Fixation In-situ vs Removal for Midfoot Lisfranc Injuries

NCT ID: NCT03694288

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Lisfranc Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Removal Group

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

Group Type: ACTIVE_COMPARATOR

Implant removal

Intervention Type: PROCEDURE

Surgical Implant removal

Retention Group

The implant retention group will retain their implant for a minimum of 2 years from the time of their initial surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implant removal

Surgical Implant removal

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial University of Newfoundland

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Prism Schneider

Orthopaedic Trauma Research Lead

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Prism Schneider, MD,PhD,FRCS(C)

Role: CONTACT

prism.schneider@gmail.com

403-944-4518

Facility Contacts

Prism Schneider, MD,PhD,FRCS(C)

Role: primary

Other Identifiers

FIRM Protocol

Identifier Type: -

Identifier Source: org_study_id