Adverse Reaction To Metal Debris Research Articles

Taper Corrosion in Modular Hip Prostheses: Analysis of Serum Metal Ions in 19 Patients

Recently, concerns have been raised about the use of metal-on-metal (MoM) implants. This has led to the recall of several resurfacing and large-diameter total hip arthroplasties (THA). Any MoM interface can be the cause of metal debris and adverse tissue reactions. We analyzed serum metal ions and HOOS scores in 19 of 306 patients treated with a THA with modular neck section. The only MoM interface in this particular implant is the taper between the neck and the stem. The articulating surface consists of a ceramic-on-polyethylene or ceramic-on-ceramic interface. As such, this study looks at the metal ion production from the modular neck section. One of 306 implants needed revision at 52-month follow-up because of an adverse reaction to metal debris (ARMD).

The clinical implications of elevated blood metal ion concentrations in asymptomatic patients with MoM hip resurfacings: a cohort study

ObjectiveTo determine whether elevated blood cobalt (Co) concentrations are associated with early failure of metal-on-metal (MoM) hip resurfacings secondary to adverse reaction to metal debris (ARMD).DesignCohort study.SettingSingle centre orthopaedic unit.ParticipantsFollowing...

A Review of Hip Resurfacings Revised for Unexplained Pain

Adverse reaction to metal debris (ARMD) has come to prominence as a mode of failure for metal-on-metal hip resurfacings. These patients frequently present with unexplained groin pain. 1) To review all metal-on-metal hip resurfacings revised for unexplained pain seeking evidence for ARMD; 2) To determine the clinical outcome following revision arthroplasty. The hospital database was searched (1997-2009) to identify all cases of Birmingham Hip Resurfacings (BHRs) revised for unexplained pain. ARMD was diagnosed using specific clinical, radiological, and histopathological criteria. Postoperatively all patients were assessed in clinic and completed an Oxford Hip Score (OHS) questionnaire. Of 3076 BHRs implanted 149 were revised. Of these, 20 BHRs in 17 patients were revised for unexplained pain (mean age at BHR 50.5 yr; 55% female). Unexplained pain requiring revision had a prevalence of 0.65% of all hip resurfacings performed (20/3076). ARMD was the mode of failure in 50% (n = 10). Common features observed in ARMD patients included hip-joint effusions, femoral neck thinning, intraoperative macroscopic granulomas, and lymphocytic infiltrates on histopathological examination. No ARMD patients had macroscopic soft-tissue destruction. A range of mechanical causes were responsible for the remaining failures. At a mean 3.6 year follow-up (range 1.1-8.0) one ARMD patient experienced a dislocation. There were no further complications or need for surgical re-intervention. Median OHS for the cohort was 25.0%. Hip resurfacings revised for unexplained pain comprise a diverse group of conditions with ARMD being the commonest. ARMD probably contains subgroups yet to be defined, some of which may be related to mechanical rather than immunological factors.

Early Failures in Large Head Metal-On-Metal Total Hip Arthroplasty

Concerns have recently been raised about large head metal-on-metal total hip arthroplasties (LDH THA). Metal ion release due to wear may cause osteolysis, pseudotumours and necrosis. In addition, fixation of certain acetabular components is thought to be suboptimal. We present the short term outcome of the Durom LDH THA. Retrospectively, a consecutive series of 64 implants in 60 patients was analysed with a mean follow-up of 37 months. Clinical and radiological evaluation was performed on a regular basis, followed by additional evaluations when indicated. The 10-year revision percentage was calculated and compared with National Institute for Health and Clinical Excellence (NICE) standards. Six patients (six hips) underwent cup revision (9%). Four of these cups showed no or minimal bone fixation. Three patients had a pseudotumour. In two revision cases, ALVAL (aseptic lymphocyte-dominated vasculitis-associated lesion) was present. Lack of bone ingrowth and the presence of ARMD (adverse reaction to metal debris) seem to contribute to a high failure rate of the Durom LDH THA. The predicted ten-year revision rate of 14.2% (95% CI 5.6-22.8) is, given the broad confidence interval, not significantly outside NICE recommended standards. However, it is not clear which factors, if any, predict implant failure. Therefore, we do not advocate the use of this implant.

The Withdrawn ASR™ THA and Hip Resurfacing Systems: How Have Our Patients Fared Over 1 to 6 Years?

