Aims. We investigated whether
Objectives. Alarm 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. Methods. We 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. Results. Our 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%. Conclusion. Metal 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.
Objectives. The aims of this piece of work were to: 1) record the background
concentrations of blood chromium (Cr) and cobalt (Co) concentrations
in a large group of subjects; 2) to compare blood/serum Cr and Co
concentrations with retrieved metal-on-metal (MoM) hip resurfacings;
3) to examine the distribution of Co and Cr in the serum and whole
blood of patients with MoM hip arthroplasties; and 4) to further
understand the partitioning of metal ions between the serum and
whole blood fractions. Methods. A total of 3042 blood samples donated to the local transfusion
centre were analysed to record Co and Cr concentrations. Also, 91
hip resurfacing devices from patients who had given pre-revision
blood/serum samples for metal ion analysis underwent volumetric
wear assessment using a coordinate measuring machine. Linear regression analysis
was carried out and receiver operating characteristic curves were
constructed to assess the reliability of metal ions to identify
abnormally wearing implants. The relationship between serum and
whole blood concentrations of Cr and Co in 1048 patients was analysed
using Bland-Altman charts. This relationship was further investigated
in an in vitro study during which human blood was
spiked with trivalent and hexavalent Cr, the serum then separated
and the fractions analysed. Results. Only one patient in the transfusion group was found to have a
blood Co >
2 µg/l. Blood/Serum Cr and Co concentrations were reliable
indicators of abnormal wear. Blood Co appeared to be the most useful
clinical test, with a concentration of 4.5 µg/l showing sensitivity
and specificity for the detection of abnormal wear of 94% and 95%, respectively.
Generated metal ions tended to fill the serum compartment preferentially in
vivo and this was replicated in the in vitro study
when blood was spiked with trivalent Cr and bivalent Co. Conclusions.
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) and 70 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 were more strongly influenced by the position of the acetabular component in the case of the ASR, with an increase in metal ions observed at inclinations >
45° and anteversion angles of <
10° and >
20°. These levels were only increased in the BHR group when the acetabular component was implanted with an inclination >
55°. A significant relationship was identified between the anteversion of the BHR acetabular component and the levels of Cr and Co (p <
0.05 for Co), with an increase observed at anteversion angles <
10° and >
20°. The median whole blood and serum Cr concentrations of the male ASR patients were significantly lower than those of the BHR men (p <
0.001). This indicates that reduced diametral clearance may equate to a reduction in metal ion concentrations in larger joints with satisfactory orientation of the acetabular component.
Aims. To determine whether there is any association between glomerular
filtration rate (GFR) and blood cobalt (Co) and chromium (Cr) levels
in patients with metal-on-metal (MoM) hip arthroplasty. Patients and Methods. We identified 179 patients with a unilateral 36 mm diameter head
as part of a stemmed Summit-Pinnacle MoM hip arthroplasty. GFR was
calculated using the Modification of Diet in Renal Disease formula. Results. Normal renal function (GFR ≥ 90 ml/min/1.73 m. 2. ) was
seen in 74 patients. Mild renal insufficiency (GFR 60 to 89 ml/min/1.73
m. 2. ) was seen in 90 patients and moderate renal insufficiency
(GFR 30 to 59 ml/min/1.73 m. 2. ) in 15. There was no statistical
difference in Co and Cr levels between patients with normal renal
function and those with mild or moderate renal insufficiency. No
correlation was seen between creatinine and
Aims. The purpose of this study was to compare two different types
of metal-on-metal (MoM) bearing for total hip arthroplasty (THA):
one with a large femoral head (38 mm to 52 mm) and the other with
a conventional femoral head (28 mm or 32 mm). We compared clinical
outcome,
This study compared component wear rates and pre-revision
