FIRM: Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Study Details
Study Description
Brief Summary
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hardware Removal Removal of hardware at 6 months. |
Procedure: Hardware removal
|
| No Intervention: Hardware Retention Retention of hardware at 6 months |
Outcome Measures
Primary Outcome Measures
- 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.
- AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score [12 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.
- AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score [6 months]
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.
- AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score [1 year]
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.
- AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score [2 years]
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.
- VAS-FA - Visual Analog Scale Foot and Ankle [12 weeks]
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
- VAS-FA - Visual Analog Scale Foot and Ankle [6 months]
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
- VAS-FA - Visual Analog Scale Foot and Ankle [1 year]
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
- VAS-FA - Visual Analog Scale Foot and Ankle [2 years]
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.
- SF-36 [12 weeks]
Patient reported measure on physical and mental status on 36 items across eight health domains.
- SF-36 [6 months]
Patient reported measure on physical and mental status on 36 items across eight health domains.
- SF-36 [1 year]
Patient reported measure on physical and mental status on 36 items across eight health domains.
- SF-36 [2 years]
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.
- VAS - Visual Analogue Scale (Patient Satisfaction) [12 weeks]
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
- VAS - Visual Analogue Scale (Patient Satisfaction) [6 months]
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
- VAS - Visual Analogue Scale (Patient Satisfaction) [1 year]
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
- VAS - Visual Analogue Scale (Patient Satisfaction) [2 years]
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Secondary Outcome Measures
- 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)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Foothills Medical Centre | Calgary | Alberta | Canada | |
| 2 | Peter Lougheed Centre | Calgary | Alberta | Canada | |
| 3 | South Health Campus | Calgary | Alberta | Canada |
Sponsors and Collaborators
- University of Calgary
- Calgary Orthopaedic Research and Education Fund
- Memorial University of Newfoundland
Investigators
- Principal Investigator: Paul J Duffy, MD, University of Calgary
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REB14-0625