Lisfranc InjuriesFIRMNCT03694288
Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
A study testing Implant removal in people with Lisfranc Injuries, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lisfranc Injuries
- What is being tested?
- Implant removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2017to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Prism Schneider, MD,PhD,FRCS(C)
About this study
Official title: The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
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.
Read the 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.
- Conditions
- Lisfranc Injuries
- Being tested
- Implant removal
- Keywords
- Lisfranc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant removalProcedure or surgery
Surgical Implant removal
| Study group | Role | What they receive |
|---|---|---|
| Removal Group | Active comparator | The implant removal group will have surgery scheduled 6 months after their initial surgical fixation. Receives: Procedure: Implant removal |
| Retention Group | No intervention | The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (5)
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
Measured: 24 months
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.
Measured: 24 months
Range of motion (ROM)
Assessed buy surgeon
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start7 Sep 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lisfranc InjuriesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial University of Newfoundland
- Responsible party
- Principal investigator, Prism Schneider, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694288
- Sponsor's protocol ID
- FIRM Protocol
- Acronym
- FIRM
- Status last verified
- Jul 2022
- First submitted
- 1 Oct 2018
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
- ClinicalTrials.gov ID
- NCT03694288
- Acronym / sponsor ID
- FIRM / FIRM Protocol
- Conditions
- Lisfranc Injuries
- Keywords
- Lisfranc
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Memorial University of Newfoundland
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Oct 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Removal Group | Active comparator | Procedure: Implant removalThe implant removal group will have surgery scheduled 6 months after their initial surgical fixation. |
| Retention Group | No intervention | –The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Implant removalSurgical Implant removal | Procedure or surgery | Removal Group |
Primary outcome
Foot and Ankle Ability Measure (FAAM)
Time frame: 24 months
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.
5 secondary outcomes
American Orthopedics Foot and Ankle Midfoot Score (AOFAS)
Time frame: 24 months
Patient-reported Visual Analogue Scale (VAS) for Foot and Ankle
Time frame: 24 months
Range of motion (ROM)
Time frame: 24 months
Radiographic assessment of Lisfranc reduction
Time frame: 24 months
Comparative cost analysis between treatment groups
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
Related trials for Lisfranc Injuries
Recruiting
Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation
Medial Malleolus Fracture, Lisfranc Injury
Active, not recruiting
Stability and Outcomes of Non-displaced Lisfranc Injuries
Lisfranc Injury, Sprain of Foot
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant removal in people with Lisfranc Injuries, run by University of Calgary at 1 site in Canada.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2022. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prism Schneider, MD,PhD,FRCS(C) (403-944-4518, prism.schneider@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Foot and Ankle Ability Measure (FAAM) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2022.