Aims. To find out if there is an inverse association between estimated glomerular filtration rate (eGFR) and whole blood cobalt (Co) and chromium (Cr) levels in patients with metal-on-metal (MoM) hip arthroplasties and renal insufficiency, suggesting that renal insufficiency could cause accumulation of Co and Cr in blood. Methods. Out of 2,520 patients with 3,013 MoM hip arthroplasties, we identified 1,244 patients with whole blood Co, Cr, and creatinine measured within no more than a one-year interval. We analyzed the correlation of
Aims. Dual mobility (DM) implants have been shown to reduce the dislocation rate after total hip arthroplasty (THA), but there remain concerns about the use of cobalt chrome liners inserted into titanium shells. The aim of this study was to assess the clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) at mid-term follow-up in young, active patients receiving a modular DM THA. Methods. This was a prospective study involving patients aged < 65 years, with a BMI of < 35 kg/m. 2. , and University of California, Los Angeles activity score of > 6 who underwent primary THA with a modular cobalt chrome acetabular liner, highly cross-linked polyethylene mobile bearing, and a cementless titanium femoral stem. Patient-reported outcome measures, whole
Aims. The aim of this study was to evaluate
Aims. Modular dual mobility (DM) prostheses in which a cobalt-chromium liner is inserted into a titanium acetabular shell (vs a monoblock acetabular component) have the advantage of allowing supplementary screw fixation, but the potential for corrosion between the liner and acetabulum has raised concerns. While DM prostheses have shown improved stability in patients deemed ‘high-risk’ for dislocation undergoing total hip arthroplasty (THA), their performance in young, active patients has not been reported. This study’s purpose was to assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular DM acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design. Patients and Methods. This was a prospective study of patients between 18 and 65 years of age, with a body mass index (BMI) < 35 kg/m. 2. and University of California at Los Angeles (UCLA) activity score > 6, who received a modular cobalt-chromium acetabular liner, highly crosslinked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. A total of 43 patients (30 male, 13 female; mean age 52.6 years (. sd. 6.5)) were enrolled. All patients had a minimum of two years’ clinical follow-up. Patient-reported outcome measures, whole
The Articular Surface Replacement (ASR) hip resurfacing arthroplasty has a failure rate of 12.0% at five years, compared with 4.3% for the Birmingham Hip Resurfacing (BHR). We analysed 66 ASR and 64 BHR explanted metal-on-metal hip replacements with the aim of understanding their mechanisms of failure. We measured the linear wear rates of the acetabular and femoral components and analysed the clinical cause of failure, pre-revision
Objectives. The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces. Methods. In this study, a coordinate measuring machine (CMM) was used to measure the wear on five failed cementless Biomet Magnum/ReCap/ Taperloc large head MoM THAs, along with one Biomet ReCap resurfacing joint. Surface roughness measurements were also taken. The reason for revision of these implants was pain and/or adverse reaction to metal debris (ARMD) and/or elevated
We prospectively assessed the efficacy of a ceramic-on-metal
(CoM) hip bearing with uncemented acetabular and femoral components
in which cobalt–chrome acetabular liners and alumina ceramic heads
were used. The cohort comprised 94 total hip replacements (THRs) in 83 patients
(38 women and 45 men) with a mean age of 58 years (42 to 70). Minimum
follow-up was two years. All patients had pre- and post-operative
assessment using the Western Ontario and McMaster Universities osteoarthritis
index (WOMAC), Oxford hip score and Short-Form 12 scores. All showed
a statistically significant improvement from three months post-operatively
onwards (all p <
0.001). After two years whole
This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole
Objectives. This study aimed to characterise and qualitatively grade the severity of the corrosion particles released into the hip joint following taper corrosion. Methods. The 26 cases examined were CoC/ABG Modular (n = 13) and ASR/SROM (n = 13).
