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NCT Number: NCT04430101

Stability and Outcomes of Non-displaced Lisfranc Injuries

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lisfranc Injury Sprain of Foot

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Østfold Hospital Trust, Sarpsborg, Østfold fylke, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimally invasive stabilization of Lisfranc injuries

Procedure

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

Conservative treatment

Procedure

Patients with negative weightbearing radiographs will be treated conservatively

Primary outcomes

  1. Manchester-Oxford Foot Questionnaire (MOxFQ)

    Time frame: 5 years

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

Secondary outcomes

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

    Time frame: 5 years

    Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)

  2. Self-reported foot and ankle score (SEFAS)

    Time frame: 5 years

    Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)

  3. Visual Analogue Scale (VAS) for pain

    Time frame: 5 years

    Scores pain at rest and on activity (0-10 with 0 representing no pain)

  4. Short-Form (SF) 36

    Time frame: 5 years

    Patient reported score measuring quality of life and health status

  5. Posttraumatic osteoarthritis

    Time frame: 5 years

    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.

  6. Incidence of complications

    Time frame: 5 years

    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.

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Jun 12, 2020
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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