Implant Removal vs. Fixation for Lisfranc Injury

(FIRM Trial)

Overseen By Prism Schneider, MD,PhD,FRCS(C)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Rheumatoid arthritis, Diabetes, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Initial surgical fixation with screw and/or plate for Lisfranc injuries

Surgery

1 visit (in-person)

Implant Management

Comparison of implant retention versus scheduled implant removal

6 months

1 visit (in-person) for removal group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of functional outcomes and radiographic evaluations

24 months

Regular follow-up visits (in-person)

Treatment Details

Interventions

• Implant removal

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+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+