Hardware removal for Tarsometatarsal Joint Dislocation/Fracture

Foothills Medical Centre, Calgary, Canada
Tarsometatarsal Joint Dislocation/Fracture+1 More ConditionsHardware removal - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is comparing two ways of treating people who have had surgery to fix a broken bone in their leg. The first group will have metal rods and screws put in to hold the bone in place (hardware retention). The second group will have the metal rods and screws taken out after the bone has healed (removal of hardware).

Eligible Conditions
  • Tarsometatarsal Joint Dislocation/Fracture
  • Tarsometatarsal Joint Fracture Dislocation

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

4 Primary · 2 Secondary · Reporting Duration: 2 years

2 years
AOFAS - American Orthopaedic Foot and Ankle Society Midfoot Score
Cost-effectiveness
Radiologic outcome
SF-36
VAS - Visual Analogue Scale (Patient Satisfaction)
Ankle

Trial Safety

Phase-Based Safety

1 of 3

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1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Hardware Retention
1 of 2
Hardware Removal
1 of 2

Active Control

Experimental Treatment

94 Total Participants · 2 Treatment Groups

Primary Treatment: Hardware removal · No Placebo Group · N/A

Hardware Removal
Procedure
Experimental Group · 1 Intervention: Hardware removal · Intervention Types: Procedure
Hardware RetentionNoIntervention Group · 1 Intervention: Hardware Retention · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

University of CalgaryLead Sponsor
729 Previous Clinical Trials
573,664 Total Patients Enrolled
Memorial University of NewfoundlandOTHER
62 Previous Clinical Trials
1,764,061 Total Patients Enrolled
Calgary Orthopaedic Research and Education FundOTHER
3 Previous Clinical Trials
436 Total Patients Enrolled
Paul J Duffy, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You may have other injuries as long as they will not affect your recovery process, according to the surgeon's judgment.
You may have an injury in your foot called a Lisfranc injury that affects your bones or ligaments.
You have metal implants in the middle of your foot (joints between your tarsal and metatarsal bones).
You had a Lisfranc injury that was treated less than a month ago.
References

Frequently Asked Questions

What is the scale of enrolment for this trial?

"Affirmative. Clinicaltrials.gov has the latest information regarding this medical evaluation, which was first posted on January 23rd 2018 and updated as recently as November 4th 2022. 94 individuals are being recruited from one site to participate in this study." - Anonymous Online Contributor

Unverified Answer

Does this trial have open enrollment at present?

"Per the information published on clinicaltrials.gov, this medical investigation is actively looking for eligible participants. The trial was initially posted in January of 2018 and has been renewed as recently as November 4th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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