Are powder-technology-built stems safe? A midterm follow-up registry study

Abstract

Background: Powder technology was developed to bring together the mechanical features and high porosity of titanium. However, the high porosity may theoretically compromise mechanical resistance. Literature is deficient about the use and safety profile of cementless femoral implants built using additive manufacturing (in particular electron beam melting technology, EBM). The purpose of this study was to evaluate the survival rates and the reason for revisions (especially implant breakage) of the first two EBM-built stems at a mid-term follow-up, using a joint arthroplasty registry. Methods: The registry of Prosthetic Orthopedic Implant (RIPO) was investigated about cementless stems implanted from 2010 to 2017. Stems built with EBM technology (Parva and Pulchra stems; Adler Ortho, Milan, Italy) were compared to all the other cementless stems implanted during the same period, acting as control group. The survival rates and reasons for revision were assessed. Results: No stem breakage occurred. At 5-year follow-up, the survival rates of the two cohorts were not statistically different (96.8% EBM stems, 98.0% standard cementless stems; p > 0.05). In the EBM stems, aseptic loosening occurred in 1.7% of the cases at the latest follow-up. Conclusions: This large cohort showed that mechanical resistance is not a concern in EBM stems at mid-term follow-up. However, larger populations and longer follow-ups are needed to further validate these results. [Figure not available: see fulltext.]