Back to resultsStudy of Treatment of Lisfranc Injuries
Primary Purpose
Foot Injury
Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Open reduction and internal fixation
Primary arthrodesis
Conservative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Foot Injury
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
Sites / Locations
- Tampere University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Open reduction and internal fixation
Primary Arthrodesis
Conservative treatment
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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.
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.
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).
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).
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).
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).
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).
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).
Full Information
NCT ID
NCT02953067
First Posted
October 24, 2016
Last Updated
September 1, 2019
Sponsor
Tampere University Hospital
Collaborators
Seinajoki Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02953067
Brief Title
Study of Treatment of Lisfranc Injuries
Official Title
A Multi-center, Prospective, Randomised Study of Treatment of Lisfranc Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Recruiting
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
Collaborators
Seinajoki Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open reduction and internal fixation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Primary Arthrodesis
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conservative treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Open reduction and internal fixation
Intervention Description
Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis
Intervention Type
Procedure
Intervention Name(s)
Primary arthrodesis
Intervention Description
Primary arthrodesis versus ORIF
Intervention Type
Procedure
Intervention Name(s)
Conservative treatment
Intervention Description
Conservative treatment versus open reduction and internal fixation
Primary Outcome Measure Information:
Title
AOFAS Midfoot Scale
Description
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).
Time Frame
12 months
Title
AOFAS Midfoot Scale
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
VAS Foot and Ankle
Description
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.
Time Frame
12 months
Title
VAS Foot and Ankle
Description
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.
Time Frame
24 months
Title
VAS Pain
Description
Between group difference in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
Time Frame
6 weeks
Title
VAS Pain
Description
Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
Time Frame
10 weeks
Title
VAS Pain
Description
Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
Time Frame
4 months
Title
VAS Pain
Description
Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
Time Frame
6 months
Title
VAS Pain
Description
Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
Time Frame
12 months
Title
VAS Pain
Description
Between group differences in foot pain measured with Visual Analog Scale with a score of zero (no pain) to 100 (worst possible pain).
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Additional procedures or complications
Description
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)
Time Frame
up to 24months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Haapasalo, MD; PhD
Phone
+3583311611
Email
heidi.haapasalo@pshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Ville Ponkilainen, BM
Phone
+3583311611
Email
vp96505@student.uta.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki-Jussi Laine, MD; PhD
Organizational Affiliation
Tampere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tiina Kaistila, MS
Organizational Affiliation
Tampere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ville Mattila, Professor
Organizational Affiliation
Tampere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antti Paakkala, MD;PhD
Organizational Affiliation
Tampere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heikki Mäenpää, Docent
Organizational Affiliation
Tampere University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mikko Kirjavainen, MD; PhD
Organizational Affiliation
Dextra Fertility Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Janne Jousmäki, MD
Organizational Affiliation
Seinajoki Central Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olli Väistö, MD; PhD
Organizational Affiliation
Seinajoki Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Haapasalo, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30126393
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.
Results Reference
derived
Learn more about this trial
Study of Treatment of Lisfranc Injuries
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