Stability and Outcomes of Non-displaced Lisfranc Injuries

Ostfold Hospital Trust

Status: Active, not recruiting

Conditions: Lisfranc Injury; Sprain of Foot

Treatments: Procedure: Minimally invasive stabilization of Lisfranc injuries; Procedure: Conservative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04430101

20/00913

Details and patient eligibility

About

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

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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131 participants in 3 patient groups

Negative WB radiographs and stress fluoroscopy

Active Comparator group

Description:

Cohort 1 Negative weight bearing radiographs: Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side. Negative stress fluoroscopy: the midfoot is tested stable

Treatment:

Procedure: Conservative treatment

Negative WB radiographs / positive stress fluoroscopy

Active Comparator group

Description:

Cohort 2 Negative weight bearing radiographs: Interval between medial cuneiform and base of the second metatarsal (C1-M2) are less than 2mm increased compared to the uninjured side. Positive stress fluoroscopy: manual testing reveals midfoot instability

Treatment:

Procedure: Conservative treatment

Surgical cohort (Cohort 3)

Other group

Description:

Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort.

Treatment:

Procedure: Minimally invasive stabilization of Lisfranc injuries