Documentation

The successful completion of the first international bone infection registry, with integrated collection of biological samples and patient-reported outcomes.

Stephen Kates, Virginia Commonwealth University Richmond, United States
AO Clinical Investigation and Documentation, AO Foundation, Switzerland

The AO Trauma Clinical Priority Program (CPP) aims to discover solutions to the pressing and costly clinical problem of bone infections.

The lack of a dedicated registry for bone infection patients has hampered efforts to estimate the magnitude of bone infections on an international scale. Currently, there are no worldwide-accepted standards for data collection on bone infection cases. The "Bone Infection Registry", a project under the CPP umbrella, aimed to create an international registry (20 study sites around the world) on bone and joint infections with Staphylococcus aureus (S. aureus, both methicillin-resistant and -sensitive strains) for the purpose of collecting high quality, standardized information and biological samples. Parameters included in data collection were (1) baseline patient attributes, (2) surgical approaches, implants, and technologies, (3) hospital course, (4) surgeon and institutional characteristics, (5) patient outcomes, and (6) post-procedural complications and revisions. Since a major limitation in understanding and treating musculoskeletal infections is the lack of knowledge of host humoral responses during acute and chronic infections, this registry also collected biological samples. With these biological samples, we expect to identify and document the S. aureus strains involved in infections and the host humoral/immunological responses. This would be the first time infective organisms are linked to patient characteristics and clinical and patient-reported outcomes. It is the vision that the above-mentioned information should help develop new assessment tools for clinical practice and define treatment failure/success based on the clinical features included in the registry. The intention is to use the available data to construct a prognostic model of bone infection.

Despite the complexity of establishing such a registry on an international scale, the first stage of the registry has been successfully concluded. Eighteen study centers from Europe, America, and Asia recruited over 300 patients. Data analysis is ongoing; the first manuscript focused on lessons learned has been submitted and a second manuscript on the main clinical results is in preparation.