NCT02374944

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 2, 2015

Completed
2.9 years until next milestone

Study Start

First participant enrolled

January 23, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

6.9 years

First QC Date

February 10, 2015

Last Update Submit

November 4, 2022

Conditions

Closed Fracture Dislocation, Tarsometatarsal JointOpen Fracture Dislocation, Tarsometatarsal Joint

Outcome Measures

Primary Outcomes (20)

  • AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score

    Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.

    6 weeks

  • AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score

    Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.

    12 weeks

  • AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score

    Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.

    6 months

  • AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score

    Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.

    1 year

  • AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score

    Subjective and objective evaluation of the midfoot with breakdown by function (45 points), pain (40 points), and alignment (15 points) with a yield anywhere between 0 and 100 points where 100 points is a perfect score.

    2 years

  • VAS-FA - Visual Analog Scale Foot and Ankle

    Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.

    6 weeks

  • VAS-FA - Visual Analog Scale Foot and Ankle

    Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.

    12 weeks

  • VAS-FA - Visual Analog Scale Foot and Ankle

    Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.

    6 months

  • VAS-FA - Visual Analog Scale Foot and Ankle

    Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.

    1 year

  • VAS-FA - Visual Analog Scale Foot and Ankle

    Patient reported responses on 20 subjective questions (Pain - 4; functional deficits -13; other complaints - 3) equally weighted. Possible score out of 100.

    2 years

  • SF-36

    Patient reported measure on physical and mental status on 36 items across eight health domains.

    6 weeks

  • SF-36

    Patient reported measure on physical and mental status on 36 items across eight health domains.

    12 weeks

  • SF-36

    Patient reported measure on physical and mental status on 36 items across eight health domains.

    6 months

  • SF-36

    Patient reported measure on physical and mental status on 36 items across eight health domains.

    1 year

  • SF-36

    Patient reported measure on physical and mental status on 36 items across eight health domains.

    2 years

  • VAS - Visual Analogue Scale (Patient Satisfaction)

    Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.

    6 weeks

  • VAS - Visual Analogue Scale (Patient Satisfaction)

    Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.

    12 weeks

  • VAS - Visual Analogue Scale (Patient Satisfaction)

    Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.

    6 months

  • VAS - Visual Analogue Scale (Patient Satisfaction)

    Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.

    1 year

  • VAS - Visual Analogue Scale (Patient Satisfaction)

    Single visual analogue scale to evaluate patient satisfaction on a scale of 0 to 100.

    2 years

Secondary Outcomes (2)

  • Radiologic outcome

    2 years

  • Cost-effectiveness

    2 years

Study Arms (2)

Hardware Removal

EXPERIMENTAL

Removal of hardware at 6 months.

Procedure: Hardware removal

Hardware Retention

NO INTERVENTION

Retention of hardware at 6 months

Interventions

Hardware removalPROCEDURE

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 Removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Foothills Medical Centre

Calgary, Alberta, Canada

RECRUITING

Peter Lougheed Centre

Calgary, Alberta, Canada

ACTIVE NOT RECRUITING

South Health Campus

Calgary, Alberta, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Hardware Removal

Intervention Hierarchy (Ancestors)

Device RemovalSurgical Procedures, Operative

Study Officials

  • Paul J Duffy, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Lienhard, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division Head, Orthopaedic Trauma

Study Record Dates

First Submitted

February 10, 2015

First Posted

March 2, 2015

Study Start

January 23, 2018

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

CA(3)