What side effects are associated with this type of intervention?

The most common treatments for Lisfranc injuries, particularly surgical interventions like fixation in-situ and implant removal, can have several side effects. These include potential surgical complications such as infection, hardware failure, and the need for additional surgeries. Implant removal can also lead to increased healthcare costs, lost time from work, and possible functional impairment.

What prior FDA approvals exist?

There are currently no specific FDA-approved treatments or guidelines for the removal versus retention of implants in Lisfranc injuries. The management of these injuries typically involves surgical intervention to stabilize the joint, but the decision to remove or retain implants post-surgery lacks robust evidence from prospective randomized studies. Consequently, treatment approaches are based on clinical judgment and patient-specific factors rather than standardized protocols.

What other types of research exist?

As of now, there are no established evidence-based guidelines for implant removal versus retention in Lisfranc injuries. However, promising novel alternatives that could be considered for treatment in 2024 include the development of bioresorbable implants, which gradually dissolve and eliminate the need for a second surgery to remove hardware. Additionally, advancements in minimally invasive surgical techniques and the use of 3D-printed custom implants tailored to the patient's anatomy may offer improved functional recovery and reduced complications. These innovations are still under research and clinical trials, but they hold potential for future treatment protocols.

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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

Must not have

Active infection in the area of surgical approach

High risk of death from surgery (ASA physical status Class V)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am healthy enough to undergo anesthesia.

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I am 18 years old or older and my bones have stopped growing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an infection where I might have surgery.

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I am at high risk for surgery complications.

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I have a history of conditions like rheumatoid arthritis or diabetes affecting my foot.

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I have a serious foot injury or deformity.

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I had surgery to fuse joints in my foot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Foot and Ankle Ability Measure (FAAM)

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Removal GroupActive Control1 Intervention

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

Group II: 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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Lisfranc injuries involve surgical interventions such as fixation and, in some cases, subsequent implant removal. Fixation typically involves the use of screws or plates to stabilize the tarsometatarsal joint, allowing for proper alignment and healing of the injured ligaments and bones. This stabilization is crucial for restoring foot function and preventing long-term complications such as arthritis or chronic pain. Implant removal, on the other hand, is considered to potentially reduce the risk of hardware-related complications, such as irritation or infection, and may improve functional outcomes. The decision between retaining or removing implants is significant for Lisfranc injury patients as it can impact their recovery time, complication rates, and overall functional recovery.