Stability and Outcomes of Non-displaced Lisfranc Injuries

NCT ID: NCT04430101

Last Updated: 2023-05-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2029-12-31

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.

Conditions

Lisfranc Injury; Sprain of Foot

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Negative WB radiographs and stress fluoroscopy

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

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: PROCEDURE

Patients with negative weightbearing radiographs will be treated conservatively

Negative WB radiographs / positive stress fluoroscopy

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

Group Type: ACTIVE_COMPARATOR

Conservative treatment

Intervention Type: PROCEDURE

Patients with negative weightbearing radiographs will be treated conservatively

Surgical cohort (Cohort 3)

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

Group Type: OTHER

Minimally invasive stabilization of Lisfranc injuries

Intervention Type: PROCEDURE

Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)

Interventions

Minimally invasive stabilization of Lisfranc injuries

Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)

Intervention Type: PROCEDURE

Conservative treatment

Patients with negative weightbearing radiographs will be treated conservatively

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Ostfold Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marius Molund, MD

Role: PRINCIPAL_INVESTIGATOR

Ostfold Hospital Trust

Locations

Oslo university hospial

Oslo, , Norway

Østfold Hospital Trust

Sarpsborg, Østfold fylke, Norway

Countries

Norway

Other Identifiers

20/00913

Identifier Type: -

Identifier Source: org_study_id