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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to treat Lisfranc injuries, which affect the joint in the middle of the foot and can be very painful and hard to heal. Researchers are comparing two options: removing the implant (screws or plates) after surgery or leaving it in place. The goal is to determine which option leads to better recovery and fewer complications. Individuals who have undergone surgery for a Lisfranc injury using screws or plates within the last 21 days might be suitable candidates for this trial.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance treatment options for future patients.

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 prior data suggests that implant removal or retention is safe for Lisfranc injuries?

Research has shown that whether implants are removed or left in after fixing a Lisfranc injury, recovery tends to be similar. Both options lead to comparable results in terms of post-treatment function.

Studies indicate that both options are generally safe. Although complications are rare, they can occur, such as the need for unexpected surgeries due to implant issues. However, these situations are uncommon.

In summary, both methods appear safe for most people, with problems being infrequent. This information may help prospective trial participants feel more comfortable about the process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial comparing implant removal and retention for Lisfranc injuries because it investigates crucial post-surgery options that could impact recovery outcomes. Typically, treatment involves surgical fixation with implants left in place permanently or removed later. This trial seeks to determine whether removing implants six months post-surgery could lead to better mobility, fewer complications, or less pain compared to leaving them in place for two years. Understanding these differences could refine recovery protocols and improve long-term results for patients with Lisfranc injuries.

What evidence suggests that this trial's treatments could be effective for Lisfranc injuries?

This trial will compare two approaches for Lisfranc injury: implant removal versus implant retention. Research has shown that whether implants are removed or retained after Lisfranc injury surgery, patients tend to experience similar recovery outcomes. In one study, 93% of patients reported high satisfaction with either option. However, joint stiffness and infections were common, affecting up to 26% and 24% of patients, respectively. More than half of the patients eventually had their implants removed, either as planned or unexpectedly. Thus, while neither approach is clearly superior, each has its own advantages and disadvantages depending on the individual case. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314232/

Outcomes in Open Reduction and Internal Fixation of ... A systematic review of outcomes following Lisfranc injury fixation: removal vs retention of metalwork. Foot Ankle Orthop. 2022;7(4): ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9558891/

A Systematic Review of Outcomes Following Lisfranc Injury ... The current study demonstrates similar functional outcomes comparing routine removal of metalwork vs planned retention following fixation for a Lisfranc injury.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0958259220300572

Lisfranc injury: A review and simplified treatment algorithm Excellent outcomes (93% patient satisfaction) have been reported with this treatment methodology [12]. 3.5.2. Operative management. Unstable or displaced ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020138325006151

Epidemiology, complications and patient-reported ... Most complications were related to posttraumatic arthrosis (26%) and infections (24%). Over half of the patients (52%) underwent implant removal ...

5. researchgate.net researchgate.net/publication/364362029_A_Systematic_Review_of_Outcomes_Following_Lisfranc_Injury_Fixation_Removal_vs_Retention_of_Metalwork

A Systematic Review of Outcomes Following Lisfranc Injury ... Of the 317 patients in the retention group, metalwork was removed in 198 cases, resulting in a 62.5% unplanned removal rate. Conclusion: In conclusion, this ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0958259223000329

Long term results and patient reported outcome measures ... Lisfranc injuries are significant life changing injuries, accounting for 0.2 % of all fractures. Accurate reduction is the only determinant of outcome. The ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/1938640020933078

Occupational Outcomes and Return to Running After ... 80% of servicemembers undergoing ORIF or primary arthrodeses for Lisfranc injuries remained on active duty or successfully completed their military service.