An interventional study of Hardware removal in Closed Fracture Dislocation, Tarsometatarsal Joint and Open Fracture Dislocation, Tarsometatarsal Joint, sponsored by University of Calgary. Recruiting at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-09.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
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.
44 studies on the registry are indexed under Fractures, Closed; 4 are open to participants now.
This study's planned enrollment of 94 is above the median of 45 across 34 interventional studies indexed under Fractures, Closed.
Browse Fractures, Closed studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Removal of hardware at 6 months.
Procedure: Hardware removal
Retention of hardware at 6 months
Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.
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 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.
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
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