Safety of a Porous Hydroxyapatite Bone Substitute in Orthopedics and Traumatology: A Multi-Centric Clinical Study

Abstract

The development of biomaterials in recent years has made it possible to broaden their use in the surgical field. Although iliac crest bone graft harvesting currently remains the gold standard as an autograft, the properties of hydroxyapatite bone substitutes appear to be beneficial. The first fundamental step to consider is the safety of using these devices. The purpose of this retrospective cohort study is to consider all the adverse events observed in our population and assess their relationships with the bone substitute device. The population analyzed consisted of patients undergoing trauma osteosynthesis with at least one implanted porous hydroxyapatite device. We considered a court of 114 patients treated at “Azienda Ospedaliera Universitaria di Ferrara—U.O. di Ortopedia e Traumatologia” in the period from January 2015 to December 2022. Upon analyzing our population, no adverse events related to the device emerged. Taking into consideration different study groups from other National Hospital Centers, no critical issues were detected except for three cases of extrusion of the biomaterial. It is necessary to clarify that bone substitutes cannot replace compliance with the correct principles linked to the biomechanics of osteosynthesis. This report outlines a safety profile for the use of these devices as bone substitutes in trauma orthopedic surgery.