Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint
Conditions
Brief summary
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
Detailed 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.
Interventions
PROCEDUREHardware removal
Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.
Sponsors
Calgary Orthopaedic Research and Education Fund
Memorial University of Newfoundland
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score | 6 weeks | Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score. |
| VAS-FA - Visual Analog Scale Foot and Ankle | 6 weeks | Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100. |
| SF-36 | 6 weeks | Patient reported measure on physical and mental status on 36 items across eight health domains. |
| VAS - Visual Analogue Scale (Patient Satisfaction) | 6 weeks | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiologic outcome | 2 years | Radiographic measurement of the gap between 1st and 2nd metatarsals and maintenance of reduction on static and weight bearing xrays from index films at enrollment to 2 years. |
| Cost-effectiveness | 2 years | Cost of treatment and complications plus incremental costs up to 2 year follow up will be collected and compared with Quality Adjusted Life Years (QALYs) |
Countries
Canada
Contacts
Primary ContactKarin Lienhard, PhD
Outcome results
None listed