F. Hannemann

European multidisciplinary consensus statement on the use and monitoring of metal-on-metal bearings for total hip replacement and hip resurfacing.

INTRODUCTION There is an ongoing debate about the optimal use of metal-on-metal (MoM) bearings in total hip replacement, since there are uncertainties about local and systemic adverse effects due to wear and corrosion of these bearings. Despite various national recommendations, efforts to achieve international harmonization of specific evidence-based recommendations for best practice are still lacking. HYPOTHESIS An international consensus study group should be able to develop recommendations on the use and monitoring of MoM bearings, preferably at the European level, through a multidisciplinary approach, by integrating the perspectives of various stakeholders. MATERIALS AND METHODS Twenty-one experts representing three stakeholder groups and eight countries participated in this European consensus study, which consisted of a consensus meeting, subsequent structured discussion, and consensus voting. RESULTS The current statement defines first of all benefits, local and systemic risks, as well as uncertain issues related to MoM bearings. Safety assessment after implantation of MoM comprises all patients. A closer follow-up is recommended for large head MoM (≥36mm) and resurfacing. In these implants basic follow-up should consist of x-rays and metal ion measurement of cobalt in whole blood, performed with GF-AAS or ICP-MS. Clinical and/or radiographic abnormality as well as elevated ion levels needs additional imaging (ultrasound, CT-scan and/or MARS-MRI). Cobalt values less than 2 μg/L are probably devoid of clinical concern, the threshold value for clinical concern is expected to be within the range of 2-7 μg/L. DISCUSSION This is the first multinational, interdisciplinary, and multiprofessional approach for developing a recommendation for the use and monitoring of MoM bearings in total hip replacement. The current recommendations are in partial agreement with previous statements regarding the extent of follow-up and imaging techniques. They however differ from previous communications regarding measurement of metal ions and especially the investigated medium, technique, and eventual threshold levels. LEVEL OF EVIDENCE Level V, expert opinion/agreement conference.

Metal ion concentrations in body fluids after implantation of hip replacements with metal-on-metal bearing--systematic review of clinical and epidemiological studies.

Introduction The use of metal-on-metal (MoM) total hip arthroplasty (THA) increased in the last decades. A release of metal products (i.e. particles, ions, metallo-organic compounds) in these implants may cause local and/or systemic adverse reactions. Metal ion concentrations in body fluids are surrogate measures of metal exposure. Objective To systematically summarize and critically appraise published studies concerning metal ion concentrations after MoM THA. Methods Systematic review of clinical trials (RCTs) and epidemiological studies with assessment of metal ion levels (cobalt, chromium, titanium, nickel, molybdenum) in body fluids after implantation of metalliferous hip replacements. Systematic search in PubMed and Embase in January 2012 supplemented by hand search. Standardized abstraction of pre- and postoperative metal ion concentrations stratified by type of bearing (primary explanatory factor), patient characteristics as well as study quality characteristics (secondary explanatory factors). Results Overall, 104 studies (11 RCTs, 93 epidemiological studies) totaling 9.957 patients with measurement of metal ions in body fluids were identified and analyzed. Consistently, median metal ion concentrations were persistently elevated after implantation of MoM-bearings in all investigated mediums (whole blood, serum, plasma, erythrocytes, urine) irrespective of patient characteristics and study characteristics. In several studies very high serum cobalt concentrations above 50 µg/L were measured (detection limit typically 0.3 µg/L). Highest metal ion concentrations were observed after treatment with stemmed large-head MoM-implants and hip resurfacing arthroplasty. Discussion Due to the risk of local and systemic accumulation of metallic products after treatment with MoM-bearing, risk and benefits should be carefully balanced preoperatively. The authors support a proposed „time out“ for stemmed large-head MoM-THA and recommend a restricted indication for hip resurfacing arthroplasty. Patients with implanted MoM-bearing should receive regular and standardized monitoring of metal ion concentrations. Further research is indicated especially with regard to potential systemic reactions due to accumulation of metal products.

Consensus statement “Current evidence on the management of metal-on-metal bearings” - April 16, 2012

The following recommendations are based on expert opinions of an international multidisciplinary panel endorsed by the “European Federation of National Associations of Orthopaedics and Traumatology” (EFORT), the “European Hip Society” (EHS), the German “Arbeitsgemeinschaft Endoprothetik” (AE) and the “Deutsche Arthrosehilfe” (DAH)

[Update on metal-on-metal hip joints].

Increasing data are available describing risk factors for the development of local and systemic adverse events following operations using metal-on-metal (MoM) hip implants. The prevalence and clinical relevance of metal-associated problems are, however, still under debate. They can be influenced by type and position of implant as well as patient-specific factors. Patients with small MoM heads (maximum diameter 32 mm) and subgroups of resurfacing arthroplasty can achieve good long-term survival. The use of large head MoM implants (diameters greater than 36 mm), however, is currently not advised due to the unsatisfactory results.

Update Metall-Metall-Gleitpaarungen

Increasing data are available describing risk factors for the development of local and systemic adverse events following operations using metal-on-metal (MoM) hip implants. The prevalence and clinical relevance of metal-associated problems are, however, still under debate. They can be influenced by type and position of implant as well as patient-specific factors. Patients with small MoM heads (maximum diameter 32 mm) and subgroups of resurfacing arthroplasty can achieve good long-term survival. The use of large head MoM implants (diameters greater than 36 mm), however, is currently not advised due to the unsatisfactory results.

Current Concepts in Metal-on-Metal Articulations

Total hip replacement (THR) for patients with osteoarthritis is one of the most successful surgical interventions in general inducing substantial improvement of health-related quality of life of affected patients [1]. Implant survival can be limited, however, by mechanical wear of bearing materials, which often leads to aseptic loosening. Increasing demands in young and physically active patient groups resulted in the development of bearing materials with improved wear characteristics. These “hard-on-hard”-bearings are characterized by potential combinations of highly cross-linked polyethylene, ceramic, or metal cup inserts with ceramic or metal heads.

Update Metall-Metall-Gleitpaarungen@@@Update on metal-on-metal hip joints

Increasing data are available describing risk factors for the development of local and systemic adverse events following operations using metal-on-metal (MoM) hip implants. The prevalence and clinical relevance of metal-associated problems are, however, still under debate. They can be influenced by type and position of implant as well as patient-specific factors. Patients with small MoM heads (maximum diameter 32 mm) and subgroups of resurfacing arthroplasty can achieve good long-term survival. The use of large head MoM implants (diameters greater than 36 mm), however, is currently not advised due to the unsatisfactory results.