We carried out metal artefact-reduction MRI, three-dimensional CT measurement of the position of the component and inductively-coupled plasma mass spectrometry analysis of cobalt and chromium levels in whole blood on 26 patients with unexplained pain following metal-on-metal resurfacing arthroplasty. MRI showed periprosthetic lesions around 16 hips, with 14 collections of fluid and two soft-tissue masses. The lesions were seen in both men and women and in symptomatic and asymptomatic hips. Using three-dimensional CT, the median inclination of the acetabular component was found to be 55° and its positioning was outside the Lewinnek safe zone in 13 of 16 cases. Using inductively-coupled plasma mass spectrometry, the levels of
Head-taper corrosion is a cause of failure in total hip arthroplasty (THA). Recent reports have described an increasing number of V40 taper failures with adverse local tissue reaction (ALTR). However, the real incidence of V40 taper damage and its cause remain unknown. The aim of this study was to evaluate the long-term incidence of ALTR in a consecutive series of THAs using a V40 taper and identify potentially related factors. Between January 2006 and June 2007, a total of 121 patients underwent THA using either an uncemented (Accolade I, made of Ti12Mo6Zr2Fe; Stryker, USA) or a cemented (ABG II, made of cobalt-chrome-molybdenum (CoCrMo); Stryker) femoral component, both with a V40 taper (Stryker). Uncemented acetabular components (Trident; Stryker) with crosslinked polyethylene liners and CoCr femoral heads of 36 mm diameter were used in all patients. At a mean folllow-up of 10.8 years (SD 1.1), 94 patients (79%) were eligible for follow-up (six patients had already undergone a revision, 15 had died, and six were lost to follow-up). A total of 85 THAs in 80 patients (mean age 61 years (24 to 75); 47 (56%) were female) underwent clinical and radiological evaluation, including the measurement of whole blood levels of cobalt and chrome. Metal artifact reduction sequence MRI scans of the hip were performed in 71 patients.Aims
Methods
Large-diameter metal-on-metal (MoM) total hip arthroplasty (THA) has demonstrated unexpected high failure rates and pseudotumour formation. The purpose of this prospective cohort study is to report ten-year results in order to establish revision rate, prevalence of pseudotumour formation, and relation with whole blood cobalt levels. All patients were recalled according to the guidelines of the Dutch Orthopaedic Association. They underwent clinical and radiographical assessments (radiograph and CT scan) of the hip prosthesis and whole blood cobalt ion measurements. Overall, 94 patients (95 hips) fulfilled our requirements for a minimum ten-year follow-up.Aims
Methods
The Birmingham Hip Resurfacing (BHR) arthroplasty has been used as a surgical treatment of coxarthrosis since 1997. We present 20-year results of 234 consecutive BHRs performed in our unit. Between 1999 and 2001, there were 217 patients: 142 males (65.4%), mean age 52 years (18 to 68) who had 234 implants (17 bilateral). They had patient-reported outcome measures collected, imaging (radiograph and ultrasound), and serum metal ion assessment. Survivorship analysis was performed using Kaplan-Meier estimates. Revision for any cause was considered as an endpoint for the analysis.Aims
Methods
A recent report from France suggested an association between the use of cobalt-chrome (CoCr) femoral heads in total hip arthroplasties (THAs) and an increased risk of dilated cardiomyopathy and heart failure. CoCr is a commonly used material in orthopaedic implants. If the reported association is causal, the consequences would be significant given the millions of joint arthroplasties and other orthopaedic procedures in which CoCr is used annually. We examined whether CoCr-containing THAs were associated with an increased risk of all-cause mortality, heart outcomes, cancer, and neurodegenerative disorders in a large national database. Data from the National Joint Registry was linked to NHS English hospital inpatient episodes for 374,359 primary THAs with up to 14.5 years' follow-up. We excluded any patients with bilateral THAs, knee arthroplasties, indications other than osteoarthritis, aged under 55 years, and diagnosis of one or more outcome of interest before THA. Implants were grouped as either containing CoCr or not containing CoCr. The association between implant construct and the risk of all-cause mortality and incident heart failure, cancer, and neurodegenerative disorders was examined.Aims
Methods
The optimum clearance between the bearing surfaces of hip arthroplasties is unknown. Theoretically, to minimize wear, it is understood that clearances must be low enough to maintain optimal contact pressure and fluid film lubrication, while being large enough to allow lubricant recovery and reduce contact patch size. This study aimed to identify the relationship between diametrical clearance and volumetric wear, through the analysis of retrieved components. A total of 81 metal-on-metal Pinnacle hips paired with 12/14 stems were included in this study. Geometrical analysis was performed on each component, using coordinate and roundness measuring machines. The relationship between their as-manufactured diametrical clearance and volumetric wear was investigated. The Mann-Whitney U test and unpaired Aims
Methods
To establish the survivorship, function, and metal ion levels in an unselected series of metal-on-metal hip resurfacing arthroplasties (HRAs) performed by a non-designer surgeon. We reviewed 105 consecutive HRAs in 83 patients, performed by a single surgeon, at a mean follow-up of 14.9 years (9.3 to 19.1). The cohort included 45 male and 38 female patients, with a mean age of 49.5 years (SD 12.5)Aims
