Metal-on-metal Hip Implants Research Articles

Assessing the Clinical Value of Objective and Patient-Reported Audiovestibular Outcome Measures in the Risk Estimation of Systemic Cobalt Toxicity for Patients With a Metal-on-Metal Hip Implant.

Based on limited evidence from case reports and small cohort studies of metal-on-metal (MoM) hip implant patients with presumed systemic cobalt (Co) toxicity, and a few animal studies on Co-induced damage to the otovestibular system, it was hypothesised that Co exhibits an ototoxic potential alongside other systemic manifestations. Preliminary investigations from our research group in MoM patients confirmed this assumption for the auditory system, whereas no signs of Co-induced vestibular impairment were detected, and a clear dose-response relationship between the auditory function and the blood Co levels was lacking. Therefore, the current study aimed to extend and validate these findings in a larger sample of MoM patients and control subjects, to explore the potential clinical value of audiovestibular outcome measures in the risk estimation of systemic Co toxicity in this patient population. Fifty patients (32 to 68 years) with a primary unilateral/bilateral MoM hip implant were matched for age, gender, and noise exposure to 50 nonimplanted control subjects. Both groups underwent the same protocol, consisting of an objective auditory [i.e., conventional and high-frequency audiometry, transient-evoked and distortion (TEOAEs and DPOAEs), auditory brainstem responses] and vestibular (i.e., cervical and ocular vestibular evoked myogenic potentials, horizontal and vertical video head impulse tests) test battery, a questionnaire inquiring auditory, balance, and general neurological symptoms, and a blood sample collection to determine the plasma Co concentration. The auditory test battery presented consistently higher audiometric thresholds in the MoM patient group, with group differences ranging from 2.1 to 5.7 dB in the lower frequencies (0.25 to 6.0 kHz) and from 4.6 to 9.3 dB in the high frequencies (8.0 to 14.0 kHz). Group differences at high frequencies were statistically significant ( p ≤ 0.001). Additionally, significantly lower TEOAE ( p = 0.009) and DPOAE ( p < 0.001) amplitudes were observed in the MoM patients when the better ear was included in the analysis, and more absent TEOAE and DPOAE responses were found between 1.0 and 4.0 kHz (0.008 ≤ p ≤ 0.039). Within the vestibular test battery, the MoM patients showed longer N1 and P1 ocular vestibular evoked myogenic potentials latencies for the left ear, and lower video head impulse test gains for the left anterior and right posterior semicircular canals (0.005 ≤ p ≤0.035). The patient-reported (questionnaire) outcome delivered no significant group differences ( p > 0.01). Six patients had elevated Co levels according to our local institutional threshold (>4 or 5 µg/l for unilateral or bilateral MoM hip implants, resp.), but their audiovestibular outcome measures did not differ significantly from those of the other patients. Corresponding to our preliminary investigations, the results indicate possibly Co-induced (predominantly high-frequency) auditory impairment, probably triggered by toxic damage to the cochlear structures. However, the low mean difference values, the lack of group differences for the patient-reported outcome measures, and the lack of any relationship with the blood Co levels strongly reduce the clinical relevance of these findings. Therefore, the risk of Co-induced ototoxic impairment is considered to be clinically negligible for the majority of MoM hip implant patients, and the use of auditory tests in the risk estimation of systemic Co toxicity should be decided on a case-by-case basis.

Metal-on-Metal hip prostheses lubrication analysis for Newtonian elastohydrodynamic fluid

The work focus on critical issues related to wear of artificial hip implants. Finite Element Method based simulation approach is developed for MoM (Metal-on-Metal) artificial hip implants performance study. The development of FEM model is used to identify the factors that are responsible for wear or damage in the MoM hip implants. The analysis describes the nonlinear behavior of lubricants for textured surfaces geometry. The nominal fluid-film thickness equations are used for journal bearing having non-recessed type configurations and restrictor flow mathematical evaluation. The solution of unknown fluid film pressure field is obtained in this work by solving the modified Reynolds equation along with restrictor flow equations with appropriate boundary conditions. This work is targeted towards the introduction of effective methods for reducing the wear in MoM hip implants. The results are generated at higher accuracy so that the performance can match with the realistic results.

