Clinical trial NCT04519242: The BFF Study- The Better to Fix or Fuse 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lisfranc Fracture
Arthrodesis
Internal Fixation
Quality of Life
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2020-08-19
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The 5 level EQ-5D version (EQ-5d-5L) questionnaire
timeFrame: 2-year follow up period
Secondary outcomes:
measure: American Orthopaedic Foot and Ankle Society Score (AOFAS)
timeFrame: 2 year follow up period
measure: Foot And Ankle Disability Index (FADI)
timeFrame: 2 year follow up period
measure: Alignment of the foot on weight-bearing X-rays
timeFrame: 2 year follow up period
measure: Medical Consumption Questionnaire (MCQ)
timeFrame: 2 year follow up period
measure: Occurrence of complications
timeFrame: 2 year follow up period
measure: 12-Item Short Form Health Survey (SF-12)
timeFrame: 2- year follow up period
measure: Productivity Cost Questionnaire (PCQ)
timeFrame: 2-year follow up period
Other outcomes:
measure: Amount and type of secondary procedures
timeFrame: 2-year follow up period
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
citation: 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.