Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Closed Fracture Dislocation, Tarsometatarsal Joint | Open Fracture Dislocation, Tarsometatarsal JointThis study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
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
Study Location
South Health Campus
South Health CampusCalgary, Alberta
Canada
Contact Study Team
Foothills Medical Centre
Foothills Medical CentreCalgary, Alberta
Canada
Contact Study Team
Peter Lougheed Centre
Peter Lougheed CentreCalgary, Alberta
Canada
Contact Study Team
- Study Sponsored By
- University of Calgary
- Participants Required
- More Information
- Study ID:
NCT02374944