Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
69 participants
INTERVENTIONAL
2012-03-31
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Open reduction and internal fixation
Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus 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.
Primary arthrodesis
Primary arthrodesis versus ORIF
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.
Conservative treatment
Conservative treatment versus open reduction and internal fixation
Interventions
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Open reduction and internal fixation
Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis
Primary arthrodesis
Primary arthrodesis versus ORIF
Conservative treatment
Conservative treatment versus open reduction and internal fixation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Seinajoki Central Hospital
OTHER
Tampere University Hospital
OTHER
Responsible Party
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Heidi Haapasalo
MD, PhD
Principal Investigators
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Heikki-Jussi Laine, MD; PhD
Role: STUDY_CHAIR
Tampere University
Tiina Kaistila, MS
Role: STUDY_CHAIR
Tampere University
Ville Mattila, Professor
Role: STUDY_CHAIR
Tampere University
Antti Paakkala, MD;PhD
Role: STUDY_CHAIR
Tampere University
Heikki Mäenpää, Docent
Role: STUDY_CHAIR
Tampere University
Mikko Kirjavainen, MD; PhD
Role: STUDY_CHAIR
Dextra Fertility Clinic
Janne Jousmäki, MD
Role: STUDY_CHAIR
Seinajoki Central Hospital
Olli Väistö, MD; PhD
Role: STUDY_CHAIR
Seinajoki Central Hospital
Locations
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Tampere University Hospital
Tampere, , Finland
Countries
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References
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Ponkilainen V, Maenpaa H, Laine HJ, Partio N, Vaisto O, Jousmaki J, Mattila VM, Haapasalo H. Open Reduction Internal Fixation vs Primary Arthrodesis for Displaced Lisfranc Injuries: A Multicenter Randomized Controlled Trial. Foot Ankle Int. 2024 Jun;45(6):612-620. doi: 10.1177/10711007241232667. Epub 2024 Mar 14.
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.
Other Identifiers
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R11152
Identifier Type: -
Identifier Source: org_study_id
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