The BFF Study- The Better to Fix or Fuse Study

Maastricht University Medical Centre (MUMC)

Status: Enrolling

Conditions: Lisfranc Fracture; Quality of Life; Internal Fixation; Arthrodesis

Treatments: Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04519242

NL73038.096.20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Patients enrolled in the ORIF group

Active Comparator group

Description:

Open 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.

Treatment:

Procedure: Surgery

Patients enrolled in the PA group

Active Comparator group

Description:

PA 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).

Treatment:

Procedure: Surgery