Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694288
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Memorial University of Newfoundland
Information provided by (Responsible Party):
Prism Schneider, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Lisfranc Injuries Procedure: Implant removal Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: The FIRM Trial - A Randomized Clinical Trial Evaluating Fixation In-situ vs Removal for Midfoot Lisfranc Injuries
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Active Comparator: Removal Group
The implant removal group will have surgery scheduled 6 months after their initial surgical fixation.
Procedure: Implant removal
Surgical Implant removal

No Intervention: Retention Group
The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. American Orthopedics Foot and Ankle Midfoot Score (AOFAS) [ Time Frame: 24 months ]
    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

  2. Patient-reported Visual Analogue Scale (VAS) for Foot and Ankle [ Time Frame: 24 months ]
    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.

  3. Range of motion (ROM) [ Time Frame: 24 months ]
    Assessed buy surgeon

  4. Radiographic assessment of Lisfranc reduction [ Time Frame: 24 months ]
    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.

  5. Comparative cost analysis between treatment groups [ Time Frame: 24 months ]
    Comparative cost of treatment and any complications plus incremental costs up to 2-year follow-up will be collected and compared between groups.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694288


Contacts
Layout table for location contacts
Contact: Prism Schneider, MD,PhD,FRCS(C) 403-944-4518 prism.schneider@gmail.com

Locations
Layout table for location information
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Prism Schneider, MD,PhD,FRCS(C)         
Sponsors and Collaborators
University of Calgary
Memorial University of Newfoundland
Layout table for additonal information
Responsible Party: Prism Schneider, Orthopaedic Trauma Research Lead, University of Calgary
ClinicalTrials.gov Identifier: NCT03694288    
Other Study ID Numbers: FIRM Protocol
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prism Schneider, University of Calgary:
Lisfranc
Additional relevant MeSH terms:
Layout table for MeSH terms
Wounds and Injuries