Full Title
A Randomized Clinical Trial evaluating Fixation Insitu vs Removal for Midfoot Lisfranc Injuries (The FIRM Trial)

Eligibility

Inclusion Criteria:

  • 18 years of age or older and skeletally mature
  • Subject has Lisfranc injury that was previously treated with screws and/or plate fixation within 21 days of initial injury
  • Subject must be enrolled in study within 6 weeks (+/-2 weeks) from time of initial fixation operation
  • The patient must be medically fit for anaesthesia
  • Subject is willing and able to provide written informed consent for trial participation
  • Subject is willing and able to comply with the study protocol including return for all follow-up evaluations

Exclusion Criteria:

  • Subject has a significant pre-existing foot injury or deformity
  • There has been loss of fixation or reduction prior to enrollment
  • Subject was treated with a primary tarsometatarsal joint fusion
  • Subject has a delay in initial treatment greater than 21 days from time of injury
  • Subject has an active infection in the area of surgical approach
  • Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time
  • Subject has a history of rheumatoid arthritis, Diabetes, metabolic bone disease (including osteoporosis actively being treated), active malignancy, pathologic fracture or other pre-existing pathologic condition affecting the Lisfranc complex
  • Subject has a high risk of death from surgery (ASA physical status Class V)
  • Subject is likely unable to maintain follow-up
  • Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
  • Subject is pregnant or planning on becoming pregnant in the following year

Contact:

PI
Dr. Chad Coles

Description

This study is a multicenter, randomized clinical trial comparing implant retention (Retention Group) to scheduled implant removal (Removal Group) in 100 skeletally mature patients with Lisfranc injuries previously treated with screw and/or plate fixation. The primary outcome measure is the validated, patient-reported Foot and Ankle Ability Measure (FAAM) at 1-year post initial Lisfranc injury. Secondary outcome measures include: 1. American Orthopedics Foot and Ankle Midfoot Score (AOFAS), 2. patient-reported Visual Analogue Scale (VAS) for Foot and Ankle, 3. range of motion, 4. radiographic assessment of Lisfranc reduction, 5. comparative cost analysis between treatment groups. This study will follow patients for 1-year post-injury.

Sample size= 100