Overview

This trial is active, not recruiting.

Conditions closed fracture dislocation, tarsometatarsal joint, open fracture dislocation, tarsometatarsal joint
Treatment hardware removal
Sponsor University of Calgary
Collaborator Calgary Orthopaedic Research and Education Fund
Start date November 2015
End date December 2020
Trial size 94 participants
Trial identifier NCT02374944, REB14-0625

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Removal of hardware at 6 months.
hardware removal
(No Intervention)
Retention of hardware at 6 months

Primary Outcomes

Measure
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
time frame: 6 weeks
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
time frame: 12 weeks
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
time frame: 6 months
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
time frame: 1 year
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
time frame: 2 years
VAS-FA - Visual Analog Scale Foot and Ankle
time frame: 6 weeks
VAS-FA - Visual Analog Scale Foot and Ankle
time frame: 12 weeks
VAS-FA - Visual Analog Scale Foot and Ankle
time frame: 6 months
VAS-FA - Visual Analog Scale Foot and Ankle
time frame: 1 year
VAS-FA - Visual Analog Scale Foot and Ankle
time frame: 2 years
SF-36
time frame: 6 weeks
SF-36
time frame: 12 weeks
SF-36
time frame: 6 months
SF-36
time frame: 1 year
SF-36
time frame: 2 years
VAS - Visual Analogue Scale (Patient Satisfaction)
time frame: 6 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)
time frame: 12 weeks
VAS - Visual Analogue Scale (Patient Satisfaction)
time frame: 6 months
VAS - Visual Analogue Scale (Patient Satisfaction)
time frame: 1 year
VAS - Visual Analogue Scale (Patient Satisfaction)
time frame: 2 years

Secondary Outcomes

Measure
Radiologic outcome
time frame: 2 years
Cost-effectiveness
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Principal investigator Paul J Duffy, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Calgary.