Fixation In-situ vs Removal for Midfoot Lisfranc Injuries

NCT03694288 | Unknown

• 1 other identifier: FIRM Protocol
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lisfranc Injuries

Keywords

Lisfranc

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (5)

• American Orthopedics Foot and Ankle Midfoot Score (AOFAS)

  24 months

• Patient-reported Visual Analogue Scale (VAS) for Foot and Ankle

  24 months

• Range of motion (ROM)

  24 months

• Radiographic assessment of Lisfranc reduction

  24 months

• Comparative cost analysis between treatment groups

  24 months

Study Arms (2)

Removal Group

ACTIVE COMPARATOR

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

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.

Interventions

Implant removal PROCEDURE

Surgical Implant removal

Removal Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Memorial University of Newfoundland: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Interventions

Device Removal

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Prism Schneider, MD,PhD,FRCS(C)

CONTACT

403-944-4518; prism.schneider@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Trauma Research Lead

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: September 7, 2017
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

CA (1)