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

University of Calgary

Status

Enrolling

Conditions

Lisfranc Injuries

Treatments

Procedure: Implant removal

Study type

Interventional

Funder types

Other

Identifiers

NCT03694288

FIRM Protocol

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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