Methods
We have previously demonstrated raised cobalt and chromium levels in patients with larger diameter femoral heads, following metal-on-polyethylene uncemented total hip arthroplasty. Further data have been collected, to see whether these associations have altered with time and to determine the long-term implications for these patients and our practice. Patients from our previous study who underwent Trident-Accolade primary total hip arthroplasties using a metal-on-polyethylene bearing in 2009 were reviewed. Patients were invited to have their cobalt and chromium levels retested, and were provided an Oxford Hip Score. Serum ion levels were then compared between groups (28 mm, 36 mm, and 40 mm heads) and over time.Aims
Methods
Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event. A total of 92 retrieved MoM Pinnacle hips were analyzed, of which 45 were implanted before 2007, and 47 from 2007 onwards. The ‘pre-2007’ group contained 45 implants retrieved from 21 male and 24 female patients, with a median age of 61.3 years (interquartile range (IQR) 57.1 to 65.5); the ‘2007 onwards’ group contained 47 implants retrieved from 19 male and 28 female patients, with a median age of 61.8 years (IQR 58.5 to 67.8). The volume of material lost from their bearing and taper surfaces was measured using coordinate and roundness measuring machines. These outcomes were then compared statistically using linear regression models, adjusting for potentially confounding factors.Objectives
Methods
To determine ten-year failure rates following 36 mm metal-on-metal
(MoM) Pinnacle total hip arthroplasty (THA), and identify predictors
of failure. We retrospectively assessed a single-centre cohort of 569 primary
36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012
according to Medicines and Healthcare Products Regulation Agency
recommendations. All-cause failure rates (all-cause revision, and
non-revised cross-sectional imaging failures) were calculated, with predictors
for failure identified using multivariable Cox regression.Aims
Patients and Methods
The aim of this study was to assess the functional gain achieved following hip resurfacing arthroplasty (HRA). A total of 28 patients (23 male, five female; mean age, 56 years (25 to 73)) awaiting Birmingham HRA volunteered for this prospective gait study, with an age-matched control group of 26 healthy adults (16 male, ten female; mean age, 56 years (33 to 84)). The Oxford Hip Score (OHS) and gait analysis using an instrumented treadmill were used preoperatively and more than two years postoperatively to measure the functional change attributable to the intervention.Aims
Patients and Methods
T-cells are considered to play an important role in the inflammatory response causing arthroplasty failure. The study objectives were to investigate the composition and distribution of CD4+ T-cell phenotypes in the peripheral blood (PB) and synovial fluid (SF) of patients undergoing revision surgery for failed metal-on-metal (MoM) and metal-on-polyethylene (MoP) hip arthroplasties, and in patients awaiting total hip arthroplasty. In this prospective case-control study, PB and SF were obtained from 22 patients (23 hips) undergoing revision of MoM (n = 14) and MoP (n = 9) hip arthroplasties, with eight controls provided from primary hip osteoarthritis cases awaiting arthroplasty. Lymphocyte subtypes in samples were analysed using flow cytometry.Objectives
Methods
We conducted a retrospective study to assess
the prevalence of adverse reactions to metal debris (ARMD) in patients
operated on at our institution with metal-on-metal (MoM) total hip
replacements with 36 mm heads using a Pinnacle acetabular shell.
A total of 326 patients (150 males, 175 hips; 176 females, 203 hips)
with a mean age of 62.7 years (28 to 85) and mean follow-up of 7.5
years (0.1 to 10.8) participating in our in-depth modern MoM follow-up
programme were included in the study, which involved recording whole
blood cobalt and chromium ion measurements, Oxford hip scores (OHS)
and plain radiographs of the hip and targeted cross-sectional imaging. Elevated
blood metal ion levels (>
5 parts per billion) were seen in 32 (16.1%)
of the 199 patients who underwent unilateral replacement. At 23
months after the start of our modern MoM follow-up programme, 29
new cases of ARMD had been revealed. Hence, the nine-year survival
of this cohort declined from 96% (95% CI 95 to 98) with the old
surveillance routine to 86% (95% CI 82 to 90) following the new
protocol. Although ARMD may not be as common in 36 mm MoM THRs as
in those with larger heads, these results support the Medicines
and Healthcare Products Regulatory Agency guidelines on regular
reviews and further investigations, and emphasise the need for specific
a follow-up programme for patients with MoM THRs. Cite this article:
We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr. For part A, we included all revision surgeries carried out at our unit with the relevant data, including volumetric wear analysis, joint fluid (JF) Co and Cr concentrations, and ALVAL grade (n = 315). Receiver operating characteristic curves were constructed to assess the reliability of the CoCr JFR in identifying severe ALVAL and/or SOTP. For part B, we included only patients with unilateral prostheses who had given matched serum and whole blood samples for Co and Cr analysis (n = 155). Multiple regression was used to examine the influence of JF concentrations on the serum partitioning of Co and Cr in the blood.Objectives
Methods
Our first aim was to determine whether there are significant
changes in the level of metal ions in the blood at mid-term follow-up,
in patients with an Articular Surface Replacement (ASR) arthroplasty.
