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Lisfranc FractureNCT04519242

The BFF Study- The Better to Fix or Fuse Study

A study testing Surgery in people with Lisfranc Fracture and Arthrodesis, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the proposed study is to define the optimal treatment for Lisfranc fracture-dislocation, either primary arthrodesis (PA) or open reduction and internal fixation (ORIF), regarding the quality of life, complications, functional outcomes, and cost-effectiveness. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lisfranc Fracture, Arthrodesis, Internal Fixation
What is being tested?
Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteNetherlands
Study dates
25 Jun 2020to 25 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years
  • Acute Lisfranc fracture injury (< 6 weeks after trauma)
  • Displaced or unstable with weight-bearing radiographs
  • Independent for activities of daily living (yes/no question)

Who cannot join

  • Open Lisfranc injury
  • Pure ligamentous Lisfranc injury
  • Non-displaced and stable with weight-bearing radiographs
  • Contra-indications for general or locoregional anesthetic techniques
  • Other fractures at the ipsilateral leg
  • Pre-existent abnormalities at the Lisfranc complex
Show all 12Show fewer
  • Pre-existent immobility
  • Dependent on activities of daily living (due to dementia, Alzheimer, NYHA class IV angina and heart failure, oxygen-dependent COPD)
  • Rheumatoid arthritis
  • Pathologic fractures (metastasis, secondary osteoporosis)
  • Peripheral neuropathy and/or diabetes
  • Alcohol- or drug abuse preventing adequate follow-up

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting
  • Maastricht University

    Maastricht, Limburg

    M Poeze, MD,PhD, MSc, +31-43-3871956, m.poeze@mumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: The BFF Study- The Better to Fix or Fuse Study 'Retaining or Removing the Joint in the Foot: A Randomized Controlled Multicenter Trial of Primary Arthrodesis Versus Joint Stabilisation in Lisfranc Fracture Dislocation Midfoot Injuries

The aim of the proposed study is to define the optimal treatment for Lisfranc fracture-dislocation, either primary arthrodesis (PA) or open reduction and internal fixation (ORIF), regarding the quality of life, complications, functional outcomes, and cost-effectiveness. The investigators hypothesize that patients will have a better quality of life and fewer complications during follow-up when undergoing a PA for unstable fracture-dislocations in the Lisfranc midfoot joints compared to ORIF. Further, the investigators expect this approach to be more cost-effective than the operative stabilization with retaining the dislocated joints, as patients will be exposed to a reduced number of reinterventions and hospital stay and/or prolonged use of pain medication.

Read the detailed description

SUMMARY

Rationale: The Lisfranc injury is a complex injury of the midfoot. It can result in persistent pain and functional impairment if treated inappropriately. In Lisfranc fracture-dislocation treatment options are primary arthrodesis of the midfoot joints or open reduction and internal fixation with retaining of the midfoot joints.

Objective: The aim of the proposed study is to define optimal treatment for the Lisfranc fracture-dislocation, either primary arthrodesis or open reduction and internal fixation, in regard to the quality of life, complications, functional outcomes and cost-effectiveness. The investigators hypothesize that patients will have a better quality of life and fewer complications during follow-up when undergoing a PA for unstable fracture-dislocations in the Lisfranc midfoot joints compared to ORIF. Further, the investigators expect this approach to be more cost-effective than the operative stabilization with retaining the dislocated joints, as patients will be exposed to a reduced number of reinterventions and hospital stay and/or prolonged use of pain medication.

Study design: A multicenter prospective randomized controlled clinical trial. Study population: All patients from 18 years and older with an acute (<6 weeks) traumatic fracture-dislocation in the Lisfranc midfoot joints, displaced or unstable with weight-bearing radiographs, and are eligible for either one of the surgical procedures. In total, this study will include n=112 patients with Lisfranc fracture-dislocation.

Intervention (if applicable): Patients with Lisfranc fracture-dislocation will be randomly allocated to treatment with either PA or ORIF.

Main study parameters/endpoints: The quality of life. Secondary outcomes: complications, functional outcomes, and cost-effectiveness.

Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:

The expectation of this study is that operative treatment is beneficial for the patient with an unstable Lisfranc injury. The risk of specific complications is low and generally similar in both operative treatment modalities. PA is expected to have improved results in functional scoring systems with less secondary surgical procedures compared to ORIF. Literature indicates that both treatment options from the study are accepted for Lisfranc fracture injury. No clear advantage for one treatment option is found at present in the literature.

The burden of the study seems to be not much higher compared to standard treatment because follow-up is standardized according to current trauma guidelines. The radiation exposure will not be different from the standard of care.

Being tested
Surgery
Medical subject headings
Ankylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    ORIF will be done by using bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). For fixation TMT4 and/or TMT5 K-wires (1.6 or 2.0mm) can be used instead.

    PA will be done by removal of articular surface and subsequent stabilization with bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS).

    Type and sequence of fixation of the involved rays as needed, partial or complete fixation as needed, judgement by treating surgeon.

Study groups in NCT04519242
Study groupRoleWhat they receive
Patients enrolled in the ORIF groupActive comparatorOpen reduction and internal fixation (ORIF), ORIF will be done by using bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). For fixation, TMT4 and/or TMT5 K-wires (1.6 or 2.0mm) can be used instead.
Receives: Procedure: Surgery
Patients enrolled in the PA groupActive comparatorPA will be done by removal of the articular surface and subsequent stabilization with bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS).
Receives: Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The 5 level EQ-5D version (EQ-5d-5L) questionnaire

    This validated questionnaire (as defined by the EQ-5D-5L questionnaire) is a descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension. When the patients has no problems at the dimension, f.e. mobility, this is coded as "1".

    LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/extreme problems

    Measured: 2-year follow up period

Secondary outcomes (7)
  1. American Orthopaedic Foot and Ankle Society Score (AOFAS)

    The Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire of patient-relevant outcomes in five, questionnaire for patients who have musculoskeletal disorders of the upper and lower extremities, for the ankle- hindfoot, midfoot, hallux, and lesser toes.

    It incorporates both subjective and objective information. Patients report their pain, and physicians assess alignment. The patient and physician work together to complete the functional portion. Scores range from 0 to 100, with a healthy midfoot receiving 100 points.

    Measured: 2 year follow up period

  2. Foot And Ankle Disability Index (FADI)

    The Foot and Ankle Disability Index is a 34-item questionnaire divided into two subscales: the Foot and Ankle Disability Index and the Foot and Ankle Disability Index Sport. The FADI has 26 items, and the FADI Sport has 8. The FADI contains 4 pain related items and 22 activity related items. The FADI Sport contains 8 activity related items. It assesses more difficult tasks that are essential to sport.

    Each of the 34 items is scored on a 5-point Likert scale from 0 (unable to do) to 4 (no difficulty at all). The 4 pain items of the FADI are scored 0 (none) to 4 (unbearable). The FADI has a total point value of 104 points, whereas the FADI Sport has a total point value of 32 points. The FADI and FADI Sport are scored separately as percentages, with 100% representing no dysfunction.

    Measured: 2 year follow up period

  3. Alignment of the foot on weight-bearing X-rays

    Radiographs will be interpreted as follow: Instability, e.g. displacement or malalignment will be described as:

    • AP view Lateral displacement of 2nd metatarsal on intermediate cuneiform, medial margin of the second metatarsal and the middle cuneiform not aligned; TMT 1 disruption, lateral margin of the first metatarsal not aligned with the lateral margin of the medial cuneiform; Gap between 1st and 2nd metatarsal and/or ceuneiforme medialis and intermedius (>2mm);
    • 30 degree oblique view Lateral displacement of 3rd metatarsal on lateral cuneiform, lateral margin of the third metatarsal and the lateral cuneiform not aligned; Medial margin of the fourth metatarsal and cuboid not aligned;
    • lateral view Dorsal displacement of the metatarsal bases above the level of the cuneiforms.
    • any view Bony avulsion fractures between base 2nd metatarsal and cuneiforme medialis (fleck sign), and/or between cuneiforme medialis and intermedius.

    Measured: 2 year follow up period

  4. Medical Consumption Questionnaire (MCQ)

    Medical consumption is measured on the basis of 29 questions.The scoring for items starting with "How many appointments did you have ..." is as follows. The number of agreements that the respondent mentions will be adopted. When the respondent has ticked "No appointment at all" a 0 is entered. When the respondent has nothing checked, this should be considered as missing information. Data regarding care items in which a distinction is made between different types of care collected based on multiple questions. The first question about the item in question is always oneselection question. Respondents ticking "No" can skip the following questions and are referred to the next care item via the routing. The answer "No" is scoredwith a 2. The missing values for questions that can be skipped arecoded as a valid missing. Respondents who answer "Yes" are asked further to proceed with the following questions. This asks for a specification of the care item and the number of care received.

    Measured: 2 year follow up period

  5. Occurrence of complications

    most important being post-traumatic arthritis, infection, non-union

    Measured: 2 year follow up period

  6. 12-Item Short Form Health Survey (SF-12)

    The SF-12 measures eight health aspects, namely physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.

    Measured: 2- year follow up period

  7. Productivity Cost Questionnaire (PCQ)

    Questions 1 to 3 provide information about the amount of paid work (in hours) and the number of days per week on which the person works. The latter provides insight into the average number of hours of work per working day of the respondent. This information is needed to calculate productivity loss costs.

    The questions about productivity losses form the following modules: - Absenteeism: absenteeism from paid work (questions 4 to 6) - 'Presenteeism': productivity losses during days worked (questions 7 to 9) - Productivity loss from unpaid work (questions 10 to 12).

    Absenteeism:

    The total amount of absenteeism is then calculated by multiplying the number of days absent and the number of hours per working day of the respondent.

    To calculate the costs of productivity losses, volumes are multiplied by unit cost prices.

    Measured: 2-year follow up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2020
  2. Study start25 Jun 2020
  3. Primary completion25 Jun 2022 (estimated)
  4. Study completion25 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04519242
Sponsor's protocol ID
NL73038.096.20
Status last verified
Jun 2021
First submitted
13 Aug 2020
Last updated
29 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van den Boom NAC, Stollenwerck GANL, Evers SMAA, Poeze M. Effectiveness and cost-effectiveness of primary arthrodesis versus open reduction and internal fixation in patients with Lisfranc fracture instability (The BFF Study) study protocol for a multicenter randomized controlled trial. BMC Surg. 2021 Aug 12;21(1):323. doi: 10.1186/s12893-021-01320-1.

    PubMed 34384419

Questions about this trial

What is this clinical trial studying?

A study testing Surgery in people with Lisfranc Fracture and Arthrodesis, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Noortje van den Boom, MD (0031620627189, n.vandenboom@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The 5 level EQ-5D version (EQ-5d-5L) questionnaire (time frame: 2-year follow up period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04519242, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2021.

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