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Fixation In-situ vs Removal for Midfoot Lisfranc Injuries (FIRM)

Primary Purpose

Lisfranc Injuries

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

About this trial

This is an interventional treatment trial for Lisfranc Injuries focused on measuring Lisfranc

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older and skeletally mature
  • Subject has Lisfranc injury that was previously treated with screws and/or plate fixation within 21 days of initial injury
  • Subject must be enrolled in study within 6 weeks (+/-2 weeks) from time of initial fixation operation
  • The patient must be medically fit for anaesthesia
  • 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

Exclusion Criteria:

  • Subject has a significant pre-existing foot injury or deformity
  • There has been loss of fixation or reduction prior to enrollment
  • Subject was treated with a primary tarsometatarsal joint fusion
  • Subject has a delay in initial treatment greater than 21 days from time of injury
  • Subject has an active infection in the area of surgical approach
  • Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time
  • Subject has a history of rheumatoid arthritis, Diabetes, metabolic bone disease (including osteoporosis actively being treated), active malignancy, pathologic fracture or 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
  • Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
  • Subject is pregnant or planning on becoming pregnant in the following year

Sites / Locations

  • University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Removal Group

Retention Group

Arm Description

The implant removal group will have surgery scheduled 6 months after their initial surgical fixation.

The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery.

Outcomes

Primary Outcome Measures

Foot and Ankle Ability Measure (FAAM)
FAAM is a patient-reported outcome tool used to assess physical function at 24 months post initial Lisfranc surgery. This instrument includes 2 sub-scales: activities of daily living sub scale of 21 items and sport sub scale of 8 items. Answers for both scales are based on a Likert scale (4-0) of: 4) No difficulty, 3) Slight difficulty, 2) Moderate difficulty, 1) Extreme difficulty, and 0) Unable to do. Questions for which "N/A" is indicated are not counted. Two scores are reported, one for each sub scale. To calculate the score for either sub scale, the total number of points are added, divided by the number of possible points (84 for ADL and 32 for sports), and multiplied by 100. Higher scores reflect a higher level of physical function.

Secondary Outcome Measures

American Orthopedics Foot and Ankle Midfoot Score (AOFAS)
AOFAS is a surgeon-administered questionnaire, used for assessment of pain, function and alignment. The total score is reported. Scores range from 0 to 100, with a healthy midfoot receiving 100 points
Patient-reported Visual Analogue Scale (VAS) for Foot and Ankle
VAS for Foot and Ankle is a validated tool for assessing pain intensity specific to foot injuries. The patient is asked to mark their current situation on a 10 cm line with anchor statements on the left (negative outcome) and on the right (positive outcome). Longer distances (from the "negative outcome" anchor point) represent a better outcome.
Range of motion (ROM)
Assessed buy surgeon
Radiographic assessment of Lisfranc reduction
Maintenance of reduction and degree of arthritic changes across Lisfranc complex (gap between 1st and 2nd metatarsals, between the lateral aspect of the medial cuneiform to the medial aspect of second metatarsal) will be assessed by comparison of index Xrays upon enrollment and follow-up X-rays.
Comparative cost analysis between treatment groups
Comparative cost of treatment and any complications plus incremental costs up to 2-year follow-up will be collected and compared between groups.

Full Information

First Posted
October 1, 2018
Last Updated
July 7, 2022
Sponsor
University of Calgary
Collaborators
Memorial University of Newfoundland
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1. Study Identification

Unique Protocol Identification Number
NCT03694288
Brief Title
Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
Acronym
FIRM
Official Title
The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
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
Injuries to the midfoot tarsometatarsal joint, or Lisfranc joint, are notoriously debilitating. Poor functional outcomes following Lisfranc injuries have motivated surgeons to look for potential improvements in post-operative care. There are currently no evidence-based guidelines to direct implant removal for patients with operatively treated Lisfranc injuries. Routine implant removal has significant implications related to health care costs, lost time from work, potential surgical complications, and possibly functional impairment. Therefore, stakeholders including patients, surgeons, employers, and administrators will benefit from evidence-based guidelines for implant removal following operatively treated Lisfranc injuries. To date, there has not been a prospective randomized study evaluating the efficacy of implant removal compared with implant retention for Lisfranc injuries. The aim of this study is to directly compare patient-reported and radiographic outcomes, in order to provide robust evidence for optimal post-operative treatment regimens regarding implant removal or retention for operatively treated Lisfranc injuries.
Detailed Description
This study is a multicenter, randomized clinical trial comparing implant retention (Retention Group) to scheduled implant removal (Removal Group) in 100 skeletally mature patients with Lisfranc injuries previously treated with screw and/or plate fixation. The primary outcome measure is the validated, patient-reported Foot and Ankle Ability Measure (FAAM) at 1-year post initial Lisfranc injury. Secondary outcome measures include: 1. American Orthopedics Foot and Ankle Midfoot Score (AOFAS), 2. patient-reported Visual Analogue Scale (VAS) for Foot and Ankle, 3. range of motion, 4. radiographic assessment of Lisfranc reduction, 5. comparative cost analysis between treatment groups. This study will follow patients for 1-year post-injury. Patients, surgeons, employers, and administrators will benefit from an evidence-based approach to implant removal following operatively treated Lisfranc injuries. This study will allow orthopaedic surgeons to counsel patients regarding the advantages and disadvantages of implant retention compared with removal. This study will provide robust data to inform clinical decision making for surgeons and provide patients with information regarding expected functional outcomes following Lisfranc injuries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lisfranc Injuries
Keywords
Lisfranc

