The BFF Study- The Better to Fix or Fuse Study

NCT ID: NCT04519242

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2024-06-25

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.

Conditions

Lisfranc Fracture; Arthrodesis; Internal Fixation; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients enrolled in the ORIF group

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.

Group Type: ACTIVE_COMPARATOR

Surgery

Intervention Type: PROCEDURE

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.

Patients enrolled in the PA group

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).

Group Type: ACTIVE_COMPARATOR

Surgery

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Noortje van den Boom, MD

Role: CONTACT

n.vandenboom@maastrichtuniversity.nl

0031620627189

Facility Contacts

M Poeze, MD,PhD, MSc

Role: primary

m.poeze@mumc.nl

+31-43-3871956

References

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.

Reference Type: DERIVED

PMID: 34384419 (View on PubMed)

Other Identifiers

NL73038.096.20

Identifier Type: -

Identifier Source: org_study_id