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Fibular Nail vs. Standard Fixation for Ankle Fracture
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I have a recent, unstable fracture in my ankle.My surgeon recommends a specific surgery from the back to stabilize my fracture.I have had surgery on my ankle for a ligament issue or fracture.I have a broken bone that is exposed through my skin.My fracture was diagnosed more than 4 weeks after it happened.I have multiple injuries on my limbs that affect my ability to move.I have diabetes with high blood sugar or HbA1c levels.I have an inflammatory or other rheumatic disease.I have an active infection or wound on my ankle.
- Group 1: Fibular intramedullary nail
- Group 2: Open reduction and internal fixation (ORIF)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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