Quantifying the bearing surface wear of retrieved hip replacements

Accurate quantification of bearing material loss from retrieved metal-on-metal (MOM) hip replacements is key to understanding their failure. Geometric methods are currently the only means of estimating volumetric wear from retrieved implants and numerous contrasting approaches to obtain these measures have been published. Data collection strategies have been thoroughly discussed and refined to minimise the effect of error incurring factors; however, there is an opportunity to optimise the current methods of estimating the pre-wear geometry and, therefore, improve the accuracy of wear volume measurements. An automated analysis strategy to quantify volumetric wear is proposed in this study, which utilises the entire bearing surface to determine the implants pristine geometry. This involves the iterative removal of geometrically effected data points to optimise the fit and size of a perfect sphere. Once fitted, this reference geometry is compared with the measured data, in its entirety, to calculate the volume change representative of the quantity of material lost. Improving the reliability of this parameter could influence the care of a million patients that remain with MOM hip implants. Rigorous validation of this method will dominate future work, ensuring that the accuracy and reliability of this approach are sufficient to provide clinically meaningful data.

Periprosthetic hypoxia as consequence of TRPM7 mediated cobalt influx in osteoblasts.

The reasons for the high number of loosened metal-on-metal (MoM) hip implants are still not fully understood. Hypoxia-inducible factor 1 (HIF-1) mediated signaling pathways, which normally modulate tissue metabolism under hypoxic circumstances, could be triggered by metallic wear debris and influence bone metabolism favoring osteolysis. This may lead to early loosening of the orthopedic implants. Immunhistochemical staining of periprosthetic tissues of failed artificial hip implants showed that the concentration of HIF-1α in the surrounding tissues of failed MoM hip implants was significantly higher in comparison to failed metal-on-polyethylene (MoP) hip implants and osteoarthritic tissues. Therefore, we examined the Co2+ -uptake mechanisms and the influence of Co2+ uptake on HIF-1α stabilization. Based on cobalt mediated quenching effects, calcium imaging experiments using fura-2 showed a concentration-dependent cobalt influx in MG-63 cells, which could be inhibited by the unspecific TRPM7 channel inhibitor 2-APB (20 μM) and TRPM7 specific siRNA. Western blots confirmed a dose dependent increase of HIF-1α upon stimulation with Co2+ . This effect could be abrogated by inhibition of cobalt influx using 2-APB. This study shows that chemical hypoxia originating from HIF-1α upregulation within the periprosthetic tissue is related to cobalt wear debris and highlights TRPM7 as an important key mediator in this context. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1806-1813, 2019.

Midterm risk of cancer with metal-on-metal hip replacements not increased in a Finnish population

Background and purpose — Metal-on-metal (MoM) total hip arthroplasty (THA) and hip resurfacing arthroplasty (HRA) have been widely used during the early 21st century. We assessed the midterm risk of cancer of patients treated with modern MoM hip implants compared with patients with non-MoM hip implants and the general Finnish population with special interest in soft tissue sarcomas and basalioma due to the findings of our previous report.Patients and methods — All large-diameter head MoM THAs and hip resurfacings performed in Finland between 2001 and 2010 were extracted from the Finnish Arthroplasty Register (10,728 patients). Patients who underwent conventional THA formed the non-MoM reference cohort (18,235 patients). Data on cancer cases up to 2014 were extracted from the Finnish Cancer Registry. The relative risk of cancer in the general population was expressed as the ratio of observed to expected number of cases, i.e., standardized incidence ratio (SIR). Poisson regression analysis was used to compare the cancer risk between the cohorts. The mean follow-up was 7.4 years (1–14) in the MoM cohort and 8.4 years (1–14) in the non-MoM cohort.Results — The overall risk of cancer in the MoM cohort was comparable to the general Finnish population (SIR 0.9, 95% CI 0.9–1.0). Risk of basalioma in the MoM cohort was higher than in the general Finnish population (SIR 1.2, CI 1.1–1.4) and higher than in the non-MoM cohort in the stratified regression analysis (RR 1.2, CI 1.0–1.4, p = 0.02). The SIR of soft-tissue sarcoma in the MoM cohort was 1.4 (CI 0.6–2.8); the incidence was same as in the non-MoM cohort.Interpretation — Metal-on-metal hip implants are not associated with an increased overall risk of cancer during midterm follow-up.

Gene expression in adverse reaction to metal debris around metal-on-metal arthroplasty: An RNA-Seq-based study

Joint replacement surgery is a standard treatment of advanced osteoarthritis (OA). Since 2000, cobalt-chromium (CoCr) metal-on-metal (MoM) implants were widely used in hip arthroplasties. Some patients developed “adverse reaction to metal debris” (ARMD) around the prosthesis, resulting in a need for revision surgery. In the present study, we addressed the pathogenesis of ARMD by genome-wide expression analysis.Pseudosynovial ARMD tissue was obtained from revision surgery of Articular Surface Replacement (ASR, DePuy, Warsaw, IN, USA) hip arthroplasties. Control tissue was 1) OA synovium from primary hip arthroplasties and 2) inflammatory pseudosynovial tissue from metal-on-plastic (MoP) implant revisions.In ARMD tissue, the expression of 1446 genes was significantly increased and that of 1881 decreased as compared to OA synovium. Genes associated with immune response, tissue development and certain leukocyte signaling pathways were enriched in the differently (FC > 2) expressed genes. The network analysis proposed PRKACB, CD2, CD52 and CD53 as the central regulators of the greatest (FC > 10) differences.When ARMD tissue was compared to MoP tissue, the expression of 16 genes was significantly higher and that of 21 lower. Many of these genes were associated with redox homeostasis, metal ion binding and transport, macrophage activation and apoptosis. Interestingly, genes central to myofibroblast (AEBP1 and DES) and osteoclast (CCL21, TREM2 and CKB) development were upregulated in the MoP tissue. In network analysis, IL8, NQO1, GSTT1 and HMOX1 were identified as potential central regulators of the changes.In conclusion, excessive amounts of CoCr debris produced by MoM hip implants induces in a group of patients a unique adverse reaction characterized with enhanced expression of genes associated with inflammation, redox homeostasis, metal ion binding and transport, macrophage activation and apoptosis.

Can zinc protect cells from the cytotoxic effects of cobalt ions and nanoparticles derived from metal-on-metal joint arthroplasties?

ObjectivesRecently, high failure rates of metal-on-metal (MOM) hip implants have raised concerns of cobalt toxicity. Adverse reactions occur to cobalt nanoparticles (CoNPs) and cobalt ions (Co2+) during wear of MOM hip implants, but the toxic mechanism is not clear.MethodsTo evaluate the protective effect of zinc ions (Zn2+), Balb/3T3 mouse fibroblast cells were pretreated with 50 μM Zn2+ for four hours. The cells were then exposed to different concentrations of CoNPs and Co2+ for four hours, 24 hours and 48 hours. The cell viabilities, reactive oxygen species (ROS) levels, and inflammatory cytokines were measured.ResultsCoNPs and Co2+ can induce the increase of ROS and inflammatory cytokines, such as tumour necrosis factor α (TNF-α), interleukin-1β (IL-1β) and interleukin-6 (IL-6). However, Zn pretreatment can significantly prevent cytotoxicity induced by CoNPs and Co2+, decrease ROS production, and decrease levels of inflammatory cytokines in Balb/3T3 mouse fibroblast cells.ConclusionThese results suggest that Zn pretreatment can provide protection against inflammation and cytotoxicity induced by CoNPs and Co2+ in Balb/3T3 cells.Cite this article: Y. Liu, H. Zhu, H. Hong, W. Wang, F. Liu. Can zinc protect cells from the cytotoxic effects of cobalt ions and nanoparticles derived from metal-on-metal joint arthroplasties? Bone Joint Res 2017;6:649–655. DOI: 10.1302/2046-3758.612.BJR-2016-0137.R2.

Cobalt toxicity in humans-A review of the potential sources and systemic health effects.

Cobalt (Co) and its compounds are widely distributed in nature and are part of numerous anthropogenic activities. Although cobalt has a biologically necessary role as metal constituent of vitamin B12, excessive exposure has been shown to induce various adverse health effects. This review provides an extended overview of the possible Co sources and related intake routes, the detection and quantification methods for Co intake and the interpretation thereof, and the reported health effects. The Co sources were allocated to four exposure settings: occupational, environmental, dietary and medical exposure. Oral intake of Co supplements and internal exposure through metal-on-metal (MoM) hip implants deliver the highest systemic Co concentrations. The systemic health effects are characterized by a complex clinical syndrome, mainly including neurological (e.g. hearing and visual impairment), cardiovascular and endocrine deficits. Recently, a biokinetic model has been proposed to characterize the dose-response relationship and effects of chronic exposure. According to the model, health effects are unlikely to occur at blood Co concentrations under 300μg/l (100μg/l respecting a safety factor of 3) in healthy individuals, hematological and endocrine dysfunctions are the primary health endpoints, and chronic exposure to acceptable doses is not expected to pose considerable health hazards. However, toxic reactions at lower doses have been described in several cases of malfunctioning MoM hip implants, which may be explained by certain underlying pathologies that increase the individual susceptibility for Co-induced systemic toxicity. This may be associated with a decrease in Co bound to serum proteins and an increase in free ionic Co2+. As the latter is believed to be the primary toxic form, monitoring of the free fraction of Co2+ might be advisable for future risk assessment. Furthermore, future research should focus on longitudinal studies in the clinical setting of MoM hip implant patients to further elucidate the dose-response discrepancies.

Characterization of wear debris from metal‐on‐metal hip implants during normal wear versus edge‐loading conditions

Advantages of second-generation metal-on-metal (MoM) hip implants include low volumetric wear rates and the release of nanosized wear particles that are chemically inert and readily cleared from local tissue. In some patients, edge loading conditions occur, which result in higher volumetric wear. The objective of this study was to characterize the size, morphology, and chemistry of wear particles released from MoM hip implants during normal (40° angle) and edge-loading (65° angle with microseparation) conditions. The mean primary particle size by volume under normal wear was 35 nm (range: 9-152 nm) compared with 95 nm (range: 6-573 nm) under edge-loading conditions. Hydrodynamic diameter analysis by volume showed that particles from normal wear were in the nano- (<100 nm) to submicron (<1000 nm) size range, whereas edge-loading conditions generated particles that ranged from <100 nm up to 3000-6000 nm in size. Particles isolated from normal wear were primarily chromium (98.5%) and round to oval in shape. Edge-loading conditions generated more elongated particles (4.5%) (aspect ratio ≥ 2.5) and more CoCr alloy particles (9.3%) compared with normal wear conditions (1.3% CoCr particles). By total mass, edge-loading particles contained approximately 640-fold more cobalt than normal wear particles. Our findings suggest that high wear conditions are a potential risk factor for adverse local tissue effects in MoM patients who experience edge loading. This study is the first to characterize both the physical and chemical characteristics of MoM wear particles collected under normal and edge-loading conditions. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 986-996, 2018.

Halo and spillover effect illustrations for selected beneficial medical devices and drugs.

BackgroundNegative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a ‘negative halo effect,’ a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a ‘negative halo effect’ may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1) intrauterine contraceptive devices (IUDs); 2) silicone gel-filled breast implants (SGBI); 3) metal-on-metal hip implants (MoM); and 4) the drug Tysabri.MethodsData on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events.ResultsWe found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product’s safety reputation and prevalent use may take decades in the U.S., even while these products may exhibit widespread use and good safety records in other countries.ConclusionsWe conclude that the ‘negative halo effect’ associated with a stigma, rather than an objective risk-benefit assessment of medical products can increase negative health outcomes for patients due to reduced or inappropriate product usage.

Blood metal ion levels are not a useful test for adverse reactions to metal debris: A systematic review and meta-analysis.

ObjectivesAlarm over the reported high failure rates for metal-on-metal (MoM) hip implants as well as their potential for locally aggressive Adverse Reactions to Metal Debris (ARMDs) has prompted government agencies, internationally, to recommend the monitoring of patients with MoM hip implants. Some have advised that a blood ion level >7 µg/L indicates potential for ARMDs. We report a systematic review and meta-analysis of the performance of metal ion testing for ARMDs.MethodsWe searched MEDLINE and EMBASE to identify articles from which it was possible to reconstruct a 2 × 2 table. Two readers independently reviewed all articles and extracted data using explicit criteria. We computed a summary receiver operating curve using a Bayesian random-effects hierarchical model.ResultsOur literature search returned 575 unique articles; only six met inclusion criteria defined a priori. The discriminative capacity of ion tests was homogeneous across studies but that there was substantial cut-point heterogeneity. Our best estimate of the “true” area under curve (AUC) for metal ion testing is 0.615, with a 95% credible interval of 0.480 to 0.735, thus we can state that the probability that metal ion testing is actually clinically useful with an AUC ≥ 0.75 is 1.7%.ConclusionMetal ion levels are not useful as a screening test for identifying high risk patients because ion testing will either lead to a large burden of false positive patients, or otherwise marginally modify the pre-test probability. With the availability of more accurate non-invasive tests, we did not find any evidence for using blood ion levels to diagnose symptomatic patients.Cite this article: M. Pahuta, J. M. Smolders, J. L. van Susante, J. Peck, P. R. Kim, P. E. Beaule. Blood metal ion levels are not a useful test for adverse reactions to metal debris: a systematic review and meta-analysis. Bone Joint Res 2016;5:379–386. DOI: 10.1302/2046-3758.59.BJR-2016-0027.R1.

A preliminary evaluation of immune stimulation following exposure to metal particles and ions using the mouse popliteal lymph node assay

The objective of this preliminary study was to evaluate the threshold for immune stimulation in mice following local exposure to metal particles and ions representative of normal-functioning cobalt-chromium (CoCr) metal-on-metal (MoM) hip implants. The popliteal lymph node assay (PLNA) was used in this study to assess immune responses in BALB/c mice following treatment with chromium-oxide (Cr2O3) particles, metal salts (CoCl2, CrCl3 and NiCl2), or Cr2O3 particles together with metal salts using single-dose exposures representing approximately 10days (0.000114mg), 19years (0.0800mg), and 40years (0.171mg) of normal implant wear. The immune response elicited following treatment with Cr2O3 particles together with metal salts was also assessed at four additional doses equivalent to approximately 1.5months (0.0005mg), 0.6years (0.0025mg), 2.3years (0.01mg), and 9.3years (0.04mg) of normal implant wear. Mice were injected subcutaneously (50μL) into the right hind foot with the test article, or with the relevant vehicle control. The proliferative response of the draining lymph node cells (LNC) was measured four days after treatment, and stimulation indices (SI) were derived relative to vehicle controls. The PLNA was negative (SI<3) for all Cr2O3 particle doses, and was also negative at the lowest dose of the metal salt mixture, and the lowest four doses of the Cr2O3 particles with metal salt mixture. The PLNA was positive (SI>3) at the highest two doses of the metal salt mixture and the highest three doses of the Cr2O3 particles with the metal salt mixture. The provisional NOAEL and LOAEL values identified in this study for immune activation corresponds to Co and Cr concentrations in the synovial fluid approximately 500 and 2000 times higher than that reported for normal-functioning MoM hip implants, respectively. Overall, these results indicate that normal wear conditions are unlikely to result in immune stimulation in individuals not previously sensitized to metals.

Management of metal-on-metal hip implant patients: Who, when and how to revise?

The debate on how best to manage patients with metal-on-metal (MOM) hip implants continues. With over 1 million patients affected worldwide, the impact is far reaching. The majority of the aggressive failures of MOM hip implants have been dealt with by revision hip surgery, leaving patients with a much more indolent pattern of failure of devices that have been in situ for more than 10 years. The longer-term outcome for such patients remains unknown, and much debate exists on how best to manage these patients. Regulatory guidance is available but remains open to interpretation due to the lack of current evidence and long-term studies. Metal ion thresholds for concern have been suggested at 7 ppb for hip resurfacing arthroplasty and below this level for large diameter total hip arthroplasties. Soft tissue changes including pseudotumours and muscle atrophy have been shown to progress, but this is not consistent. New advanced imaging techniques are helping to diagnose complications with metal hips and the reasons for failure, however these are not widely available. This has led to some centres to tackle difficult cases through multidisciplinary collaboration, for both surgical management decisions and also follow-up decisions. We summarise current evidence and consider who is at risk, when revision should be undertaken and how patients should be managed.

In Vitro Analyses of the Toxicity, Immunological, and Gene Expression Effects of Cobalt-Chromium Alloy Wear Debris and Co Ions Derived from Metal-on-Metal Hip Implants

Joint replacement has proven to be an extremely successful and cost-effective means of relieving arthritic pain and improving quality of life for recipients. Wear debris-induced osteolysis is, however, a major limitation and causes orthopaedic implant aseptic loosening, and various cell types including macrophages, monocytes, osteoblasts, and osteoclasts, are involved. During the last few years, there has been increasing concern about metal-on-metal (MoM) hip replacements regarding adverse reactions to metal debris associated with the MoM articulation. Even though MoM-bearing technology was initially aimed to extend the durability of hip replacements and to reduce the requirement for revision, they have been reported to release at least three times more cobalt and chromium ions than metal-on-polyethylene (MoP) hip replacements. As a result, the toxicity of metal particles and ions produced by bearing surfaces, both locally in the periprosthetic space and systemically, became a concern. Several investigations have been carried out to understand the mechanisms responsible for the adverse response to metal wear debris. This review aims at summarising in vitro analyses of the toxicity, immunological, and gene expression effects of cobalt ions and wear debris derived from MoM hip implants.

CORR Insights(®): Revision of Metal-on-metal Hip Prostheses Results in Marked Reduction of Blood Cobalt and Chromium Ion Concentrations.

A limited number of relatively small studies are available detailing the outcome of hip revision surgeries after metal-on-metal (MoM) resurfacing hip arthroplasty or THA. General recommendations and opinions issued by national and international notifying bodies [3] and scientific committees throughout the world [2] frequently orient towards the individual benefit-to-risk ratio in guiding the decision of an orthopaedic surgeon who treats a particular patient. But the uncertainty and the scarcely available evidence limit the capacity of orthopaedic surgeons to appropriately decide on the management of patients with revised MoM hip implants. This is why the analysis of a large series is so important at the current state of knowledge. With this in mind, Lainiala et al. [1] studied 215 revised hips in 198 patients and confirmed that whole blood ion levels of cobalt decreased under the widely-used seven parts per billion threshold in unilateral cases after revision. This was not confirmed in a few patients for blood ion levels of chromium (Cr), where the revision procedure is not entirely effective to relieve some patients from this metal ion. Similarly, pain clearly decreased after revision surgery. However, at 1-year followup, pain was still present in 16% of patients with unilateral, revised THA, and also in 27% of patients who underwent a unilateral revised resurfacing hip arthroplasty [1]. These data support the need for careful followup of revised patients, especially those with high Cr ions in blood and those reporting pain.

Muscle atrophy and metal-on-metal hip implants

Background and purpose — Muscle atrophy is seen in patients with metal-on-metal (MOM) hip implants, probably because of inflammatory destruction of the musculo-tendon junction. However, like pseudotumors, it is unclear when atrophy occurs and whether it progresses with time. Our objective was to determine whether muscle atrophy associated with MOM hip implants progresses with time. Patients and methods — We retrospectively reviewed 74 hips in 56 patients (32 of them women) using serial MRI. Median age was 59 (23–83) years. The median time post-implantation was 83 (35–142) months, and the median interval between scans was 11 months. Hip muscles were scored using the Pfirrmann system. The mean scores for muscle atrophy were compared between the first and second MRI scans. Blood cobalt and chromium concentrations were determined. Results — The median blood cobalt was 6.84 (0.24–90) ppb and median chromium level was 4.42 (0.20–45) ppb. The median Oxford hip score was 34 (5–48). The change in the gluteus minimus mean atrophy score between first and second MRI was 0.12 (p = 0.002). Mean change in the gluteus medius posterior portion (unaffected by surgical approach) was 0.08 (p = 0.01) and mean change in the inferior portion was 0.10 (p = 0.05). Mean pseudotumor grade increased by 0.18 (p = 0.02). Interpretation — Worsening muscle atrophy and worsening pseudotumor grade occur over a 1-year period in a substantial proportion of patients with MOM hip implants. Serial MRI helps to identify those patients who are at risk of developing worsening soft-tissue pathology. These patients should be considered for revision surgery before irreversible muscle destruction occurs.

The relationship between the number of modularities and serum ions across different designs of metal on metal hip arthroplasty

s / International Journal of Surgery 12 (2014) S13eS117 S61 Results: The mechanism of injury was either due to a rugby tackle or fall from a bicycle. The majority of our cohort was male 86% with mean age 38 at time of surgery. All patients received physiotherapy sessions and been followed for 3-6 months. Post-operatively there were no significant difference in mean CC between operated and normal contralateral side. (12.2 vs 11.9 mm) (P<0.5). The median of quick DASH and ASES scores were 15.9 & 79.99 respectively. All the patients were satisfied with no complications recorded. Conclusions: Arthroscopic dog bone tight rope fixation of the ACJ is showing significant promise with minimal scarring and promising functional outcomes, good radiological outcomes, short post-operative stays and a low rate of complications. 0727: THE RELATIONSHIP BETWEEN THE NUMBER OF MODULARITIES AND SERUM IONS ACROSS DIFFERENT DESIGNS OF METAL ON METAL HIP ARTHROPLASTY Samer Mahmoud , Salam Ismael , Ibrahim Malek , D. woodnut , Alun Jones , Steve Jones . Royal National Orthopaedic Hospital, London, UK; University Hospital of Wales, Cardiff, UK; Morriston Hospital, Swansea, UK; 4 St George Hospital, London, UK. Introduction: To assess the relationship between serum ion levels and modularity across different metal on metal (MOM) arthroplasty designs. Methods: A cohort of 616 metal on metal hip replacement patients with similar bearing materials divided based on modularity design (number of articulating surfaces) into 4 groups: resurfacing BHR, Midhead replacements BMHR, Non-cemented stem MOM Hip replacement and the R3 with 3 bearing surfaces (115, 108, 355 and 38 patients respectively). Serum Cobalt and Chromium levels were assessed for each group and multivariant analysis used to create a regression model. Results: Mean time between the procedures and the blood results for the BHR, BMHR, non-cemented stem THR and R3 groups were 40, 35.5, 41.7 and 36.6 months respectively. After adjusting for other potential confounders like head size and gender there was liner relationship between number of articulations and S. Cobalt with positive coefficient values started from 0.25 in BMHR to 0.4 in R3 (P value<0.000:R21⁄411.65). Gender is a positive influence factor, which increases relationship linearity across all designs (P value<0.000:R21⁄413) S. Chromium did not fit the regression model as S. cobalt. Conclusions: There is statistically significant positive proportional relationship between increasedmodularity of MOM hip implants and S. Cobalt accumulation in patients' blood samples. 0731: GETTING TO GRIPS WITH THE BEST PRACTICE TARIFF FOR NECK OF FEMUR FRACTURES, EXPERIENCES FROM A MAJOR TRAUMA CENTRE: A COMPLETED AUDIT LOOP Iain Rankin , Amy Bibby, Reza Jenabzadeh, Dylan Griffiths, Rajarshi Bhattacharya. Department of Trauma and Orthopaedics, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK. Introduction: The Best Practice Tariff (BPT) introduced in 2010 aims to financially incentivize hospitals to optimize management of patients with neck of femur (NOF) fractures, utilizing a multidisciplinary approach against set criteria. Major Trauma Centres face challenges in the prioritisation of major trauma patients against fractured NOF patients. This audit examined compliance at a regional Major Trauma Centre, managing acute admissions in conjunction with transfers from a second site within the same trust, prior to and following implementation of a NOF Action Group. Methods: A retrospective audit of our compliance to BPT was conducted for the months of April December 2012, repeated January September 2013 following implementation of a NOF Action Group aimed to improve workflow. Results: 237 patients in 2012 and 236 patients in 2013 were eligible for BPT. Implementation of a NOFAction Group improved outcomes: BPT in all criteria increased from 46.8% to 71.2%; (p<0.001), with the most notable improvement in the rates for time to theatre <36 hours 57.6% to 80.5% (p<0.001). The financial implications were an estimated additional £77,235 for the trust. Conclusions: Implementation of a NOF Action Group improves compliance with BPT in a Major Trauma Centre, despite the challenges faced. 0739: THE ROLE OF EXOGEN IN NON-UNIONS, DOES IT SHOW ANY CLINICAL BENEFIT IN A LARGE DISTRICT GENERAL HOSPITAL? Nader Ibrahim , Devendra Mahadevan, Ramanathan Natarajan, James Rudd, William Groom. Northampton General Hospital, Northampton,

Contact mechanics studies of an ellipsoidal contact bearing surface of metal-on-metal hip prostheses under micro-lateralization

The morphology of the contact bearing surfaces plays an important role in the contact mechanics and potential wear of metal-on-metal (MOM) hip prostheses. An ellipsoidal bearing surface was proposed for MOM hip implants and the corresponding contact mechanics were studied by using the finite element method (FEM) under both standard and micro-lateralization conditions. When under micro-lateralization, the maximum contact pressure decreased from 927.3MPa to 203.0MPa, with increased ellipticity ratio medial-laterally. And the contact region was found to shift from the rim of the cup to the inner region compared to the spherical design. Under standard conditions, an increasing trend of the maximum contact pressure for the acetabular component was predicted as the major radius of the ellipsoidal bearing surface was increased. Nevertheless, the maximum contact pressure reached an asymptotic value when the ellipticity ratio was increased to 1.04. Therefore it is critical to optimize the ellipticity ratio in order to reduce the contact pressure under micro-lateralization condition and yet not to cause a markedly increased contact pressure under normal condition. Additionally, the maximum contact pressure in the ellipsoidal bearing surface remained relatively constant with the increased micro-lateralization. It is concluded that an ellipsoidal bearing surface morphology may be a promising alternative by offering better contact mechanisms when micro-lateralization should occur and attributing to minimized wear.

Nationwide investigation into adverse tissue reactions to metal debris after metal-on-metal total hip arthroplasty in Japan

BackgroundAdverse reactions to metal debris (ARMD) after receiving metal-on-metal (MoM) hip implants is a recent concern. However, no epidemiologic study has examined ARMD for MoM hip implants in Japan. The purposes of this study were to research the incidence of ARMD and to identify poorly performing MoM hip implants in Japan. MethodsFrom 2000 to 2011, 7 companies provided 23,226 MoM implants in Japan. A questionnaire regarding ARMD was sent to 101 hospitals at which 62 % of the 23,226 MoM implants had been used. ResultsReplies to the questionnaire were received from 82 hospitals. In these hospitals, surface hip replacement types (SRs) were used in 606 hips and stemmed types were used in 12,961 hips. ARMD were reported in 3 hips (0.5 %) with SRs and 160 hips (1.2 %) with stemmed types. ARMD in the 3 hips with SRs were asymptomatic and no revisions were performed. Among AMRD with stemmed implants, revision was performed in 83 hips and excision of an ARMD lesion was performed in 3 hips. The remaining 74 hips were asymptomatic and careful followup was continued. A significant difference in reoperation rate was evident between SRs (0 %) and stemmed types (0.7 %). Incidences of ARMD were significantly higher with Ultamet (P = 0.005), Conserve (P < 0.001), and Cormet (P < 0.001) MoM bearing couples than with Metasul bearings.

Outpatient toxicology clinic experience of patients with hip implants

Context. With regard to biological effects, the increasing number of early failure of metal-on-metal (MoM) hip arthroplasties and possible parenteral exposure to orthopedic metal alloys have caused concern for patients and providers alike. Objective. We sought to characterize our outpatient clinical experience of patients with MoM and other forms of hip implants and associated serum/blood chromium and cobalt levels, with a focus on possible systemic sequelae. Methods. This was an observational and retrospective chart review of consecutive patients presenting to two outpatient medical toxicology clinics from January 1, 2010-June 1, 2012 with history of hip implants. Presenting signs, symptoms, and interventions were reviewed. Available cobalt and chromium levels were summarized as median concentration with interquartile range. Results. A total of 39 patients were analyzed; of the 39 patients, 26 had MoM hip implants while 13 did not. Twelve patients exhibited no symptoms and nine sought evaluation for fatigue while two other patients had been previously diagnosed with fibromyalgia. Tinnitus/hearing loss was also a frequent complaint noted in 12 patients (one presenting complaint), however there was no difference between the incidence of this symptom between the MoM and non-MoM groups. Three patients were provisionally diagnosed with demyelinating neuropathy with one patient demonstrating marked (subjective and objective) improvement after revision. Patients with MoM arthroplasties generally exhibit an approximately tenfold increase in metal ion levels than traditional arthroplasties. Finally, 20 (51.2%) patients had replacement or revision of their hip implant with subsequent decreases in metal ion levels. Discussion. A majority of our patients had minor symptoms (fatigue and muscle aches) or no symptoms (n = 23 or 59%). Documented peripheral neurotoxicity is uncommon. The decision for hip revision solely for toxicologic reasons is rare and usually involves a multidisciplinary approach. Conclusion. Most patients seeking toxicologic referral may be minimally symptomatic and seek guidance regarding elevated blood or serum metal ions; however, solely toxicologic-based interventions are unusual. Revision was associated with a decrease in metal ion levels; however, subjective complaints did not correlate with metal ion levels.