Fixation vs. Removal for Broken Bones
(FIRM Trial)
Trial Summary
What is the purpose of this trial?
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Hardware removal, Hardware removal surgery, Implant removal?
Is hardware removal surgery generally safe for humans?
Hardware removal surgery is generally considered safe, but it can carry risks of complications, especially in patients with certain conditions like liver disease or specific types of fractures. Studies show that while it is a common procedure, attention to potential complications is important, and outcomes are generally positive, especially in children.25678
How does hardware removal treatment differ from other treatments for broken bones?
Hardware removal is unique because it involves surgically taking out metal implants used to fix broken bones, especially when they cause pain or complications after healing. Unlike other treatments that focus on stabilizing the bone, this procedure addresses issues related to the implants themselves, such as discomfort or infection.12349
Research Team
Paul J Duffy, MD
Principal Investigator
University of Calgary
Eligibility Criteria
This trial is for individuals who have had a Lisfranc injury (midfoot dislocation/fracture) treated within the past 28 days and are between 6 to 8 weeks post-initial fixation surgery. They must be medically fit, able to follow the study protocol, and not have significant pre-existing foot conditions or injuries that could affect recovery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either hardware removal or retention after open reduction and internal fixation of Lisfranc injuries
Follow-up
Participants are monitored for safety and effectiveness after treatment with assessments at multiple time points
Treatment Details
Interventions
- Hardware removal
Hardware removal is already approved in United States, European Union for the following indications:
- Pain from hardware
- Infection
- Allergic reaction to hardware
- Nerve damage
- Broken hardware
- Bones that did not heal and join properly
- Pain from hardware
- Infection
- Allergic reaction to hardware
- Nerve damage
- Broken hardware
- Bones that did not heal and join properly
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Memorial University of Newfoundland
Collaborator
Calgary Orthopaedic Research and Education Fund
Collaborator