The BFF trial: "The Better to Fix or Fuse study"

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. There is no gold standard for the treatment of these Lisfranc
injuries as described in literature.

We hypothesize that patients will have a better quality of life and less
complications during follow-up when undergoing a primary arthrodesis for
unstable fracture dislocations in the Lisfranc midfoot joints compared to open
reduction and internal fixation. Further, we expect this approach to be more
cost effective than the operative stabilization with retaining of the
dislocated joints, as patients will be exposed to reduced number of
reinterventions and hospital stay and/or prolonged use of pain medication,
without compromising functional outcome and gait.

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 quality of life, complications, functional outcomes and
cost effectiveness. We hypothesize that patients will have a better quality of
life and less complications during follow-up when undergoing a primary
arthrodesis for unstable fracture dislocations in the Lisfranc midfoot joints
compared to open reduction and internal fixation. Further, we expect this
approach to be more cost effective than the operative stabilization with
retaining the dislocated joints, as patients will be exposed to reduced number
of reinterventions and hospital stay and/or prolonged use of pain medication,
without compromising functional outcome and gait.

An open (non-blinded) prospective randomized controlled clinical trial.

Patients with Lisfranc fracture dislocation will be randomly allocated to
treatment with either primary arthrodesis or open reduction and internal
fixation.

The expectations of this study are that operative treatment is beneficial for
the patient with a unstable Lisfranc injury. The risk of specific complications
is low and generally similar in both operative treatment modalities. Primary
arthrodesis is expected to have improved results in functional scoring systems
with less secondary surgical procedures compared with open reduction and
internal fixation. Literature indicates that both treatment options from the
study are accepted for Lisfranc fracture dislocation. 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 standard of care.