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Fixation vs. Removal for Broken Bones (FIRM Trial)
FIRM Trial Summary
This trial is comparing two ways of treating people who have had surgery to fix a broken bone in their leg. The first group will have metal rods and screws put in to hold the bone in place (hardware retention). The second group will have the metal rods and screws taken out after the bone has healed (removal of hardware).
FIRM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFIRM Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FIRM Trial Design
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Who is running the clinical trial?
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- I am at high risk for surgery complications due to my health.My previous treatment for bone repair has failed before joining.I have had surgery to correct a foot problem.I have had a fracture due to my cancer.I received treatment for a Lisfranc injury within 28 days of getting hurt.My previous treatment to stabilize a bone or joint didn't hold up.My foot has a confirmed unstable lisfranc complex.I joined the study 6 to 8 weeks after my initial surgery.I am healthy enough to undergo anesthesia.I have a serious foot injury.I have an infection needing surgery in the area where another surgery is planned.I have a condition like rheumatoid arthritis or diabetes that affects my foot's bone structure.I have another injury that may slow down my recovery.I have an injury to the bones or ligaments in my foot.I am willing and able to sign the consent form for the trial.My foot injury was properly aligned to within 1mm at the time of treatment.I have a fracture in my heel bone, ankle bone, or the top of my shinbone.
- Group 1: Hardware Retention
- Group 2: Hardware Removal
- 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
What is the scale of enrolment for this trial?
"Affirmative. Clinicaltrials.gov has the latest information regarding this medical evaluation, which was first posted on January 23rd 2018 and updated as recently as November 4th 2022. 94 individuals are being recruited from one site to participate in this study."
Does this trial have open enrollment at present?
"Per the information published on clinicaltrials.gov, this medical investigation is actively looking for eligible participants. The trial was initially posted in January of 2018 and has been renewed as recently as November 4th 2022."
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