This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.
Foothills Medical Centre
Calgary, Alberta, Canada
RECRUITINGPeter Lougheed Centre
Calgary, Alberta, Canada
ACTIVE_NOT_RECRUITINGSouth Health Campus
Calgary, Alberta, Canada
ACTIVE_NOT_RECRUITINGAOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
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.
Time frame: 6 weeks
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
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.
Time frame: 12 weeks
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
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.
Time frame: 6 months
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
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.
Time frame: 1 year
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
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.
Time frame: 2 years
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
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Time frame: 6 weeks
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time frame: 12 weeks
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time frame: 6 months
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time frame: 1 year
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time frame: 2 years
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time frame: 6 weeks
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time frame: 12 weeks
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time frame: 6 months
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time frame: 1 year
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time frame: 2 years
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time frame: 6 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time frame: 12 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time frame: 6 months
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time frame: 1 year
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time frame: 2 years
Radiologic outcome
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.
Time frame: 2 years
Cost-effectiveness
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)
Time frame: 2 years