Clinical trial NCT02953067: Study of Treatment of Lisfranc Injuries
Official title: A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Foot Injury
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Seinajoki Central Hospital
First posted: 2016-11-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: AOFAS Midfoot Scale
timeFrame: 12 months
measure: AOFAS Midfoot Scale
timeFrame: 24 months
Secondary outcomes:
measure: VAS Foot and Ankle
timeFrame: 12 months
measure: VAS Foot and Ankle
timeFrame: 24 months
measure: VAS Pain
timeFrame: 6 weeks
measure: VAS Pain
timeFrame: 10 weeks
measure: VAS Pain
timeFrame: 4 months
measure: VAS Pain
timeFrame: 6 months
measure: VAS Pain
timeFrame: 12 months
measure: VAS Pain
timeFrame: 24 months
Other outcomes:
measure: Additional procedures or complications
timeFrame: up to 24months
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University
name: Heikki-Jussi Laine, MD; PhD
role: STUDY_CHAIR
affiliation: Tampere University
name: Tiina Kaistila, MS
role: STUDY_CHAIR
affiliation: Tampere University
name: Ville Mattila, Professor
role: STUDY_CHAIR
affiliation: Tampere University
name: Antti Paakkala, MD;PhD
role: STUDY_CHAIR
affiliation: Tampere University
name: Heikki Mäenpää, Docent
role: STUDY_CHAIR
affiliation: Dextra Fertility Clinic
name: Mikko Kirjavainen, MD; PhD
role: STUDY_CHAIR
affiliation: Seinajoki Central Hospital
name: Janne Jousmäki, MD
role: STUDY_CHAIR
affiliation: Seinajoki Central Hospital
name: Olli Väistö, MD; PhD
role: STUDY_CHAIR
References:
citation: 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.