Study of Treatment of Lisfranc Injuries

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.

Conditions

• Foot Injury

Interventions

PROCEDURE

Open reduction and internal fixation

Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis

PROCEDURE

Primary arthrodesis

Primary arthrodesis versus ORIF

PROCEDURE

Conservative treatment

Conservative treatment versus open reduction and internal fixation

Sponsors & Collaborators

• Seinajoki Central Hospital

  collaborator OTHER

• Tampere University Hospital

  lead OTHER

Principal Investigators

• Heikki-Jussi Laine, MD; PhD · Tampere University

• Tiina Kaistila, MS · Tampere University

• Ville Mattila, Professor · Tampere University

• Antti Paakkala, MD;PhD · Tampere University

• Heikki Mäenpää, Docent · Tampere University

• Mikko Kirjavainen, MD; PhD · Dextra Fertility Clinic

• Janne Jousmäki, MD · Seinajoki Central Hospital

• Olli Väistö, MD; PhD · Seinajoki Central Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• Finland

Study Locations