Study of Treatment of Lisfranc Injuries

A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries

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.

Study Overview

• Status: Terminated
• Conditions: Foot Injury
• Intervention / Treatment: Procedure: Open reduction and internal fixation; Procedure: Primary arthrodesis; Procedure: Conservative treatment

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Haapasalo, MD; PhD; Phone Number: +3583311611; Email: heidi.haapasalo@pshp.fi
• Study Contact Backup: Name: Ville Ponkilainen, BM; Phone Number: +3583311611; Email: vp96505@student.uta.fi

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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.	Procedure: Primary arthrodesis; Primary arthrodesis versus ORIF
Active Comparator: 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.	Procedure: Conservative treatment; Conservative treatment versus open reduction and internal fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS Midfoot Scale	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).	12 months
AOFAS Midfoot Scale	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).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Foot and Ankle	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.	12 months
VAS Foot and Ankle	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.	24 months
VAS Pain	Between group difference in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).	6 weeks
VAS Pain	Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).	10 weeks
VAS Pain	Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).	4 months
VAS Pain	Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).	6 months
VAS Pain	Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).	12 months
VAS Pain	Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional procedures or complications	Number of patients with any additional procedure or complication of the treatment (implant removal, implant failure, any other reason of reoperation or complication of the treatment)	up to 24months

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Seinajoki Central Hospital
• Investigators: Study Chair: Heikki-Jussi Laine, MD; PhD, Tampere University; Study Chair: Tiina Kaistila, MS, Tampere University; Study Chair: Ville Mattila, Professor, Tampere University; Study Chair: Antti Paakkala, MD;PhD, Tampere University; Study Chair: Heikki Mäenpää, Docent, Tampere University; Study Chair: Mikko Kirjavainen, MD; PhD, Dextra Fertility Clinic; Study Chair: Janne Jousmäki, MD, Seinajoki Central Hospital; Study Chair: Olli Väistö, MD; PhD, Seinajoki Central Hospital

Publications and helpful links

General Publications

• Ponkilainen VT, Mattila VM, Laine HJ, Paakkala A, Maenpaa HM, Haapasalo HH. Nonoperative, open reduction and internal fixation or primary arthrodesis in the treatment of Lisfranc injuries: a prospective, randomized, multicenter trial - study protocol. BMC Musculoskelet Disord. 2018 Aug 21;19(1):301. doi: 10.1186/s12891-018-2222-4.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: November 1, 2016
• First Posted (Estimated): November 2, 2016

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Foot Injuries
• Other Study ID Numbers: R11152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO