Foot Injury
Conditions
Brief summary
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
The aim of this study is to find out the most effective way to treat Lisfranc injuries
Interventions
PROCEDUREOpen reduction and internal fixation
Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis
PROCEDUREPrimary arthrodesis
Primary arthrodesis versus ORIF
PROCEDUREConservative treatment
Conservative treatment versus open reduction and internal fixation
Sponsors
Seinajoki Central Hospital
Tampere University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AOFAS Midfoot Scale | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Foot and Ankle | 12 months | 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. |
| VAS Pain | 6 weeks | Between group difference in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Additional procedures or complications | up to 24months | Number of patients with any additional procedure or complication of the treatment (implant removal, implant failure, any other reason of reoperation or complication of the treatment) |
Countries
Finland
Outcome results
None listed