Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).

Eligible patients will be randomized to one of two treatment arms: Hardware removal at 6 months or Hardware retention for a minimum of 2 years.

Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (RH) or hardware retention (HR).

Outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.

Inclusion Criteria:

• Subject has Lisfranc injury that was treated within 28 days of injury.
• Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation.
• The patient must be medically fit for anesthesia
• 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
• Subject may have a bony, ligamentous, or combined lisfranc injury
• Demonstrated instability of the lisfranc complex on static, stress view or CT radiography.
• Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon
• Adequate reduction to within 1mm of lisfranc complex at time of fixation
• Hardware across the midfoot (tarsal-metatarsal joints 1-3)

Exclusion Criteria:

• Subject has a significant pre-existing foot injury
• Subject has a delay in initial treatment greater than 28 days from time of injury
• Subject has an active infection in the area of surgical approach requiring surgical debridement
• Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury)
• Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any 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(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.)
• Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
• Subject is pregnant
• There has been loss of fixation or reduction prior to enrollment
• Previous corrective foot surgery
• Associated fracture of calcaneus, talus, or tibial plafond.
• Pathologic fracture
• Loss of fixation or reduction prior to enrollment