Clinical trial NCT04430101: Stability and Outcomes of Non-displaced Lisfranc Injuries
Official title: Stability and Outcomes of Non-displaced Lisfranc Injuries - A Prospective Multicenter Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lisfranc Injury
Sprain of Foot
Keywords: Lisfranc injury
Weightbearing radiographs
Stress fluoroscopy
Homerun screw
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2020-06-12
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are evaluated by weightbearing radiographs. Patients with no signs of dislocation on the weightbearing radiographs will undergo stress fluoroscopy. Patients with negative stress fluoroscopy are allocated to Cohort 1, patients with positive stress fluoroscopy are allocated to Cohort 2.

The study design is a non-inferiority study, proving to show that the outcomes of Cohort 2 are non-inferior compared to Cohort 1.

Patients with positive weightbearing radiographs (interval between medial cuneiform and base of second metatarsal increased by \> 2 mm compared to the contralateral side) will be operated with minimally invasive stabilization (eg. isolated "homerun screw") and followed up prospectively as a single cohort (Cohort 3).
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Manchester-Oxford Foot Questionnaire (MOxFQ)
timeFrame: 5 years
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
timeFrame: 5 years
measure: Self-reported foot and ankle score (SEFAS)
timeFrame: 5 years
measure: Visual Analogue Scale (VAS) for pain
timeFrame: 5 years
measure: Short-Form (SF) 36
timeFrame: 5 years
measure: Posttraumatic osteoarthritis
timeFrame: 5 years
measure: Incidence of complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospial
city: Sarpsborg
country: Norway
facility: Østfold Hospital Trust
state: Østfold
Study officials:
affiliation: Ostfold Hospital Trust
name: Marius Molund, MD
role: PRINCIPAL_INVESTIGATOR
References: