Fixation In-situ vs Removal for Midfoot Lisfranc Injuries (NCT03694288) | Clinical Trial Compass
UnknownNot Applicable
Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
Canada100 participantsStarted 2017-09-07
Plain-language summary
Injuries to the midfoot tarsometatarsal joint, or Lisfranc joint, are notoriously debilitating. Poor functional outcomes following Lisfranc injuries have motivated surgeons to look for potential improvements in post-operative care. There are currently no evidence-based guidelines to direct implant removal for patients with operatively treated Lisfranc injuries. Routine implant removal has significant implications related to health care costs, lost time from work, potential surgical complications, and possibly functional impairment. Therefore, stakeholders including patients, surgeons, employers, and administrators will benefit from evidence-based guidelines for implant removal following operatively treated Lisfranc injuries. To date, there has not been a prospective randomized study evaluating the efficacy of implant removal compared with implant retention for Lisfranc injuries. The aim of this study is to directly compare patient-reported and radiographic outcomes, in order to provide robust evidence for optimal post-operative treatment regimens regarding implant removal or retention for operatively treated Lisfranc injuries.
Who can participate
Age range18 Years
SexALL
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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 difficult…