Closed Fracture Dislocation, Tarsometatarsal Joint Clinical Trial
— FIRMOfficial title:
A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
| Status | Recruiting |
| Enrollment | 94 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Foothills Medical Centre | Calgary | Alberta |
| Canada | Peter Lougheed Centre | Calgary | Alberta |
| Canada | South Health Campus | Calgary | Alberta |
| Lead Sponsor | Collaborator |
|---|---|
| University of Calgary | Calgary Orthopaedic Research and Education Fund, Memorial University of Newfoundland |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 6 weeks | |
| Primary | 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. | 12 weeks | |
| Primary | 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. | 6 months | |
| Primary | 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. | 1 year | |
| Primary | 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. | 2 years | |
| Primary | 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. | 6 weeks | |
| Primary | 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. | 12 weeks | |
| Primary | 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. | 6 months | |
| Primary | 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. | 1 year | |
| Primary | 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. | 2 years | |
| Primary | SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 6 weeks | |
| Primary | SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 12 weeks | |
| Primary | SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 6 months | |
| Primary | SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 1 year | |
| Primary | SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 2 years | |
| Primary | VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 6 weeks | |
| Primary | VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 12 weeks | |
| Primary | VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 6 months | |
| Primary | VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 1 year | |
| Primary | VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 2 years | |
| Secondary | 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. | 2 years | |
| Secondary | 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) | 2 years |