Summary. The M2a-38. tm. metal on metal total hip arthroplasty showed a high incidence of pseudotumors and an unexpected high revision rate in our thoroughly screened cross sectional cohort. Introduction. After the revival of the metal on metal (MoM) bearing in total hip arthroplasty (THA) at the beginning of this century, there are now serious questions about this type of bearing. The advantage of large head MoM bearing is the increase in range of motion and stability. In our institution the choice was made for 38 mm heads. During the last few years concerns have been raised about the relationship of MoM bearing and elevated serum cobalt and chromium ion levels, their local and systemic toxicological effects and the incidence of local tumorous masses (pseudotumors). Are these findings applicable for all MoM bearings or are there also product specific issues. We present the outcome of a cementless MoM THA using a 38mm head in a unique consecutive series of 377 THA who were performed in our institution. Patients and Methods. All 351 patients (377 THA) with a cementless MoM THA (M2a-38. tm. , Biomet Inc, Warsaw, IN, USA, and Taperloc® stem, Biomet UK, Bridgend) between 2008 and 2011 were evaluated. All patients were analyzed by a physical exam, serum levels of cobalt and chromium and an interview to determine if there were any complaints. An MRI of the hip was made if patients reported pain during physical activity, allergies to metals, serum cobalt or chromium ion levels ≥ 5 ppb or if the inclination of the acetabular component was more than 50 degrees. Nine patients deceased, three were lost to follow up and four already underwent a revision before the screening. We analyzed 361 hips with an average follow up of 30 (range 2–58) months. The average preoperative age was 63 years (41–88). Results. 219 patients with 235 THA (65%) reported no complaints. Median cobalt level in patients with complaints was 6.6 (0.2–173) ppb and in the group without complaints 3.7 (0.2–27.3) ppb. Median chromium level in patients with complaints was 5.0 (0.1–134) ppb and in the group without complaints 3.7 (0.2–27) ppb. On the 226 performed MRI scans, 56 pseudotumors were diagnosed and described using the Anderson classification (9 C1, 41 C2 and 5 C3). 71 hips had been revised after a mean follow of 30 months (range 0.2–50 months). Reasons for revision were because of pain, raised metal ions and a pseudotumor in 28; pain and raised metal ion levels in 15; aseptic loosening of the acetabular or femoral component in 11; raised metal ions and a pseudotumor in 7; combination of luxations, luxation feelings and fractures in 5; infections in 3 and for other reasons in 2. Conclusion. The short-term results of the THA with a 38mm head metal on metal articulation are higher compared with other MoM bearings. They show a revision rate of 7% and 10% in the Australian and England register. In other peer reviewed literature we find a revision rate between 0–13% after five years. We also observed a high incidence of elevated serum levels of metal ions, pseudotumors and an unexpected high early revision rate

The biological reaction in metallosis and pseudotumor generation after metal on metal total hip arthroplasty or corroding metal implants remains unsettled. Clinically, still lethal cases appear with massive bone loss and metal ions are suspected to be responsible for this inflammatory reaction, solid metal wear particles instead are usually not observed in the common literature. The aim of this study was to compare the biological reactions of metal ions and metal wear particles in a murine in vivo model. Metal ions (CoCr), metal particles (CoCr), polyethylene particles (UHMWPE) and phosphate buffered saline (PBS) were injected into the left knee joint of female BALB/c mice. 7 days after injection, the microcirculation was observed using intravital fluorescence microscopy, followed by euthanasia of the animals. After the assessment of the knee diameter, the knees underwent histological evaluations of the synovial layer. Throughout all recorded data, CoCr particles caused higher inflammatory reactions compared to metal ions and UHMWPE particles. The mice treated with the solid particles showed enlarged knee diameters, more intensive leukocyte–endothelial cell interactions and an elevated functional capillary density. Pseudotumor-like tissue formations in the synovial layer of the mice were only seen after the exposition to solid CoCr particles. Even if the focus of several national guidelines concerning metallosis and pseudotumor generation is on metal ions, the present data reveal that solid CoCr particles have the strongest inflammatory activity compared with metal ions and UHMWPE particles in vivo

Summary. Five year migration results of 49 large-head metal-metal (MoM) total hip arthroplasties show good implant stability and no association between implant migration and metal-ions levels, stem and cup position, or femoral bone mineral density. Introduction. The failure mechanism of metal-metal (MoM) total hip arthroplasty has been related to metal wear-debris and pseudotumor, but it is unknown whether implant fixation is affected by metal wear-debris. Patients and Methods. In July-August 2012 41 patients (10 women) at a mean age of 47 (23–63) years with a total of 49 MoM hip arthroplasties (ReCap Shell/M2a-Magnum head/Bi-Metric stem; Biomet Inc.) participated in a 5–7 year follow-up with blood tests (chrome and cobalt serum ions), questionnaires (Oxford Hip Score (OHS) and Harris Hip Score (HHS), measurement of cup and stem position and periprosthetic BMD. Further the patients had been followed with stereo-radiographs post-operative and at 1, 2 and 5 years for analysis of implant migration (Model-Based RSA 3.32). Results. 4 patients (6 hips) had elevated metal-ion levels (>7ug/l). The mean cup inclination was 45°(sd 6), the mean cup anteversion was 17°(sd7), and the mean stem anteversion was 19°(sd7). The difference between genders was statistically insignificant (p>0.09). At 5 years follow-up total translation (TT) for the stems (n=39 hips) was a mean 0.79mm (sd 0.53) and total rotation (TR) was a mean 1.99° (sd 1.53). Between 1–2 years there was no significant difference in mean TT (p=0.49)for the stems and between 2–5 years TT was mean 0.13 mm (sd 0.35) which was significant (p=0.03) but clinically very small and within the precision limits of the method. We found no significant migration along the 3 separate axes. There was no significant association between stem migration and metal ion levels >7ug/l (p=0.55), female gender (p=0.86), stem anteversion > 25° (p=0.29), T-scores < −1 (p=0.23), total OHS < 40 (p=0.19) or total HHS < 90 (p=0.68). Between 1–5 years there was no significant change in neither subsidence (p=0.14) nor in version (p=0.91) of the stems. At 5 years TT for the cups (n=36) was mean 1.21 mm (sd 0.74) and TR was mean 2.63° (sd 1.71). Between 1–2 years cup migration along the z-axis was mean 0.29 (sd 0.73) (p=0.03), which was also within precision limits of the method. There was a positive association between total OHS below 40 (n=4) and cup migration (p=0.04), but no association between cup migration and metal ion levels >7ug/l (p=0.80), female gender (p=0.74), cup inclination > 50° (p=0.93), cup anteversion > 25° (p=0.88) or HHS < 90 (p=0.93). Proximal cup migration at 5 years was mean 0.46 mm (sd 0.47), which was similar to the cup migration at 1 year (p=0.91) and 2 years (p=0.80) follow-up. No patients were revised before the final 5–7 year follow-up. Patient satisfaction was high (94%). Conclusion. All cups and stems were well-fixed between 1–5 years. We found no statistical significant correlation between implant migration and other factors that have been associated with failure of MoM hip arthroplasty such as elevated metal ion levels, component position, and female gender. Cup migration was higher in patients with a total OHS below 40. In conclusion, metal wear-debris does not seem to influence fixation of hip components in large-head MoM articulations at mid-term follow-up