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Stability and Outcomes of Non-displaced Lisfranc Injuries

Primary Purpose

Lisfranc Injury, Sprain of Foot

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Minimally invasive stabilization of Lisfranc injuries
Conservative treatment
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lisfranc Injury focused on measuring Lisfranc injury, Weightbearing radiographs, Stress fluoroscopy, Homerun screw

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo university hospial
  • Østfold Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

Negative WB radiographs and stress fluoroscopy

Negative WB radiographs / positive stress fluoroscopy

Surgical cohort (Cohort 3)

Arm Description

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

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

Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort.

Outcomes

Primary Outcome Measures

Manchester-Oxford Foot Questionnaire (MOxFQ)
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)

Secondary Outcome Measures

American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Self-reported foot and ankle score (SEFAS)
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Visual Analogue Scale (VAS) for pain
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Short-Form (SF) 36
Patient reported score measuring quality of life and health status
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.
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.

Full Information

First Posted
June 10, 2020
Last Updated
April 28, 2023
Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04430101
Brief Title
Stability and Outcomes of Non-displaced Lisfranc Injuries
Official Title
Stability and Outcomes of Non-displaced Lisfranc Injuries - A Prospective Multicenter Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust
Collaborators
Oslo University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lisfranc Injury, Sprain of Foot
Keywords
Lisfranc injury, Weightbearing radiographs, Stress fluoroscopy, Homerun screw

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Participant
Masking Description
The participants will be blinded for the result of the stress fluoroscopy.
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative WB radiographs and stress fluoroscopy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Negative WB radiographs / positive stress fluoroscopy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Surgical cohort (Cohort 3)
Arm Type
Other
Arm Description
Patients with positive weightbearing radiographs will be operated on with minimally invasive technique and followed up as an independent cohort.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive stabilization of Lisfranc injuries
Intervention Description
Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)
Intervention Type
Procedure
Intervention Name(s)
Conservative treatment
Intervention Description
Patients with negative weightbearing radiographs will be treated conservatively
Primary Outcome Measure Information:
Title
Manchester-Oxford Foot Questionnaire (MOxFQ)
Description
Foot-Ankle specific PROM (0-100 with 0 representing the best possible outcome)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Midfoot score
Description
Widely used foot/ankle score (0-100 with 100 representing the best possible outcome)
Time Frame
5 years
Title
Self-reported foot and ankle score (SEFAS)
Description
Foot-Ankle specific PROM (0-48 with 48 representing the best possible outcome)
Time Frame
5 years
Title
Visual Analogue Scale (VAS) for pain
Description
Scores pain at rest and on activity (0-10 with 0 representing no pain)
Time Frame
5 years
Title
Short-Form (SF) 36
Description
Patient reported score measuring quality of life and health status
Time Frame
5 years
Title
Posttraumatic osteoarthritis
Description
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.
Time Frame
5 years
Title
Incidence of complications
Description
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marius Molund, MD
Organizational Affiliation
Ostfold Hospital Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo university hospial
City
Oslo
ZIP/Postal Code
0588
Country
Norway
Facility Name
Østfold Hospital Trust
City
Sarpsborg
State/Province
Østfold
ZIP/Postal Code
1714
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Stability and Outcomes of Non-displaced Lisfranc Injuries

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