Category Archives: Metal Ions/Pseudotumors

Metal Ion/Pseudotumors Medical Studies

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Updated Guidelines To Monitor Metal on Metal Devices by UK’s MHRA 2017

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Original MEDICAL DEVICE ALERT by UK MHRA 2017 Available Here

The Medicines and Healthcare products Regulatory Agency (MHRA) UK has called for longer-term monitoring of all patients fitted with metal-on-metal hip implants, as a precautionary measure, in an update to its original guidance issued in 2012.

“MHRA, in colsultation with its independent Metal-on-Metal Expert Advisory Group (MoM EAG), has continued to monitor the performance of MoM hip joint articulations for the occurrence of soft tissue reaction associated with these devices. However, some patients will develop progressive soft tissue reactions to the wear debris associated with MoM articulations.”

Advice varies according to device, age and sex of patients.  The BHR is device with a 10A ODEP rating.  Those patients are recommended to have follow-ups and blood … Read the rest

Normal Levels of Cobalt and Chromium after Hip Resurfacing

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View Complete Study Here

Studies were searched for in the Medline database, Embase, and the Cochrane Database of Systematic Reviews. Highest mean or median ion concentrations of Cr and Co after a minimum of 1 year of follow-up were extracted and grouped according to sample- and articulation type, and average values were calculated…

…43 studies were included and 16 different MoM implants were identified. For the different types of bearings, average ion concentrations and range were calculated from the mean or median ion concentration. The average Cr concentration ranged between 0.5 and 2.5 μg/L in blood and between 0.8 and 5.1 μg/L in serum. For Co, the range was 0.7–3.4 μg/L in blood and 0.3–7.5 μg/L in serum…

Additional Information

The MHRA (medicines and healthcare … Read the rest

Guidelines to Follow-Up MOM Devices Not Cost Effective

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Original Article Here

A new study about adverse reactions to metal debris after Metal on Metal THR and Hip Resurfacing shows the current follow-up guidelines worldwide are not cost effective or evidence-based.

The follow-up guidelines for metal-on-metal (MoM) hip arthroplasty and hip resurfacing from five worldwide authorities worldwide, including the U.K. were included.

Findings showed large differences between cost per patients. U.S. costs were three-times more than MHRA costs…

…Australia vs. U.S. and Canada guidelines were about six-times more costly for asymptomatic patients.… Read the rest

Blood cobalt levels, device type may predict metal-on-metal hip failure study 2014

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

David J Langton, Raghavendra P Sidaginamale, Thomas J Joyce, Shonali Natu,
Peter Blain, Robert Drysdale Jefferson, Stephen Rushton, Antoni V F Nargol

Full Study Here
10.1136/
bmjopen-2012-001541
January 31, 2014

Objective:
To 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).

Design:
Cohort study.

Setting:
Single centre orthopaedic unit.

Participants:
Following the identification of complications potentially related to metal wear
debris, a blood metal ion screening programme was instigated at our unit in 2007
for all patients with Articular Surface Replacement (ASR) and Birmingham MoM hip
resurfacings. Patients were followed … Read the rest

Two-year Study of serum metal ion levels in hipresurfacing 2014

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Two-year serum metal ion levels in minimally invasive total conservative hip resurfacing: preliminary results of a prospective study Tai SM1, Millard N, Munir S, Jenabzadeh AR, Walter LR, Walter WL. Complete Study http://www.ncbi.nlm.nih.gov/pubmed/25288230 Metal-on-metal (MoM) hip resurfacings have been associated with the potential development of metallic debris and its associated pathology. Serum cobalt and chromium levels are a reliable surrogate marker of wear rates in MoM bearings. The aim of the study was to examine the trend in serum metal ion levels in the initial 2-year post-operative period following implantation of the minimally invasive total conservative hip MoM hip resurfacing and to determine whether head size, acetabular component orientation, clinical outcome scores or post-operative range of movement would affect these levels. METHODS: In this prospective… Read the rest

Metal ion release following hip replacement

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Metal ion release following hip replacement not strongly related to patient activity medical study

Metal ion release following hip replacement not strongly related to patient activity Read Complete Article by Clicking Here The amount of patient activity following metal-on-metal hip resurfacing arthroplasty seems to show little correlation to metal ion release, according to study presented here. Amir Kamali, PhD, presented his team’s findings at the 56th Annual Meeting of the Orthopedic Research Society.

Kamali reported that his group looked at 25 consecutive male patients who underwent a unilateral, 50-mm diameter metal-on-metal hip resurfacing… …”I should mention here that at 1, 2, and 4 years, the average metal ion levels were similar between these implants, meaning they had gone well into their steady state,” Kamali said…
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The effect of component size and metal ions after resurfacing arthroplasty

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The effect of component size and orientation on the concentrations of metal ions after resurfacing arthroplasty of the hip 2008

Link Read Complete Article by Clicking Here

D. J. Langton, MRCS, Orthopaedic Research Register1; S. S. Jameson, MRCS, Specialist Registrar, Trauma and Orthopaedics1; T. J. Joyce, MSc, PhD, MA, BEng, Lecturer in Bioengineering2; J. Webb, MRCS, Specialist Registrar, Trauma and Orthopaedics1; and A. V. F. Nargol, FRCS(Tr & Orth), Consultant Orthopaedic Surgeon1 1 Joint Replacement Unit, University Hospital of North Tees, Hardwick, Stockton-on-Tees TS19 8PE, UK. 2 Newcastle University, Claremont Road, Newcastle upon Tyne NE1 7RU, UK.

Increased concentrations of metal ions after metal-on-metal resurfacing arthroplasty of the hip remain a concern. Although there has been no proven link to long-term health problems or early
… Read the rest

Soft Tissue Reactions to Metal-on-Metal Arthroplasty

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By Robert Trace September 17, 2009

MANCHESTER – Researchers here reported that adverse soft tissue reactions following metal-on-metal hip arthroplasty are typically due to increased wear of the bearing surfaces, and patients with smaller femoral heads may be particularly susceptible to these complications.

In an independent center study, David Langton, FRCS, and colleagues in the Joint Replacement Unit at the University Hospital of North Tees in Stockton, England, reviewed 155 Birmingham Hip resurfacings (BHR, Smith & Nephew) performed between 2002 and 2009 (mean follow-up, 60 months). They also studied 420 articular surface replacements (ASRs) and 75 total hip replacements using ASR XL implants (both DePuy Orthopaedics) with S-ROM stems (DePuy Orthopaedics) with a mean follow-up of 35 months…

…There were 17

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Risk Factors for Inflammatory Pseudotumour Formation Study

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Abstract: Risk factors for inflammatory pseudotumour formation following hip resurfacing Complete Study S. Glyn-Jones, MA, FRCS(Orth), DPhil, Senior Lecturer, Consultant Orthopaedic Surgeon1; H. Pandit, FRCS(Orth), Senior Clinical Fellow1; Y.-M. Kwon, FRCS(Orth), FRACS(Orth), Research Fellow1; H. Doll, MSc, DPhil, Senior Medical Statistician2; H. S. Gill, BEng, DPhil, University Lecturer in Orthopaedic Engineering1; and D. W. Murray, MD, FRCS(Orth), Consultant Orthopaedic Surgeon, Professor1 1 Department of Orthopaedics, Nuffield Orthopaedic Centre Rheumatology and Musculoskeletal Sciences 2 Department of Public Health University of Oxford, Windmill Lane, Headington, Oxford OX3 7LD, UK. Metal-on-metal hip resurfacing is commonly performed for osteoarthritis in young active patients. We have observed cystic or solid masses, which we have called inflammatory pseudotumours, arising around
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Distribution of Chromium and Cobalt Ions Resurfacing Hip Arthroplasty

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Leonard R. Walter MBBS(Syd), FRACS,
FAOrthA, Ed Marel MBBS(Syd), FRCS Ed (Orth),
FRACS, FAOrthAa,
Richard Harbury MBBS(Syd), FRACS, FAOrthAa
and Jenny Wearne RNaPeninsula Orthopaedics Research
Institute, DEE WHY NSW 2099, Australia

Received 28 November 2006;

accepted 7 July 2007

Abstract

The most appropriate blood fraction for the
measurement of metal ions in patients with
metal-on-metal implants is controversial. We
compared chromium (Cr) and cobalt (Co) ion
levels in 29 patients after unilateral hip
resurfacing with a size 54-mm femoral Birmingham
Hip Resurfacing Prosthesis (Smith and Nephew,
London, UK). All had well-functioning
arthroplasties between 5 and 59 months after
implantation. Ion levels were measured in serum,
plasma, red cells, and whole blood in each
patient. Our results indicate that only very

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Metal Ion Study 2002

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Medium Term Serum Cobalt and Chromium Levels in Patients with Metal-metal Resurfacing
NOTE: This paper was presented at the New Trends of Joint Reconstructive Surgery 2002 Meeting, comparing serum levels in a control group, conventional THR, McKee Farrar, MOM Hip Resurfacing, and MOM THR (Sulzer), which concluded that metal ion levels are higher at 1 year with a small diameter MOM THR (Sulzer) than with resurfacing. As the Sulzer device has been in use for over 15 years with no associated problems reported to date, this is further evidence that this is currently not an issue.
V Reddy MD† J Dorairajan MD† J Nevelos PhD* S Krikler PhD FRCS(Orth)†. † University Hospitals Coven try & Warwickshire NHS Trust * Corin Medical†
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The Influence of Head Diameter, Clearance, Cup Position, and Head Position on Wear Rates in Metal-on-Metal Resurfacing

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Presented at the 2nd Annual Total Hip Resurfacing Arthroplasty Course in LA Oct. 2008

 

By: John Fisher Co-Authors: Ian Leslie, Sophie Williams, Eileen Ingham, Graham Isaac Institute of Medical and Biological Engineering University of Leeds

Background: There are considerable variations in metal ion levels and metallic wear rates in patients with metal on metal resurfacing. In this in vitro study the effect of design variables of head diameter and bearing clearance and patient variables of cup and head position on metal ion levels and wear rates are were investigated. Methods: Hip joint simulator studies were carried out on size 39mm and size 55mm metal on metal resurfacing with the same design. Size 55mm diameter bearings with 110 micrometer diametrical clearance were compared to size

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ASR vs Birmingham Hip Resurfacing Metal Ions

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Blood metal ion concentrations after hip resurfacing arthroplasty

A COMPARATIVE STUDY OF ARTICULAR SURFACE REPLACEMENTAND BIRMINGHAM HIP RESURFACING ARTHROPLASTIES

Summary

There have been no large comparative studies of the blood levels of metal ions after implantation of commercially available hip resurfacing devices which have taken into account the effects of femoral size and inclination and anteversion of the acetabular component. We present the results in 90 patients with unilateral articular surface replacement (ASR) hip resurfacings (mean time to blood sampling 26 months) and70 patients with unilateral Birmingham Hip Resurfacing (BHR) implants (mean time 47 months).

The whole blood and serum chromium (Cr) and cobalt (Co) concentrations were inversely related to the size of the femoral component in both groups (p < 0.05). Cr and Co

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Metal Ions in Offspring after hip resurfacing

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Study of cobalt and chromium levels in offspring of patients with metal-on-metal hip implants 03/09/2010
“You Have Your MoM’s Ions” Study finds elevated levels of cobalt and chromium in offspring of patients with metal-on-metal hip implantsNEW ORLEANS, LA Hip replacement patients with metal-on-metal (MoM) implants (both the socket and hip ball are metal) pass metal ions to their infants during pregnancy, according to a new study presented today at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Data showed there is a correlation between cobalt and chromium levels in the mother and those in her infant at the time of delivery. “Although the affects of metal ions in maternal and fetal subjects are unknown, the fact that the placenta is
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Metal ion levels and revision rates in metal-on-metal hip resurfacing arthroplasty 2014

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Complete Study Here: http://www.ncbi.nlm.nih.gov/pubmed/24500833 Robinson PG1, Wilkinson AJ, Meek RM. April 2014 Abstract Metal-on-metal (MoM) bearings in hip surgery are related to increased blood levels of metal ions. The nature of the relationship between ion levels and failure is still not fully understood. This study compares three cohorts of patients, 120 patients in each cohort, treated with a hip resurfacing arthroplasty, grouped by brand and diameter of femoral component on average four years postoperatively: Birmingham Hip Resurfacing ≥50 mm, Durom resurfacing ≥50 mm and Durom resurfacing <50 mm. The median blood ion levels of cobalt and chromium were significantly lower in the cohort with the large Durom resurfacing than the other two cohorts (P<0.05). The large BHR and large Durom HRA had revision rates of… Read the rest

Second generation metal-on-metal hip implants associated with adverse reactions 2014

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Full Article Available Here January 9, 2014 Research into metal-on-metal hip arthroplasty has showed that success with the procedure is multifactorial. Some investigators have found it may be closely related to an exacting surgical technique and the right indications. In an article in a recent issue of Orthopaedics Today Europe, Japanese investigators discussed adverse reactions associated with second generation metal-on-metal hip implants and found 67% of the implants they revised were positioned outside of the safe zone.    … Read the rest