Purpose: To summarize the biological effects of metal debris from hip arthroplasties which characterize a polymorphic clinical spectrum of local and remote manifestation.
Methods: Retrospective study. Patient, implant, and surgical characteristics were collected, including implant survival, clinical manifestations, cause of arthroplasty revision or implant failure, and peri- and intra-operative complications. The primary endpoint was implant survivorship. Hip revision arthroplasty was decided considering clinical signs and symptoms, abnormal imaging (XR, MR, TC, echotomography, scintigraphy), and blood metal ion level. An ad hoc electronic form was used to collect demographic, epidemiological, and clinical variables. In-between group comparisons of quantitative variables were performed with the Student t test and the Mann-Whitney for parametric and non-parametric variables, respectively. Logistic regression analyses were carried out to assess the relationship between clinical and radiographic characteristics and stem and cup revision. Radiographic measurements of implant positioning validity and reliability were assessed using Krippendorff's alpha reliability coefficient. The statistical software STATA version 15 (StatsCorp, TX) was used to perform statistical computations.
Results: In this MoM THA series, the most incident cause of implant failure was ARMD in 11 out of 14 (78.6%) patients. All clinical failure manifestations, revision surgery highlights, and intra-operative findings are reported.
Conclusions: The local adverse reactions include lesions of different clinical relevance from small asymptomatic soft tissue lesions to dramatic osteolysis, necrosis, effusion, and growing masses which can cause secondary pathological effects. Symptoms of systemic toxicity are rarely described but may have been largely unreported in literature. Despite the extensive literature on the topic, the patient's management is still uncertain and challenging. Every metallic implant (e.g., screws, plates, spinal instrumentations) has a potential local or systemic adverse effect. Organizing a national registry of arthroplasty should be mandatory, in order to collect data about the patients, the surgery, the implanted device (with a careful post-marketing tracking), and the follow-up for all the procedures performed at a national level. The data collected in the registry will allow to analyze the implant survival and to better recognize the undesirable and sometimes unexpected effects of different biomaterials on the whole body.
Keywords: ALVAL; ARMD; Biomaterials; Metal ions; Metallosis; Pseudotumours; Total hip arthroplasty.