Stability and Outcomes of Non-displaced Lisfranc Injuries

  • STATUS
    Recruiting
  • End date
    Dec 31, 2029
  • participants needed
    90
  • sponsor
    Ostfold Hospital Trust
Updated on 19 February 2024

Summary

In this multicenter cohort study, the stability of non-displaced Lisfranc injuries as well as their outcomes will be evaluated.

Description

Injuries to the tarsometatarsal joints ("Lisfranc injuries") that are non-displaced on non-weightbearing radiographs and CT are common injuries. To refer these injuries to the right treatment, evaluating their stability is essential. For this purpose, both weightbearing radiographs and stress fluoroscopy have been proposed. However, there is no consensus concerning both the use and interpretation of weightbearing radiographs and no standardized technique and interpretation of stress fluoroscopy in non-displaced Lisfranc injuries.

In the current study, participants will be assigned to non-operative or operative treatment based on Lisfranc joint stability evaluation by weightbearing radiographs.

All Patients with negative weightbearing radiographs will be treated conservatively. In addition, their injured feet will be evaluated by manual stress fluoroscopy. Depending on the result of the stress fluoroscopy (positive/negative), the conservatively treated patients will be assigned to 2 cohorts, whose outcomes will be compared.

Patients with positive weightbearing radiographs will be treated operatively by minimally invasive stabilization of the midfoot (eg. isolated "homerun screw"). The operatively treated patients will be followed up as an independent cohort.

Details
Condition Lisfranc Injury, Sprain of Foot
Age 18-70 years
Treatment Minimally invasive stabilization of Lisfranc injuries, Conservative treatment
Clinical Study IdentifierNCT04430101
SponsorOstfold Hospital Trust
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Acute Lisfranc injuries that are non-displaced (< 2mm) on non-weightbearing radiographs and CT
Patients between 18 and 70 years of age
Acute presentation at one of our departments, enabling evaluating the stability of the injuries within 4 weeks

Exclusion Criteria

Fractures with an intraarticular step of > 2mm on the initial non weight-bearing radiographs and/or CT
Delayed presentation (weight-bearing radiographs taken > 4 weeks after injury)
Bilateral injuries
Concomitant major injuries of the foot, ankle or leg that affect the rehabilitation process
Multitraumized patients
Previous injury or surgery of the mid foot
Charcot foot
Noncompliant patients
Insufficient Norwegian or English language skills
Patients not available for follow-up
Inability to conduct the rehabilitation protocol
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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