The Articular Surface Replacement™ (ASR™) metal-on-metal hip arthroplasty system (DePuy Orthopaedics, Inc, Warsaw, IN, USA) reportedly has a higher than anticipated early failure rate leading to a voluntary recall. This prompted us to evaluate all ASR™ components implanted at our center. In all ASR™ components, we reported (1) revision rate, (2) blood metal ion levels, and (3) intraoperative findings for revisions related to adverse reaction to metal debris (ARMD). We retrospectively reviewed all 172 patients (190 hips) who underwent THA (149 hips) or hip resurfacing (41 hips) with the ASR™ system. We determined failure rates. We obtained blood metal ion concentrations from 93 patients at last followup. We evaluated MRI studies and intraoperative histopathology. Minimum followup was 12months (mean, 40months; range, 12-74months). At latest followup, we had revised 24 of 190 hips (13%): in 18 patients with THA and five patients with resurfacing. Mean time to revision was 45months (range, 12-75months). Mean blood concentrations were 13μg/L (range, 0-150μg/L) for cobalt and 6μg/L (range, 0-87μg/L) for chromium. Mean prerevision blood metal ion levels were higher in the revised group (cobalt: 48μg/L; chromium: 18μg/L) than in the nonrevised group (cobalt: 5μg/L; chromium: 2μg/L). ARMD was present in 14 of the 24 hips revised in this study. Surgeons must have a low threshold for concern for ARMD in patients with ASR™ systems. Blood metal ion levels and MRI can be used to evaluate patients with underperforming implants. Intraoperative histopathologic analysis and joint fluid cytology can help diagnose ARMD at the time of revision. Level III, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

The sensitivity, specificity and predictive values of raised plasma metal ion levels in the diagnosis of adverse reaction to metal debris in symptomatic patients with a metal-on-metal arthroplasty of the hip

Plasma levels of cobalt and chromium ions and Metal Artefact Reduction Sequence (MARS)-MRI scans were performed on patients with 209 consecutive, unilateral, symptomatic metal-on-metal (MoM) hip arthroplasties. There was wide variation in plasma cobalt and chromium levels, and MARS-MRI scans were positive for adverse reaction to metal debris (ARMD) in 84 hips (40%). There was a significant difference in the median plasma cobalt and chromium levels between those with positive and negative MARS-MRI scans (p < 0.001). Compared with MARS-MRI as the potential reference standard for the diagnosis of ARMD, the sensitivity of metal ion analysis for cobalt or chromium with a cut-off of > 7 µg/l was 57%. The specificity was 65%, positive predictive value was 52% and the negative predictive value was 69% in symptomatic patients. A lowered threshold of > 3.5 µg/l for cobalt and chromium ion levels improved the sensitivity and negative predictive value to 86% and 74% but at the expense of specificity (27%) and positive predictive value (44%). Metal ion analysis is not recommended as a sole indirect screening test in the surveillance of symptomatic patients with a MoM arthroplasty. The investigating clinicians should have a low threshold for obtaining cross-sectional imaging in these patients, even in the presence of low plasma metal ion levels.

Metal Ion Levels Not Sufficient as a Screening Measure for Adverse Reactions in Metal-on-Metal Hip Arthroplasties

This study aims to assess the accuracy of metal ion analysis in the diagnosis of adverse reaction to metal debris (ARMD) in patients with metal-on-metal hip arthroplasties by comparing the cobalt and chromium levels in 57 patients (62 hips) to findings on metal artifact reduction magnetic resonance imaging (MRI). An ARMD was detected using MRI in 18 (29%) of the hips. Forty patients had cobalt levels less than 7 μg/L, and 33 had chromium levels less than 7 μg/L, but 8 of these had an ARMD on MRI and only minimal symptoms (Oxford Hip Score ≥44/48). The incidence of ARMD was significantly higher when chromium concentration was above 7 μg/L (P = .02), but normal metal ion levels can be misleading and metal artifact reduction MRI imaging is advised in all patients.

Adverse reactions to metal debris: histopathological features of periprosthetic soft tissue reactions seen in association with failed metal on metal hip arthroplasties

AimTo describe the histopathology of localised adverse reactions to metal debris (ARMD) seen in association with failed metal on metal (MoM) hip arthroplasties. The nature of aseptic lymphocytic vasculitis associated...

The Articular Surface Replacement Implant Recall: A United Kingdom District Hospital Experience

We present our experience of the articular surface replacement (ASR) hip and the implant recall process. One hundred and twenty-one ASR components were implanted (21 resurfacing hip arthroplasty (RHA) and 100 ASR/XL modular total hip replacements). At the time of the implant recall in August 2010 there were 111 surviving hips (92%) with a mean follow-up of 44 months. Nine hips had been revised and one had been listed for revision surgery. Ninety-two percent of surviving implants were reviewed in the recall clinics, and blood metal ion levels or ultrasound scans were indicated in 38 hips (34%). Immediately after the recall process seven hips (6 ASR/XL and 1 RHA) were listed for revision and a further 9 were kept under close surveillance. One year after completion of the recall process 23 hips (19 ASR/XL and 4 RHA's) had been revised. A diagnosis of adverse reaction to metal debris (ARMD) was made at surgery in all but two hips. Our current revision rate for ASR RHA is 19% (mean follow-up 62 months, range 29-80) and for the ASR/XL is 19% (mean follow-up 53 months, range 10-80). The 5-year cumulative survival rates with revision for any reason for the ASR/XL, was 80.8% (95% confidence interval 72.0 - 89.5). Given experience elsewhere we expect this rate may increase significantly with time.

The Effect of Obesity on Blood Metal Ion Levels after Hip Resurfacing and Metal-on-Metal Total Hip Replacement

There has been concern regarding potentially higher failure rates of metal-on-metal (MoM) bearings in obese patients, and possible adverse reaction to metal debris (ARMD). Elevated chromium (Cr) and cobalt (Co) levels in the blood indicate excess wear, and may predict secondary soft-tissue damage. We investigated the effect of obesity on blood Cr and Co levels in patients with MoM bearings. We reviewed data on 75 patients with hip resurfacing and MoM total hip arthroplasty (THA) at an average of 4 years follow-up. We excluded patients with factors that can affect metal ion levels including other metal implants, bilateral MoM bearings or during the 'running-in' phase. The patients were classified into two groups; obese (n=27) and control (n=48) depending on a body mass index (BMI) >= 30 kg/m2. There was no significant difference between the groups with regards to age, gender, renal function, cup inclination, implant type, femoral head size, time interval between operation and metal ion levels or the number of symptomatic patients. ?There was a trend for lower Cr and Co levels in the obese group but this was not statistically significant (p= 0.17 & 0.07, respectively). There was no correlation between the BMI and Cr or Co levels (Spearman's correlation coefficient r = - 0.13/p = 0.26 & - 0. 2/p = 0.1, respectively). There was no evidence of higher metal ion levels, suggestive of increased wear, in obese patients with MoM bearings.

Crowe Type I and II Ddh Managed by Large Diameter Metal-on-Metal Total Hip Arthroplasty

Large bearing metal-on-metal (MOM) total hip arthroplasty (THA) may offer advantages relating to stability and range of motion in patients with Crowe Type I and II developmental dysplasia of the hip (DDH). The purpose of this study was to provide an analysis of the clinical and radiological results of MOM THA in this context and compare the results with a cohort of patients treated with metal-on-polyethylene (MOP) bearing surfaces. 75 hips in 65 patients were treated with cementless MOM THA using large femoral heads (36-56 mm). The mean age of the patients was 47.4 years (29 to 59) and 54 were female. A group of 47 hips (41 patients) treated with conventional THA (screwed cup-polyethylene insert-28 mm head) was used for comparison. The study group was followed up for a mean of 62.1 months (32 to 76). No difference was found between the two groups in relation to improvement in Harris hip score (HHS) (43.1 to 90.3 points in the study group, 42.6 to 89.5 points in the control group, p>0.05). Although the preoperative range of motion in all planes were similar in both groups, the large head group demonstrated greater motion in all planes postoperatively, which was significant (all p=0.001). Additionally, there was a significant difference between groups in relation to the necessity for acetabular structural graft (8% and 31.9%, respectively; p=0.001). No major complications or adverse reactions to metal debris (ARMD) were observed in the study group. The results of large head MOM THA in young and active patients with DDH are similar to conventional THA at early follow-up, but the former offers the advantages of secure acetabular fixation without screws, greater range of motion, and lower risk of dislocation.

Adverse reaction to metal debris following hip resurfacing

We sought to establish the incidence of joint failure secondary to adverse reaction to metal debris (ARMD) following metal-on-metal hip resurfacing in a large, three surgeon, multicentre study involving 4226 hips with a follow-up of 10 to 142 months. Three implants were studied: the Articular Surface Replacement; the Birmingham Hip Resurfacing; and the Conserve Plus. Retrieved implants underwent analysis using a co-ordinate measuring machine to determine volumetric wear. There were 58 failures associated with ARMD. The median chromium and cobalt concentrations in the failed group were significantly higher than in the control group (p < 0.001). Survival analysis showed a failure rate in the patients with Articular Surface Replacement of 12.8% [corrected] at five years, compared with < 1% at five years for the Conserve Plus and 1.5% at ten years for the Birmingham Hip Resurfacing. Two ARMD patients had relatively low wear of the retrieved components. Increased wear from the metal-on-metal bearing surface was associated with an increased rate of failure secondary to ARMD. However, the extent of tissue destruction at revision surgery did not appear to be dose-related to the volumetric wear.