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a multicenter randomized clinical trial comparing implant retention (Retention) to scheduled removal of implants (Removal) in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Removal Group
Arm Type
Active Comparator
Arm Description
The implant removal group will have surgery scheduled 6 months after their initial surgical fixation.
Arm Title
Retention Group
Arm Type
No Intervention
Arm Description
The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery.
Intervention Type
Procedure
Intervention Name(s)
Implant removal
Intervention Description
Surgical Implant removal
Primary Outcome Measure Information:
Title
Foot and Ankle Ability Measure (FAAM)
Description
FAAM is a patient-reported outcome tool used to assess physical function at 24 months post initial Lisfranc surgery. This instrument includes 2 sub-scales: activities of daily living sub scale of 21 items and sport sub scale of 8 items. Answers for both scales are based on a Likert scale (4-0) of: 4) No difficulty, 3) Slight difficulty, 2) Moderate difficulty, 1) Extreme difficulty, and 0) Unable to do. Questions for which "N/A" is indicated are not counted. Two scores are reported, one for each sub scale. To calculate the score for either sub scale, the total number of points are added, divided by the number of possible points (84 for ADL and 32 for sports), and multiplied by 100. Higher scores reflect a higher level of physical function.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
American Orthopedics Foot and Ankle Midfoot Score (AOFAS)
Description
AOFAS is a surgeon-administered questionnaire, used for assessment of pain, function and alignment. The total score is reported. Scores range from 0 to 100, with a healthy midfoot receiving 100 points
Time Frame
24 months
Title
Patient-reported Visual Analogue Scale (VAS) for Foot and Ankle
Description
VAS for Foot and Ankle is a validated tool for assessing pain intensity specific to foot injuries. The patient is asked to mark their current situation on a 10 cm line with anchor statements on the left (negative outcome) and on the right (positive outcome). Longer distances (from the "negative outcome" anchor point) represent a better outcome.
Time Frame
24 months
Title
Range of motion (ROM)
Description
Assessed buy surgeon
Time Frame
24 months
Title
Radiographic assessment of Lisfranc reduction
Description
Maintenance of reduction and degree of arthritic changes across Lisfranc complex (gap between 1st and 2nd metatarsals, between the lateral aspect of the medial cuneiform to the medial aspect of second metatarsal) will be assessed by comparison of index Xrays upon enrollment and follow-up X-rays.
Time Frame
24 months
Title
Comparative cost analysis between treatment groups
Description
Comparative cost of treatment and any complications plus incremental costs up to 2-year follow-up will be collected and compared between groups.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older and skeletally mature Subject has Lisfranc injury that was previously treated with screws and/or plate fixation within 21 days of initial injury Subject must be enrolled in study within 6 weeks (+/-2 weeks) from time of initial fixation operation The patient must be medically fit for anaesthesia 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 Exclusion Criteria: Subject has a significant pre-existing foot injury or deformity There has been loss of fixation or reduction prior to enrollment Subject was treated with a primary tarsometatarsal joint fusion Subject has a delay in initial treatment greater than 21 days from time of injury Subject has an active infection in the area of surgical approach Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time Subject has a history of rheumatoid arthritis, Diabetes, metabolic bone disease (including osteoporosis actively being treated), active malignancy, pathologic fracture or 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 Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires Subject is pregnant or planning on becoming pregnant in the following year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prism Schneider, MD,PhD,FRCS(C)
Phone
403-944-4518
Email
prism.schneider@gmail.com
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prism Schneider, MD,PhD,FRCS(C)

12. IPD Sharing Statement

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Fixation In-situ vs Removal for Midfoot Lisfranc Injuries

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