Recruiting

Fixation vs. Removal

Sponsor:

University of Calgary

Code:

NCT02374944

Conditions

Closed Fracture Dislocation, Tarsometatarsal Joint

Open Fracture Dislocation, Tarsometatarsal Joint

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hardware removal

Study Details

Brief summary:

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

Conditions

Closed Fracture Dislocation, Tarsometatarsal Joint

Open Fracture Dislocation, Tarsometatarsal Joint

Study ID

NCT02374944

Start date

Jan 23, 2018

Status verified date

Nov, 2022

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hardware Removal

Removal of hardware at 6 months.

no intervention: Hardware Retention

Retention of hardware at 6 months

Interventions

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.

Primary outcome 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 ]

Central Contacts and Locations

Central contacts

Karin Lienhard, PhD

403-944-2932karin.lienhard@ucalgary.ca

Locations

Foothills Medical Centre

Recruiting

Calgary, Alberta, Canada

Contacts

Karin Lienhard, PhD

4039444594karin.lienhard@ucalgary.ca

Principal Investigator:

Paul Duffy, MD

More Information

Sponsor

University of Calgary

Last update posted

Nov 9, 2022

Last verified

Nov, 2022

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 2022-11-09.