Secondly, we sought to identify risk factors for any increases. The study involved 435 patients who underwent unilateral, metal-on-metal
(MoM) hip resurfacing (HRA) or total hip arthroplasty (THA). These
patients all had one measurement of the level of metal ions in the
blood before seven years had passed post-operatively (early evaluation)
and one after seven years had passed post-operatively (mid-term evaluation).
Changes in ion levels were tested using a Wilcoxon signed-rank test.
We identified subgroups at the highest risk of increase using a
multivariable linear logistic regression model.Aims
Patients and Methods
Early failure associated with adverse reactions to metal debris is an emerging problem after hip resurfacing but the exact mechanism is unclear. We analysed our entire series of 660 metal-on-metal resurfacings (Articular Surface Replacement (ASR) and Birmingham Hip Resurfacing (BHR)) and large-bearing ASR total hip replacements, to establish associations with metal debris-related failures. Clinical and radiological outcomes, metal ion levels, explant studies and lymphocyte transformation tests were performed. A total of 17 patients (3.4%) were identified (all ASR bearings) with adverse reactions to metal debris, for which revision was required. This group had significantly smaller components, significantly higher acetabular component anteversion, and significantly higher whole concentrations of blood and joint chromium and cobalt ions than asymptomatic patients did (all p <
0.001). Post-revision lymphocyte transformation tests on this group showed no reactivity to chromium or cobalt ions. Explants from these revisions had greater surface wear than retrievals for uncomplicated fractures. The absence of adverse reactions to metal debris in patients with well-positioned implants usually implies high component wear. Surgeons must consider implant design, expected component size and acetabular component positioning in order to reduce early failures when performing large-bearing metal-on-metal hip resurfacing and replacement.
There are many guidelines that help direct the management of
patients with metal-on-metal (MOM) hip arthroplasties. We have undertaken
a study to compare the management of patients with MOM hip arthroplasties in
different countries. Six international tertiary referral orthopaedic centres were
invited to participate by organising a multi-disciplinary team (MDT)
meeting, consisting of two or more revision hip arthroplasty surgeons
and a musculoskeletal radiologist. A full clinical dataset including
history, blood tests and imaging for ten patients was sent to each
unit, for discussion and treatment planning. Differences in the
interpretation of findings, management decisions and rationale for
decisions were compared using quantitative and qualitative methods.Aims
Methods
Lately, concerns have arisen following the use of large metal-on-metal bearings in hip replacements owing to reports of catastrophic soft-tissue reactions resulting in implant failure and associated complications. This review examines the literature and contemporary presentations on current clinical dilemmas in metal-on-metal hip replacement.
