Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-23

Study Completion Date

2025-12-31

Brief Summary

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This study is a multicenter prospective randomized control trial comparing hardware retention (HR) to removal of hardware (RH).

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Detailed Description

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Eligible patients will be randomized to one of two treatment arms: Hardware removal at 6 months or Hardware retention for a minimum of 2 years.

Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms: removal hardware (RH) or hardware retention (HR).

Outcome will be assessed at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years from enrollment.

Conditions

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Closed Fracture Dislocation, Tarsometatarsal Joint Open Fracture Dislocation, Tarsometatarsal Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hardware Removal

Removal of hardware at 6 months.

Group Type EXPERIMENTAL

Hardware removal

Intervention Type PROCEDURE

Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.

Hardware Retention

Retention of hardware at 6 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hardware removal

Comparison of implant retention vs. scheduled implant removal in skeletally mature patients with previously operatively treated Lisfranc injuries requiring screw and/or plate fixation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Subject has Lisfranc injury that was treated within 28 days of injury.
* Subject must be enrolled in study between 6 and 8 weeks from time of initial fixation operation.
* The patient must be medically fit for anesthesia
* 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
* Subject may have a bony, ligamentous, or combined lisfranc injury
* Demonstrated instability of the lisfranc complex on static, stress view or CT radiography.
* Associated injuries - other than the lisfranc complex - are permitted provided those injuries are not deemed to significantly influence the rehabilitation or recovery of the patient at the discretion of the enrolling surgeon
* Adequate reduction to within 1mm of lisfranc complex at time of fixation
* Hardware across the midfoot (tarsal-metatarsal joints 1-3)

Exclusion Criteria

* Subject has a significant pre-existing foot injury
* Subject has a delay in initial treatment greater than 28 days from time of injury
* Subject has an active infection in the area of surgical approach requiring surgical debridement
* Subject has concomitant injury which, in the opinion of the attending surgeon, is likely to impair rehabilitation or prolong fracture healing time (another long bone fracture, ipsilateral limb injury)
* Subject has a history of rheumatoid arthritis, Diabetes, fibrous dysplasia, chronic renal failure, Paget's disease, or osteopetrosis or any 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(no fixed address, plans to move out of town in the next year, states unable to comply with protocol, etc.)
* Subject has cognitive impairment or language difficulties that would impede the valid completion of questionnaires
* Subject is pregnant
* There has been loss of fixation or reduction prior to enrollment
* Previous corrective foot surgery
* Associated fracture of calcaneus, talus, or tibial plafond.
* Pathologic fracture
* Loss of fixation or reduction prior to enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No