A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Foot Injury
- Sponsor
- Tampere University Hospital
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- AOFAS Midfoot Scale
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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
Investigators
Heidi Haapasalo
MD, PhD
Tampere University Hospital
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
AOFAS Midfoot Scale
Time Frame: 24 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 Outcomes
- VAS Foot and Ankle(24 months)
- VAS Pain(24 months)