NCT02953067

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

11.4 years

First QC Date

October 24, 2016

Last Update Submit

November 9, 2023

Conditions

Foot Injury

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • VAS Foot and Ankle

    12 months

  • VAS Foot and Ankle

    24 months

  • VAS Pain

    6 weeks

  • VAS Pain

    10 weeks

  • VAS Pain

    4 months

  • +3 more secondary outcomes

Other Outcomes (1)

  • Additional procedures or complications

    up to 24months

Study Arms (3)

Open reduction and internal fixation

ACTIVE COMPARATOR

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

Primary Arthrodesis

ACTIVE COMPARATOR

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

Conservative treatment

ACTIVE COMPARATOR

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

Interventions

Open reduction and internal fixationPROCEDURE

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

Open reduction and internal fixation
Primary arthrodesisPROCEDURE

Primary arthrodesis versus ORIF

Primary Arthrodesis
Conservative treatmentPROCEDURE

Conservative treatment versus open reduction and internal fixation

Conservative treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (2)

  • 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.

    PMID: 38482816DERIVED

  • 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.

    PMID: 30126393DERIVED

MeSH Terms

Conditions

Foot Injuries

Interventions

Open Fracture ReductionFracture Fixation, InternalConservative Treatment

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 2, 2016

Study Start

March 1, 2012

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)