Stability and Outcomes of Non-displaced Lisfranc Injuries

Lisfranc Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04430101
• Other study ID #: 20/00913
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: December 31, 2029

Study information

• Verified date: April 2023
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lisfranc Injury
• Sprain of Foot
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo university hospial	Oslo
Norway	Østfold Hospital Trust	Sarpsborg	Østfold

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manchester-Oxford Foot Questionnaire (MOxFQ)	Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)	5 years
Secondary	American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score	Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)	5 years
Secondary	Self-reported foot and ankle score (SEFAS)	Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)	5 years
Secondary	Visual Analogue Scale (VAS) for pain	Scores pain at rest and on activity (0-10 with 0 representing no pain)	5 years
Secondary	Short-Form (SF) 36	Patient reported score measuring quality of life and health status	5 years
Secondary	Posttraumatic osteoarthritis	The presence of osteoarthritis of the tarsometatarsal joints is graded based on the Brodén radiographs taken at 1 year, 2 year and 5 year follow-up using the Kellgren & Lawrence classification system.	5 years
Secondary	Incidence of complications	Yes/no for deep or superficial infection, nerve or tendon injury, deep venous thrombosis, hardware complaints and secondary surgery. Regards the patients that have undergone surgical treatment.	5 years