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The BFF Study- The Better to Fix or Fuse Study

NCT04519242 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2021-06-29

No results posted yet for this study

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.

Conditions

  • Lisfranc Fracture
  • Arthrodesis
  • Internal Fixation
  • Quality of Life

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Maastricht University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2022-06-25
Completion
2024-06-25

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04519242 on ClinicalTrials.gov