ObjectiveClinical studies of patients with bone sarcomas have been challenged
by insufficient numbers at individual centres to draw valid conclusions.
Our objective was to assess the feasibility of conducting a definitive
multi-centre randomised controlled trial (RCT) to determine whether
a five-day regimen of post-operative antibiotics, in comparison
to a
24-hour regimen, decreases surgical site infections in patients
undergoing endoprosthetic reconstruction for lower extremity primary
bone tumours. MethodsWe performed a pilot international multi-centre RCT. We used
central randomisation to conceal treatment allocation and sham antibiotics
to blind participants, surgeons, and data collectors. We determined
feasibility by measuring patient enrolment, completeness of follow-up,
and protocol deviations for the antibiotic regimens. ResultsWe screened 96 patients and enrolled 60 participants (44 men
and 16 women) across 21 sites from four countries over 24 months
(mean 2.13 participants per site per year, standard deviation 2.14).
One participant was lost to follow-up and one withdrew consent.
Complete data were obtained for 98% of eligible patients at two
weeks, 83% at six months, and 73% at one year (the remainder with
partial data or pending queries). In total, 18 participants missed
at least one dose of antibiotics or placebo post-operatively, but
93% of all post-operative doses were administered per protocol. ConclusionsIt is feasible to conduct a definitive multi-centre RCT of post-operative
antibiotic regimens in patients with bone sarcomas, but further
expansion of our collaborative network will be critical. We have
demonstrated an ability to coordinate in multiple countries, enrol
participants, maintain protocol adherence, and minimise losses to
follow-up.Cite this article: Bone Joint Res;4:154–162