Study of Treatment of Lisfranc Injuries

Tampere University Hospital

Status: Terminated

Conditions: Foot Injury

Treatments: Procedure: Conservative treatment; Procedure: Primary arthrodesis; Procedure: Open reduction and internal fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT02953067

R11152

Details and patient eligibility

About

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.

Full description

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

Enrollment: 69 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 3 patient groups

Open reduction and internal fixation

Active Comparator group

Description:

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.

Treatment:

Procedure: Open reduction and internal fixation

Primary Arthrodesis

Active Comparator group

Description:

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.

Treatment:

Procedure: Primary arthrodesis

Conservative treatment

Active Comparator group

Description:

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.

Treatment:

Procedure: Conservative treatment