Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

Study Overview
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Brief Summary
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This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).

Detailed Description
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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.

Official Title
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A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

Conditions
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Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint

Intervention / Treatment
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* Procedure: Hardware removal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hardware Removal<br>Removal of hardware at 6 months. | Procedure: Hardware removal<br>* Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.<br>|
| No Intervention: Hardware Retention<br>Retention of hardware at 6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 6 weeks | 
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 12 weeks | 
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 6 months | 
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 1 year | 
| SF-36 | Patient reported measure on physical and mental status on 36 items across eight health domains. | 2 years | 
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 6 weeks | 
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 12 weeks | 
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 6 months | 
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 1 year | 
| VAS - Visual Analogue Scale (Patient Satisfaction) | Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |