Towards evidence-based surgical interventions in patients with acquired brain injury and pes equinovarus deformity

Acquired brain injury is the leading cause of disability in the western world.
In patients with acquired brain injury, balance and gait impairments due to pes
equinovarus deformity are common and disabling. It predisposes to hindfoot
instability, reduced gait speed and distance, dependence on walking aids, pain
while walking, and ultimately reduced functional mobility.
In the chronic phase after acquired brain injury, training does not improve pes
equinovarus. Therefore, the emphasis of management should be on
medical-technical interventions. Both nationally and internationally, however,
there is relative underuse of surgical treatment options, although in our
clinical experience this often has the best outcome.
In 2019, our group published a pilot observational study reporting a 30%
increase in gait speed after surgical interventions. These preliminary results
suggest surgical interventions for pes equinovarus deformity improve gait
capacity in chronic stroke patients, and that the degree of improvement is of
great clinical relevance. Further substantiation using clinical trials and a
better understanding of the underlying mechanism is now needed.

The primary objective of this study is to evaluate the effect of surgical
correction of pes equinovarus deformity compared to conservative treatment on
personalized goal attainment. In addition, we will evaluate the effect of
surgical correction of pes equinovarus deformity on gait capacity and the
quantity and quality of daily life gait performance.

Observational intervention with repeated-measures. Additionally, a database
that contains the measurements of people who have visited the Sint
Maartenskliniek for routine clinical care will be analyzed in this study.

All patients will receive a personalized surgical intervention to obtain
optimal stability of the foot in the frontal plane. The personalized surgical
intervention is part of routine clinical care at the Sint Maartenskliniek. It
consists of a fusion of one or more tarsal joints in combination with other
interventions such as the fixation of the interphalangeal toe joints, Achilles
tendon lengthening, or other tendon releases/ lengthenings/ transfers.

There are no serious risks associated with participation in this study. Many
measurements that will be performed in this study are already part of routine
clinical care within the LEC. The additional measurements do not lead to
increased risk, since appropriate safety measures will be taken such as wearing
a safety harness to prevent falling during the regular walking task and while
performing precision stepping and small perturbations in the Gait Real-time
Analysis Interactive Lab (GRAIL).
The subjects will visit the clinic three times for performing measurements. Two
visits are already part of routine clinical care. It is estimated that the
measurements will take 5 hours in total in addition to the regular clinical
treatment trajectory.