Implant Removal vs. Fixation for Lisfranc Injury

(FIRM Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial compares keeping versus removing surgical implants in patients with Lisfranc injuries. It aims to find out which approach leads to better recovery by measuring pain, foot function, and overall outcomes.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to follow the study rules and attend all appointments.

I joined the study 4 to 8 weeks after my initial surgery.

I had surgery with screws or plates for a Lisfranc injury within 3 weeks of the injury.

Exclusion Criteria

Delay in initial treatment greater than 21 days from time of injury

I have an infection where I might have surgery.

Likely unable to maintain follow-up

Treatment Details

Interventions

• Implant removal (Procedure)

Trial Overview 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.

Participant Groups

Group I: Removal Group Active Control 1 Intervention

The implant removal group will have surgery scheduled 6 months after their initial surgical fixation.

Group II: Retention Group Active Control 1 Intervention

The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Dr. Shweta Patel

University of Calgary

Chief Medical Officer since 2020

MD from the University of Baroda Medical College, India

Dr. Edward McCauley

University of Calgary

President and Vice-Chancellor since 2018

PhD in Ecology and Evolutionary Biology from the University of California, Santa Barbara

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

Dr. Jennifer Lokash

Memorial University of Newfoundland

Chief Executive Officer

PhD in English Literature

Dr. Ken Fowler

Memorial University of Newfoundland

Chief Medical Officer since 2023

MD