Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries (FIRM)

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).

Study Overview

• Status: Recruiting
• Conditions: Closed Fracture Dislocation, Tarsometatarsal Joint; Open Fracture Dislocation, Tarsometatarsal Joint
• Intervention / Treatment: Procedure: Hardware removal

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 Type: Interventional
• Enrollment (Anticipated): 94
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karin Lienhard, PhD; Phone Number: 403-944-2932; Email: karin.lienhard@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • Foothills Medical Centre
      • Contact: Karin Lienhard, PhD; Phone Number: 4039444594; Email: karin.lienhard@ucalgary.ca
      • Principal Investigator: Paul Duffy, MD
      • Sub-Investigator: Robert Korley, MD
      • Sub-Investigator: Christopher R Martin, MD
      • Sub-Investigator: Richard Buckley, MD
      • Sub-Investigator: Prism Schneider, MD
    • Calgary, Alberta, Canada
      • Active, not recruiting
      • Peter Lougheed Centre
    • Calgary, Alberta, Canada
      • Active, not recruiting
      • South Health Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hardware Removal; Removal of hardware at 6 months.	Procedure: Hardware removal; Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.
No Intervention: Hardware Retention; Retention of hardware at 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	2 years
SF-36	Patient reported measure on physical and mental status on 36 items across eight health domains.	6 weeks
SF-36	Patient reported measure on physical and mental status on 36 items across eight health domains.	12 weeks
SF-36	Patient reported measure on physical and mental status on 36 items across eight health domains.	6 months
SF-36	Patient reported measure on physical and mental status on 36 items across eight health domains.	1 year
SF-36	Patient reported measure on physical and mental status on 36 items across eight health domains.	2 years
VAS - Visual Analogue Scale (Patient Satisfaction)	Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.	6 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)	Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.	12 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)	Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.	6 months
VAS - Visual Analogue Scale (Patient Satisfaction)	Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.	1 year
VAS - Visual Analogue Scale (Patient Satisfaction)	Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	2 years

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Memorial University of Newfoundland; Calgary Orthopaedic Research and Education Fund
• Investigators: Principal Investigator: Paul J Duffy, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Fractures, Bone; Joint Dislocations; Fractures, Closed; Fractures, Open; Fracture Dislocation
• Other Study ID Numbers: REB14-0625

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No