Recruiting

Implant Removal vs. RetentionFixation In-situ vs Removal for Midfoot Lisfranc Injuries

Sponsor:

University of Calgary

Code:

NCT03694288

Conditions

Lisfranc Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Implant removal

Study Details

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

Study ID

NCT03694288

Start date

Sep 7, 2017

Status verified date

Jul, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Removal Group

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

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.

Interventions

Implant removal

Surgical Implant removal

Primary outcome measure

Foot and Ankle Ability Measure (FAAM) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Prism Schneider, MD,PhD,FRCS(C)

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

Locations

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 1N4

More Information

Sponsor

University of Calgary

Last update posted

Jul 11, 2022

Last verified

Jul, 2022

Keywords

Lisfranc

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-07-11.