Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries (FIRM)

University of Calgary

Status

Enrolling

Conditions

Closed Fracture Dislocation, Tarsometatarsal Joint

Open Fracture Dislocation, Tarsometatarsal Joint

Treatments

Procedure: Hardware removal

Study type

Interventional

Funder types

Other

Identifiers

NCT02374944

REB14-0625

Details and patient eligibility

About

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

Full 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.

Enrollment

94 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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