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