operatively
Awards & highlights

Study 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
I am 18 years old or older.
I have a recent, unstable fracture in my ankle.
I have diabetes with high blood sugar or HbA1c levels.


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

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,003 Previous Clinical Trials
819,629 Total Patients Enrolled
Kelly Hynes, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Fibular intramedullary nail (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05204485 — N/A
Ankle Fracture Research Study Groups: Fibular intramedullary nail, Open reduction and internal fixation (ORIF)
Ankle Fracture Clinical Trial 2023: Fibular intramedullary nail Highlights & Side Effects. Trial Name: NCT05204485 — N/A
Fibular intramedullary nail (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05204485 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can elderly individuals participate in this research project?

"Participants must be between 18-85 years old to be included in this trial, with 3 separate clinical trials for people outside of this age bracket."

Answered by AI

Are researchers still working to include more participants in this experiment?

"The trial, which was originally posted on March 7th, 2022, is still searching for participants, as of May 16th, 2022."

Answered by AI

Are there any prerequisites to qualify for this research?

"The investigators conducting this study are looking for 120 individuals that have recently suffered an ankle fracture. These patients must be between 18-85 years old, have an unstable ankle fracture, and have a Fasting BG > 120 and a Non-fasting BG > 200. In addition, their HbA1c must be > 6.5."

Answered by AI
~44 spots leftby Aug 2025