Foot InjuryNCT02953067

Study of Treatment of Lisfranc Injuries

A study testing Open reduction and internal fixation, Primary arthrodesis and Conservative treatment in people with Foot Injury, run by Tampere University Hospital at 1 site in Finland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Foot Injury
What is being tested?: Open reduction and internal fixation, Primary arthrodesis and Conservative treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteFinland
Study dates: Mar 2012to Aug 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Tampere University Hospital
Tampere, 33521

Other trials in Finland

About this study

Official title: 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.

Read the detailed description

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

Conditions: Foot Injury
Being tested: Open reduction and internal fixation, Primary arthrodesis, Conservative treatment
Medical subject headings: Foot Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Open reduction and internal fixationProcedure or surgery
Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis
Primary arthrodesisProcedure or surgery
Primary arthrodesis versus ORIF
Conservative treatmentProcedure or surgery
Conservative treatment versus open reduction and internal fixation

Study groups in NCT02953067
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Procedure: Conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 24 months

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Aug 2023

First posted2 Nov 2016 (estimated)
Study startMar 2012
Primary completionAug 2023
Study completionAug 2023

Why it stopped: Unable to reach the required sample size

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Foot InjuryStudies of the same condition, open and under way.
More trials run by Tampere University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02953067
Sponsor's protocol ID: R11152
Status last verified: Nov 2023
First submitted: 24 Oct 2016
Last updated: 13 Nov 2023
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 38482816
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.
PubMed 30126393

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Foot Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries
ClinicalTrials.gov ID: NCT02953067
Acronym / sponsor ID: R11152
Conditions: Foot Injury
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to reach the required sample size
Enrolment: 69 participants (actual)
Lead sponsor: Tampere University HospitalUniversity, hospital or other
Collaborators: Seinajoki Central Hospital
Study start: Mar 2012 (actual)
Primary completion: Aug 2023 (actual)
Study completion: Aug 2023 (actual)
First posted: 2 Nov 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Open reduction and internal fixation	Active comparator	Procedure: Open reduction and internal fixationAfter 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	Active comparator	Procedure: Primary arthrodesisAfter 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.
Conservative treatment	Active comparator	Procedure: Conservative treatmentNon-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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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
Affected joints TMT II- III + any other TMT
Any dislocation >2mm (fracture or TMT joint)

Key exclusion criteria (11 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Open reduction and internal fixationStratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis	Procedure or surgery	Open reduction and internal fixation
Primary arthrodesisPrimary arthrodesis versus ORIF	Procedure or surgery	Primary Arthrodesis
Conservative treatmentConservative treatment versus open reduction and internal fixation	Procedure or surgery	Conservative treatment

Primary outcome

AOFAS Midfoot Scale
Time frame: 12 months
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).
AOFAS Midfoot Scale
Time frame: 24 months
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).

8 secondary outcomes

VAS Foot and Ankle
Time frame: 12 months
VAS Foot and Ankle
Time frame: 24 months
VAS Pain
Time frame: 6 weeks
VAS Pain
Time frame: 10 weeks
VAS Pain
Time frame: 4 months
VAS Pain
Time frame: 6 months
VAS Pain
Time frame: 12 months
VAS Pain
Time frame: 24 months

Results and safety

The study was stopped early (reason given: Unable to reach the required sample size). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Derived from this study: PubMed 38482816Ponkilainen 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.
Derived from this study: PubMed 30126393Ponkilainen 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.
Individual participant dataSharing planned: No

Related trials for Foot Injury

Recruiting
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Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heikki-Jussi Laine, MD; PhD study chair

Tampere University

Tiina Kaistila, MS study chair

Tampere University

Ville Mattila, Professor study chair

Tampere University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Open reduction and internal fixation, Primary arthrodesis and Conservative treatment in people with Foot Injury, run by Tampere University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Unable to reach the required sample size). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AOFAS Midfoot Scale (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953067, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.