Closed Fracture Dislocation, Tarsometatarsal JointFIRMNCT02374944
Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
A study testing Hardware removal in people with Closed Fracture Dislocation, Tarsometatarsal Joint and Open Fracture Dislocation, Tarsometatarsal Joint, run by University of Calgary at 3 sites in Canada.
Trial summary
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint
- What is being tested?
- Hardware removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 3 sitesCanada
- Study dates
- 23 Jan 2018to Dec 2025
- 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
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 1 recruiting
- Recruiting
Foothills Medical Centre
Calgary, Alberta
Karin Lienhard, PhD, 4039444594, karin.lienhard@ucalgary.ca
Paul Duffy, MD
- Active, not recruiting
Peter Lougheed Centre
Calgary, Alberta
- Active, not recruiting
South Health Campus
Calgary, Alberta
About this study
Official title: A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).
Read the 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.
- Conditions
- Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint
- Being tested
- Hardware removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hardware removalProcedure or surgery
Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.
| Study group | Role | What they receive |
|---|---|---|
| Hardware Removal | Experimental | Removal of hardware at 6 months. Receives: Procedure: Hardware removal |
| Hardware Retention | No intervention | Retention of hardware at 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: 6 months
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.
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 6 weeks
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.
Measured: 12 weeks
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.
Measured: 6 months
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.
Measured: 1 year
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.
Measured: 2 years
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Measured: 6 weeks
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Measured: 12 weeks
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Measured: 6 months
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Measured: 1 year
SF-36
Patient reported measure on physical and mental status on 36 items across eight health domains.
Measured: 2 years
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Measured: 6 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Measured: 12 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Measured: 6 months
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Measured: 1 year
VAS - Visual Analogue Scale (Patient Satisfaction)
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
Measured: 2 years
Secondary outcomes (2)
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.
Measured: 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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study start23 Jan 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Fracture Dislocation, Tarsometatarsal JointStudies 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
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Calgary Orthopaedic Research and Education Fund, Memorial University of Newfoundland
- Responsible party
- Principal investigator, Paul Duffy, University of Calgary
- Investigators
- Paul J Duffy, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374944
- Sponsor's protocol ID
- REB14-0625
- Acronym
- FIRM
- Status last verified
- Nov 2022
- First submitted
- 10 Feb 2015
- Last updated
- 9 Nov 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
- ClinicalTrials.gov ID
- NCT02374944
- Acronym / sponsor ID
- FIRM / REB14-0625
- Conditions
- Closed Fracture Dislocation, Tarsometatarsal Joint, Open Fracture Dislocation, Tarsometatarsal Joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Calgary Orthopaedic Research and Education Fund, Memorial University of Newfoundland
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Mar 2015 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hardware Removal | Experimental | Procedure: Hardware removalRemoval of hardware at 6 months. |
| Hardware Retention | No intervention | –Retention of hardware at 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Hardware removalComparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation. | Procedure or surgery | Hardware Removal |
Primary outcome
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Time frame: 6 weeks
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
Time frame: 12 weeks
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
Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 2 years
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
Time frame: 6 weeks
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
Time frame: 12 weeks
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
Time frame: 6 months
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
Time frame: 1 year
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
Time frame: 2 years
Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.
SF-36
Time frame: 6 weeks
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Time frame: 12 weeks
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Time frame: 6 months
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Time frame: 1 year
Patient reported measure on physical and mental status on 36 items across eight health domains.
SF-36
Time frame: 2 years
Patient reported measure on physical and mental status on 36 items across eight health domains.
VAS - Visual Analogue Scale (Patient Satisfaction)
Time frame: 6 weeks
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Time frame: 12 weeks
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Time frame: 6 months
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Time frame: 1 year
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
VAS - Visual Analogue Scale (Patient Satisfaction)
Time frame: 2 years
Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.
2 secondary outcomes
Radiologic outcome
Time frame: 2 years
Cost-effectiveness
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
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.
Paul J Duffy, MD principal investigator
University of Calgary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hardware removal in people with Closed Fracture Dislocation, Tarsometatarsal Joint and Open Fracture Dislocation, Tarsometatarsal Joint, run by University of Calgary at 3 sites 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 10 inclusion and 14 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Karin Lienhard, PhD (403-944-2932, karin.lienhard@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score (time frame: 6 weeks). The study lists 20 primary outcomes in all. 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 9 Nov 2022.