ROutine versus on DEmand removal Of the syndesmotic stabilisation screw; a randomized controlled trial

Ankle fractures are among the most common fractures. It is estimated that more
than 25000 people suffer from an ankle
fracture in the Netherlands annually and the incidence is rising. Both young
and elderly people are at risk for these fractures.
In general younger people are more at risk as a result of a more active
lifestyle and elderly people because of poorer bone
quality. Approximately half of the patients with an ankle fracture require
surgical treatment because of joint instability. In
approximately 20% of these fractures there is a concomitant injury of the
syndesmosis and syndesmotic repair is indicated. A
syndesmotic *positioning screw* is placed through the fibula into the tibia to
assure stability and allow the syndesmotic
ligaments to heal. Elaborate research has been conducted regarding the
technical aspects of the placement of the syndesmotic
screw. For example, the number of required screws, its diameter, level of
placement and whether it should engage three or four
cortices has been investigated thoroughly.
After a period of 8 * 10 weeks the syndesmosis will be healed and the screw
will lose its function. It is an ongoing discussion
whether the syndesmotic screw needs to be removed subsequently. Most surgeons
advocate its removal because of suspected
impaired range of motion and chance of breakage of the screw. During normal
ambulation the fibula moves and the
syndesmosis widens. The positioning screw is thought to restrict this movement
and the screw is therefore removed
after 8 * 12 weeks. However, several case series have shown similar outcomes in
patients in which the syndesmotic screw was
retained compared to patient in whom the syndesmotic screw was removed. The
positioning screw is most likely not
causing complaints in patients with retained screws because of loosening or
breakage of the screw. Currently there is
not enough evidence for neither routine removal and removal on demand,
providing such evidence is desirable for both
physicians and patients

Primary Objective: To demonstrate that a on demand removal strategy of the
syndesmotic positioning screw is non-inferior in functional outcome compared
with routine removal of the syndesmotic positioning screw.

Secondary Objective(s): We aim to compare ankle function and amount of adverse
events between the two treatment strategies. Lastly, we intent to investigate
the socio-economic impact of our intervention.

The study will be a pragmatic, multicenter randomized controlled
non-inferiority trial. The study will compare a removal on demand strategy with
a routine removal strategy regarding the syndesmotic screw. We will advocate a
preferred method of fixating the syndesmosis (i.e. one 3,5 mm screw through 3
cortices). However, the pragmatic design means that the final decision
technical details regarding the placement of the screw (e.g. number of
screw(s), size of the screw(s) and number of cortices engaged) are left at the
discretion of the operating surgeon. In total the duration of the study will be
three years. Inclusion will take approximately two years and the follow-up
lasts one year. An overview of the study is shown in figure 1. The follow-up
moments will take place 3, 6 and 12 months following surgery for the ankle
fracture.

On demand removal of the syndesmotic screw, removal is only performed in case
of symptomatic hardware such as painful
hardware or hardware (supposedly) causing restricted range of motion

The risks in this study are acceptable for the patients participating in this
study as both treatment options are well-known and safe, furthermore are they
both part of daily practice. Furthermore, no extra visits or longer follow-up
are required for the study.