Study of Treatment of Lisfranc Injuries

Study Overview
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Brief Summary
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This trial is designed to compare different treatments on Lisfranc fractures. The trial consist of 2 different strata. Stratum 1: In mild injuries the comparison is between conservative treatment and operative treatment with open reduction and internal fixation (ORIF). Stratum 2: In severe injuries the comparison is between operative treatment with open reduction and internal fixation (ORIF) and primary arthrodesis. The primary outcome measure will be AOFAS Midfoot Score, and secondary outcome measure will be VAS Foot and Ankle.

Detailed Description
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The aim of this study is to find out the most effective way to treat Lisfranc injuries

Official Title
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A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries

Conditions
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Foot Injury

Intervention / Treatment
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* Procedure: Open reduction and internal fixation
* Procedure: Primary arthrodesis
* Procedure: Conservative treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stratum 1: Nondislocated fractures affecting tarsometatarsal (TMT) joints II and III Dislocation <5mm between medial cuneiforme and base of II metatarsal (MT) No fractures affecting TMT joints IV and V Stratum 2: Affected joints TMT II- III + any other TMT Any dislocation >2mm (fracture or TMT joint) Dislocation >5mm between medial cuneiforme and base of II MT Exclusion Criteria: Open fractures Extra-articular metatarsal (MT) fractures Extremely comminuted fractures with bone loss, and slight chance of gaining proper reduction with screws Patients with multiple fractures Patients with weak co-operation (dementia, alcohol use, etc.) Patients with significant neuropathy or some other neurological condition, diabetes and rheumatoid arthritis Patients with severe circulatory disorder of the lower limb Injuries over 14 days Patients with previous foot injury or surgery Pregnancy Patients who refuse to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: Open reduction and internal fixation<br>After operative treatment non-weightbearing cast immobilisation for 6 weeks. Cast will be changed after 2 weeks. After the 6 weeks cast will be replaced with orthotics. Orthotics will remain for 4 weeks. | Procedure: Open reduction and internal fixation<br>* Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis<br>|
| Active Comparator: Primary Arthrodesis<br>After operative treatment non-weightbearing cast immobilisation for 6 weeks. Cast will be changed after 2 weeks. After the 6 weeks cast will be replaced with orthotics. Orthotics will remain for 4 weeks. | Procedure: Primary arthrodesis<br>* Primary arthrodesis versus ORIF<br>|
| Active Comparator: Conservative treatment<br>Non-weightbearing cast immobilisation for 6 weeks. Cast will be changed after 2 weeks. After the 6 weeks cast will be replaced with orthotics. Orthotics will remain for 4 weeks. | Procedure: Conservative treatment<br>* Conservative treatment versus open reduction and internal fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS Midfoot Scale | Between group difference in the functional outcome of the foot measured with AOFAS Midfoot Scale which is a subjective and objective evaluation of the midfoot based on questions in function (45 points), pain (40 points), and alignment (15 points) with a total score between 0 (worst score) and 100 (perfect score). | 12 months | 
| AOFAS Midfoot Scale | Between group difference in the functional outcome of the foot measured with AOFAS Midfoot Scale which is a subjective and objective evaluation of the midfoot based on questions in function (45 points), pain (40 points), and alignment (15 points) with a total score between 0 (worst score) and 100 (perfect score). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS Foot and Ankle | Between group differences in pain and function of the foot measured with Visual Analog Scale of the Foot and Ankle (FA VAS). FA VAS scale is a self-administered patient questionnaire based on 20 questions in three different question categories (pain, function and other complaints). The total value of all questions is 2000. This total value is divided with 20 resulting in a possible score from 0 to 100 points, where 100 is the perfect score. | 12 months | 
| VAS Foot and Ankle | Between group differences in pain and function of the foot measured with Visual Analog Scale of the Foot and Ankle (FA VAS). FA VAS scale is a self-administered patient questionnaire based on 20 questions in three different question categories (pain, function and other complaints). The total value of all questions is 2000. This total value is divided with 20 resulting in a possible score from 0 to 100 points, where 100 is the perfect score. | 24 months | 
| VAS Pain | Between group difference in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 6 weeks | 
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 10 weeks | 
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 4 months | 
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 6 months | 
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 12 months | 
| VAS Pain | Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). | 24 months |