Study of Treatment of Lisfranc Injuries

Not Applicable

Terminated

• Conditions: Foot Injury
• Interventions: Procedure: Conservative treatment; Procedure: Primary arthrodesis; Procedure: Open reduction and internal fixation

• Registration Number: NCT02953067
• Lead Sponsor: Tampere University Hospital

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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-02
• Primary Completion: 2023-08
• Study Completion: 2023-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Conservative 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.
Primary Arthrodesis	Primary arthrodesis	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.
Open reduction and internal fixation	Open reduction and internal fixation	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.

Primary Outcome Measures

Name	Time	Method
AOFAS Midfoot Scale	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 Outcome Measures

Name	Time	Method
VAS Foot and Ankle	24 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	24 months	Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland