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Implant Removal vs. Fixation for Lisfranc Injury (FIRM Trial)
N/A
Recruiting
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient must be medically fit for anesthesia
18 years of age or older and skeletally mature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
FIRM Trial Summary
This trial is looking at whether or not it's better to remove implants after surgery for a Lisfranc injury.
Who is the study for?
This trial is for adults over 18 who have had a Lisfranc injury to the midfoot treated with screws or plates within the past 21 days. Participants must be medically fit for anesthesia, able to follow the study protocol and attend all follow-ups. Exclusions include active infections, other injuries affecting recovery, high surgical risk (ASA Class V), cognitive impairments, pregnancy, previous foot deformities or conditions like rheumatoid arthritis.Check my eligibility
What is being tested?
The study aims to determine whether it's better to remove or keep implants used in fixing Lisfranc injuries of the midfoot after surgery. It will compare patient-reported outcomes and x-ray results between two groups: one undergoing implant removal and another retaining their implants.See study design
What are the potential side effects?
Potential side effects may include complications from additional surgery such as infection risks, pain at the site of implant removal, possible damage during surgery leading to functional impairment, and general risks associated with anesthesia.
FIRM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am healthy enough to undergo anesthesia.
Select...
I am 18 years old or older and my bones have stopped growing.
FIRM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Foot and Ankle Ability Measure (FAAM)
Secondary outcome measures
American Orthopedics Foot and Ankle Midfoot Score (AOFAS)
Comparative cost analysis between treatment groups
Patient-reported Visual Analogue Scale (VAS) for Foot and Ankle
+2 moreFIRM Trial Design
2Treatment groups
Active Control
Group I: Retention GroupActive Control1 Intervention
The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery.
Group II: Removal GroupActive Control1 Intervention
The implant removal group will have surgery scheduled 6 months after their initial surgical fixation.
Find a Location
Who is running the clinical trial?
Memorial University of NewfoundlandOTHER
67 Previous Clinical Trials
1,830,798 Total Patients Enrolled
University of CalgaryLead Sponsor
782 Previous Clinical Trials
845,789 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study rules and attend all appointments.I have an infection where I might have surgery.I joined the study 4 to 8 weeks after my initial surgery.I am at high risk for surgery complications.I have another injury that could slow down my recovery.I have a history of conditions like rheumatoid arthritis or diabetes affecting my foot.I had surgery with screws or plates for a Lisfranc injury within 3 weeks of the injury.I am healthy enough to undergo anesthesia.I have a serious foot injury or deformity.I had surgery to fuse joints in my foot.I am 18 years old or older and my bones have stopped growing.I am willing and able to sign a consent form for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Retention Group
- Group 2: Removal Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings in this clinical experiment?
"The information hosted on clinicaltrials.gov affirms that this research initiative is actively seeking volunteers; it was made public by September 7th 2017 and has been modified most recently on July 7th 2022."
Answered by AI
To what extent is participation in this trial being limited?
"Affirmative. Clinicaltrials.gov host the information that proves this clinical trial is still recruiting participants since its initial posting on September 7th 2017 and most recent update of July 7th 2022. The study requires 100 patients to be recruited from one site."
Answered by AI
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