The diagnosis of surgical site infection following endoprosthetic reconstruction for bone tumours is frequently a subjective diagnosis. Large clinical trials use blinded Central Adjudication Committees (CACs) to minimise the variability and bias associated with assessing a clinical outcome. The aim of this study was to determine the level of inter-rater and intra-rater agreement in the diagnosis of surgical site infection in the context of a clinical trial. The Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial CAC adjudicated 29 non-PARITY cases of lower extremity endoprosthetic reconstruction. The CAC members classified each case according to the Centers for Disease Control (CDC) criteria for surgical site infection (superficial, deep, or organ space). Combinatorial analysis was used to calculate the smallest CAC panel size required to maximise agreement. A final meeting was held to establish a consensus.Objectives
Materials and Methods
We investigated the clinical outcome of internal
fixation for pathological fracture of the femur after primary excision of
a soft-tissue sarcoma that had been treated with adjuvant radiotherapy. A review of our database identified 22 radiation-induced fractures
of the femur in 22 patients (seven men, 15 women). We noted the
mechanism of injury, fracture pattern and any complications after
internal fixation, including nonunion, hardware failure, secondary
fracture or deep infection. The mean age of the patients at primary excision of the tumour
was 58.3 years (39 to 86). The mean time from primary excision to
fracture was 73.2 months (2 to 195). The mean follow-up after fracture
fixation was 65.9 months (12 to 205). Complications occurred in
19 patients (86%). Nonunion developed in 18 patients (82%), of whom
11 had a radiological nonunion at 12 months, five a nonunion and
hardware failure and two an infected nonunion. One patient developed
a second radiation-associated fracture of the femur after internal
fixation and union of the initial fracture. A total of 13 patients
(59%) underwent 24 revision operations. Internal fixation of a pathological fracture of the femur after
radiotherapy for a soft-tissue sarcoma has an extremely high rate
of complication and requires specialist attention. Cite this article: