NCT04430101

Stability and Outcomes of Non-displaced Lisfranc Injuries

Stability and Outcomes of Non-displaced Lisfranc Injuries - A Prospective Multicenter Cohort Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Ostfold Hospital Trust · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive stabilization of Lisfranc injuries	Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)
PROCEDURE	Conservative treatment	Patients with negative weightbearing radiographs will be treated conservatively

Timeline

• Start date: 2020-06-09
• Primary completion: 2028-12-31
• Completion: 2029-12-31
• First posted: 2020-06-12
• Last updated: 2023-05-01

Locations

2 sites across 1 country: Norway