TerminatedNot Applicable

Study of Treatment of Lisfranc Injuries

Stopped: Unable to reach the required sample size

Finland69 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

AOFAS Midfoot Scale

Timeframe: 12 months

AOFAS Midfoot Scale

Timeframe: 24 months

Trial details

NCT IDNCT02953067

SponsorTampere University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08

View on ClinicalTrials.gov More Foot Injury trials