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Procedure

Fixation vs. Removal for Broken Bones (FIRM Trial)

N/A
Recruiting
Led By Paul J Duffy, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has Lisfranc injury that was treated within 28 days of injury
The patient must be medically fit for anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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).

Who is the study for?
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.Check my eligibility
What is being tested?
The study compares two approaches after initial surgical treatment of Lisfranc injuries: keeping the hardware in place (HR) versus removing it (RH). It's a multicenter trial where participants will be randomly assigned to one of these two options.See study design
What are the potential side effects?
Potential side effects may include pain at the hardware site, infection risks associated with additional surgery for removal, possible re-injury or instability if hardware is removed, and general anesthesia risks during hardware removal.

FIRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I received treatment for a Lisfranc injury within 28 days of getting hurt.
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I am healthy enough to undergo anesthesia.
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My foot has a confirmed unstable lisfranc complex.
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My foot injury was properly aligned to within 1mm at the time of treatment.

FIRM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
SF-36
VAS - Visual Analogue Scale (Patient Satisfaction)
+1 more
Secondary outcome measures
Cost-effectiveness
Radiologic outcome

FIRM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hardware RemovalExperimental Treatment1 Intervention
Removal of hardware at 6 months.
Group II: Hardware RetentionActive Control1 Intervention
Retention of hardware at 6 months

Find a Location

Who is running the clinical trial?

Memorial University of NewfoundlandOTHER
67 Previous Clinical Trials
1,830,804 Total Patients Enrolled
University of CalgaryLead Sponsor
782 Previous Clinical Trials
845,795 Total Patients Enrolled
Calgary Orthopaedic Research and Education FundOTHER
3 Previous Clinical Trials
436 Total Patients Enrolled

Media Library

Hardware removal (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02374944 — N/A
Tarsometatarsal Joint Dislocation/Fracture Research Study Groups: Hardware Retention, Hardware Removal
Tarsometatarsal Joint Dislocation/Fracture Clinical Trial 2023: Hardware removal Highlights & Side Effects. Trial Name: NCT02374944 — N/A
Hardware removal (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02374944 — N/A

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI
~9 spots leftby Dec 2024