Stability and Outcomes of Non-displaced Lisfranc Injuries

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lisfranc Injury; Sprain of Foot
• Intervention / Treatment: Procedure: Conservative treatment; Procedure: Minimally invasive stabilization of Lisfranc injuries

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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0588
    • Oslo university hospial
  • Østfold
    • Sarpsborg, Østfold, Norway, 1714
      • Østfold Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Conservative treatment; Patients with negative weightbearing radiographs will be treated conservatively
Active Comparator: 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	Procedure: Conservative treatment; Patients with negative weightbearing radiographs will be treated conservatively
Other: Surgical cohort (Cohort 3); Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort.	Procedure: Minimally invasive stabilization of Lisfranc injuries; Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manchester-Oxford Foot Questionnaire (MOxFQ)	Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Self-reported foot and ankle score (SEFAS)	Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)	5 years
Visual Analogue Scale (VAS) for pain	Scores pain at rest and on activity (0-10 with 0 representing no pain)	5 years
Short-Form (SF) 36	Patient reported score measuring quality of life and health status	5 years
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
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

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Collaborators: Oslo University Hospital
• Investigators: Principal Investigator: Marius Molund, MD, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2029

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Lisfranc injury; Weightbearing radiographs; Stress fluoroscopy; Homerun screw
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 20/00913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No