Clinical trial NCT02374944: Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Official title: A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Closed Fracture Dislocation, Tarsometatarsal Joint
Open Fracture Dislocation, Tarsometatarsal Joint
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Calgary Orthopaedic Research and Education Fund
name: Memorial University of Newfoundland
First posted: 2015-03-02
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
timeFrame: 6 weeks
measure: AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
timeFrame: 12 weeks
measure: AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
timeFrame: 6 months
measure: AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
timeFrame: 1 year
measure: AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
timeFrame: 2 years
measure: VAS-FA - Visual Analog Scale Foot and Ankle
timeFrame: 6 weeks
measure: VAS-FA - Visual Analog Scale Foot and Ankle
timeFrame: 12 weeks
measure: VAS-FA - Visual Analog Scale Foot and Ankle
timeFrame: 6 months
measure: VAS-FA - Visual Analog Scale Foot and Ankle
timeFrame: 1 year
measure: VAS-FA - Visual Analog Scale Foot and Ankle
timeFrame: 2 years
measure: SF-36
timeFrame: 6 weeks
measure: SF-36
timeFrame: 12 weeks
measure: SF-36
timeFrame: 6 months
measure: SF-36
timeFrame: 1 year
measure: SF-36
timeFrame: 2 years
measure: VAS - Visual Analogue Scale (Patient Satisfaction)
timeFrame: 6 weeks
measure: VAS - Visual Analogue Scale (Patient Satisfaction)
timeFrame: 12 weeks
measure: VAS - Visual Analogue Scale (Patient Satisfaction)
timeFrame: 6 months
measure: VAS - Visual Analogue Scale (Patient Satisfaction)
timeFrame: 1 year
measure: VAS - Visual Analogue Scale (Patient Satisfaction)
timeFrame: 2 years
Secondary outcomes:
measure: Radiologic outcome
timeFrame: 2 years
measure: Cost-effectiveness
timeFrame: 2 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: University of Calgary
name: Paul J Duffy, MD
role: PRINCIPAL_INVESTIGATOR
References: