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Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries (FIRM)

Primary Purpose

Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hardware removal
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Closed Fracture Dislocation, Tarsometatarsal Joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has Lisfranc injury that was treated within 28 days of injury.
  • Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation.
  • The patient must be medically fit for anesthesia
  • Subject is willing and able to provide written informed consent for trial participation
  • Subject is willing and able to comply with the study protocol including return for all follow-up evaluations
  • Subject may have a bony, ligamentous, or combined lisfranc injury
  • Demonstrated instability of the lisfranc complex on static, stress view or CT radiography.
  • Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon
  • Adequate reduction to within 1mm of lisfranc complex at time of fixation
  • Hardware across the midfoot (tarsal-metatarsal joints 1-3)

Exclusion Criteria:

  • Subject has a significant pre-existing foot injury
  • Subject has a delay in initial treatment greater than 28 days from time of injury
  • Subject has an active infection in the area of surgical approach requiring surgical debridement
  • Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury)
  • Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any other pre-existing pathologic condition affecting the Lisfranc complex
  • Subject has a high risk of death from surgery (ASA physical status Class V)
  • Subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.)
  • Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
  • Subject is pregnant
  • There has been loss of fixation or reduction prior to enrollment
  • Previous corrective foot surgery
  • Associated fracture of calcaneus, talus, or tibial plafond.
  • Pathologic fracture
  • Loss of fixation or reduction prior to enrollment

Sites / Locations

  • Foothills Medical CentreRecruiting
  • Peter Lougheed Centre
  • South Health Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hardware Removal

Hardware Retention

Arm Description

Removal of hardware at 6 months.

Retention of hardware at 6 months

Outcomes

Primary Outcome Measures

AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
VAS-FA - Visual Analog Scale Foot and Ankle
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.

Secondary Outcome Measures

Radiologic outcome
Radiographic measurement of the gap between 1st and 2nd metatarsals and maintenance of reduction on static and weight bearing xrays from index films at enrollment to 2 years.
Cost-effectiveness
Cost of treatment and complications plus incremental costs up to 2 year follow up will be collected and compared with Quality Adjusted Life Years (QALYs)

Full Information

First Posted
February 10, 2015
Last Updated
November 4, 2022
Sponsor
University of Calgary
Collaborators
Calgary Orthopaedic Research and Education Fund, Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT02374944
Brief Title
Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Acronym
FIRM
Official Title
A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Calgary Orthopaedic Research and Education Fund, Memorial University of Newfoundland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
Detailed Description
Eligible patients will be randomized to one of two treatment arms: Hardware removal at 6 months or Hardware retention for a minimum of 2 years. Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (RH) or hardware retention (HR). Outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hardware Removal
Arm Type
Experimental
Arm Description
Removal of hardware at 6 months.
Arm Title
Hardware Retention
Arm Type
No Intervention
Arm Description
Retention of hardware at 6 months
Intervention Type
Procedure
Intervention Name(s)
Hardware removal
Intervention Description
Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.
Primary Outcome Measure Information:
Title
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Description
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
Time Frame
6 weeks
Title
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Description
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
Time Frame
12 weeks
Title
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Description
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
Time Frame
6 months
Title
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Description
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
Time Frame
1 year
Title
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Description
Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.
Time Frame
2 years
Title
VAS-FA - Visual Analog Scale Foot and Ankle
Description
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time Frame
6 weeks
Title
VAS-FA - Visual Analog Scale Foot and Ankle
Description
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time Frame
12 weeks
Title
VAS-FA - Visual Analog Scale Foot and Ankle
Description
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time Frame
6 months
Title
VAS-FA - Visual Analog Scale Foot and Ankle
Description
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time Frame
1 year
Title
VAS-FA - Visual Analog Scale Foot and Ankle
Description
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
Time Frame
2 years
Title
SF-36
Description
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time Frame
6 weeks
Title
SF-36
Description
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time Frame
12 weeks
Title
SF-36
Description
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time Frame
6 months
Title
SF-36
Description
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time Frame
1 year
Title
SF-36
Description
Patient reported measure on physical and mental status on 36 items across eight health domains.
Time Frame
2 years
Title
VAS - Visual Analogue Scale (Patient Satisfaction)
Description
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time Frame
6 weeks
Title
VAS - Visual Analogue Scale (Patient Satisfaction)
Description
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time Frame
12 weeks
Title
VAS - Visual Analogue Scale (Patient Satisfaction)
Description
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time Frame
6 months
Title
VAS - Visual Analogue Scale (Patient Satisfaction)
Description
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time Frame
1 year
Title
VAS - Visual Analogue Scale (Patient Satisfaction)
Description
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Radiologic outcome
Description
Radiographic measurement of the gap between 1st and 2nd metatarsals and maintenance of reduction on static and weight bearing xrays from index films at enrollment to 2 years.
Time Frame
2 years
Title
Cost-effectiveness
Description
Cost of treatment and complications plus incremental costs up to 2 year follow up will be collected and compared with Quality Adjusted Life Years (QALYs)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has Lisfranc injury that was treated within 28 days of injury. Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation. The patient must be medically fit for anesthesia Subject is willing and able to provide written informed consent for trial participation Subject is willing and able to comply with the study protocol including return for all follow-up evaluations Subject may have a bony, ligamentous, or combined lisfranc injury Demonstrated instability of the lisfranc complex on static, stress view or CT radiography. Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon Adequate reduction to within 1mm of lisfranc complex at time of fixation Hardware across the midfoot (tarsal-metatarsal joints 1-3) Exclusion Criteria: Subject has a significant pre-existing foot injury Subject has a delay in initial treatment greater than 28 days from time of injury Subject has an active infection in the area of surgical approach requiring surgical debridement Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury) Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any other pre-existing pathologic condition affecting the Lisfranc complex Subject has a high risk of death from surgery (ASA physical status Class V) Subject is likely unable to maintain follow-up(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.) Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires Subject is pregnant There has been loss of fixation or reduction prior to enrollment Previous corrective foot surgery Associated fracture of calcaneus, talus, or tibial plafond. Pathologic fracture Loss of fixation or reduction prior to enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Lienhard, PhD
Phone
403-944-2932
Email
karin.lienhard@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Duffy, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Lienhard, PhD
Phone
4039444594
Email
karin.lienhard@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Paul Duffy, MD
First Name & Middle Initial & Last Name & Degree
Robert Korley, MD
First Name & Middle Initial & Last Name & Degree
Christopher R Martin, MD
First Name & Middle Initial & Last Name & Degree
Richard Buckley, MD
First Name & Middle Initial & Last Name & Degree
Prism Schneider, MD
Facility Name
Peter Lougheed Centre
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
South Health Campus
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

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