Stability and Outcomes of Non-displaced Lisfranc Injuries

NCT04430101 | Active Not Recruiting

• 1 other identifier: 20/00913
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Lisfranc Injury; Sprain of Foot

Keywords

Lisfranc injury; Weightbearing radiographs; Stress fluoroscopy; Homerun screw

Outcome Measures

Primary Outcomes (1)

• Manchester-Oxford Foot Questionnaire (MOxFQ)

  Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)

  5 years

Secondary Outcomes (6)

• American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score

  5 years

• Self-reported foot and ankle score (SEFAS)

  5 years

• Visual Analogue Scale (VAS) for pain

  5 years

• Short-Form (SF) 36

  5 years

• Posttraumatic osteoarthritis

  5 years

Study Arms (3)

Negative WB radiographs and stress fluoroscopy

ACTIVE COMPARATOR

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

Negative WB radiographs / positive stress fluoroscopy

ACTIVE COMPARATOR

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

Surgical cohort (Cohort 3)

OTHER

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

Interventions

Minimally invasive stabilization of Lisfranc injuries PROCEDURE

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

Surgical cohort (Cohort 3)

Conservative treatment PROCEDURE

Patients with negative weightbearing radiographs will be treated conservatively

Negative WB radiographs / positive stress fluoroscopy; Negative WB radiographs and stress fluoroscopy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• Oslo University Hospital: collaborator

Study Sites (2)

Oslo university hospial

Oslo, 0588, Norway

Location

Østfold Hospital Trust

Sarpsborg, Østfold fylke, 1714, Norway

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marius Molund, MD

  Ostfold Hospital Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be blinded for the result of the stress fluoroscopy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are evaluated by weightbearing radiographs. Patients with no signs of dislocation on the weightbearing radiographs will undergo stress fluoroscopy. Patients with negative stress fluoroscopy are allocated to Cohort 1, patients with positive stress fluoroscopy are allocated to Cohort 2. The study design is a non-inferiority study, proving to show that the outcomes of Cohort 2 are non-inferior compared to Cohort 1. Patients with positive weightbearing radiographs (interval between medial cuneiform and base of second metatarsal increased by \> 2 mm compared to the contralateral side) will be operated with minimally invasive stabilization (eg. isolated "homerun screw") and followed up prospectively as a single cohort (Cohort 3).

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: June 9, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)