The aim of this study was to determine whether the rates of revision
for metal-on-metal (MoM) total hip arthroplasties (THAs) with Pinnacle
components varied according to the year of the initial operation,
and compare these with the rates of revision for other designs of
MoM THA. Data from the National Joint Registry for England and Wales included
36 mm MoM THAs with Pinnacle acetabular components which were undertaken
between 2003 and 2012 with follow-up for at least five years (n
= 10 776) and a control group of other MoM THAs (n = 13 817). The
effect of the year of the primary operation on all-cause rates of revision
was assessed using Cox regression and interrupted time-series analysis.Aims
Patients and Methods
We undertook a retrospective cohort study to
determine clinical outcomes following the revision of metal-on-metal (MoM)
hip replacements for adverse reaction to metal debris (ARMD), and
to identify predictors of time to revision and outcomes following
revision. Between 1998 and 2012 a total of 64 MoM hips (mean age
at revision of 57.8 years; 46 (72%) female; 46 (72%) hip resurfacings
and 18 (28%) total hip replacements) were revised for ARMD at one specialist
centre. At a mean follow-up of 4.5 years (1.0 to 14.6) from revision
for ARMD there were 13 hips (20.3%) with post-operative complications
and eight (12.5%) requiring re-revision. The Kaplan–Meier five-year survival rate for ARMD revision was
87.9% (95% confidence interval 78.9 to 98.0; 19 hips at risk). Excluding
re-revisions, the median absolute Oxford hip score (OHS) following
ARMD revision using the percentage method (0% best outcome and 100%
worst outcome) was 18.8% (interquartile range (IQR) 7.8% to 48.3%),
which is equivalent to 39/48 (IQR 24.8/48 to 44.3/48) when using
the modified OHS. Histopathological response did not affect time
to revision for ARMD (p = 0.334) or the subsequent risk of re-revision
(p = 0.879). Similarly, the presence or absence of a contralateral
MoM hip bearing did not affect time to revision for ARMD (p = 0.066)
or the subsequent risk of re-revision (p = 0.178). Patients revised to MoM bearings had higher rates of re-revision
(five of 16 MoM hips re-revised; p = 0.046), but those not requiring
re-revision had good functional results (median absolute OHS 14.6%
or 41.0/48). Short-term morbidity following revision for ARMD was
comparable with previous reports. Caution should be exercised when choosing
bearing surfaces for ARMD revisions. Cite this article:
We investigated the changes seen on serial metal
artefact reduction magnetic resonance imaging scans (MARS-MRI) of
metal-on-metal total hip arthroplasties (MoM THAs). In total 155
THAs, in 35 male and 100 female patients (mean age 70.4 years, 42
to 91), underwent at least two MRI scans at a mean interval of 14.6
months (2.6 to 57.1), at a mean of 48.2 months (3.5 to 93.3) after
primary hip surgery. Scans were graded using a modification of the
Oxford classification. Progression of disease was defined as an
increase in grade or a minimum 10% increase in fluid lesion volume
at second scan. A total of 16 hips (30%) initially classified as
‘normal’ developed an abnormality on the second scan. Of those with
‘isolated trochanteric fluid’ 9 (47%) underwent disease progression,
as did 7 (58%) of ‘effusions’. A total of 54 (77%) of hips initially
classified as showing adverse reactions to metal debris (ARMD) progressed,
with higher rates of progression in higher grades. Disease progression
was associated with high blood cobalt levels or an irregular pseudocapsule
lining at the initial scan. There was no association with changes
in functional scores. Adverse reactions to metal debris in MoM THAs
may not be as benign as previous reports have suggested. Close radiological
follow-up is recommended, particularly in high-risk groups. Cite this article:
The long term biological effects of wear products
following total hip arthroplasty (THA) are unclear. However, the indications
for THA are expanding, with increasingly younger patients undergoing
the procedure. This prospective, randomised study compared two groups of patients
undergoing THA after being randomised to receive one of two different
bearing surfaces: metal-on-polyethylene (MoP) n = 22 and metal-on-metal
(MoM) n = 23. We investigated the relationship between three variables:
bearing surface (MoP Our results demonstrated significantly higher mean cobalt and
chromium (Co and Cr) blood levels in the MoM group at all follow-up
points following surgery (p <
0.01), but there were no significant
differences in the chromosomal aberration indices between MoM and
MoP at two or five years (two years: p = 0.56, p = 0.08, p = 0.91, p
= 0.51 and five years: p = 0.086, p = 0.73, p = 0.06, p = 0.34)
for translocations, breaks, loss and gain of chromosomes respectively.
Regression analysis showed a strong linear relationship between
Cr levels and the total chromosomal aberration indices in the MoM
group (R2 = 0.90016), but this was not as strong for
Co (R2 = 0.68991). In the MoP group, the analysis revealed
a poor relationship between Cr levels and the total chromosomal
aberration indices (R2 = 0.23908) but a slightly stronger
relationship for Co (R2 = 0.64292). Across both groups,
Spearman’s correlation detected no overall association between Co and Cr
levels and each of the studied chromosomal aberrations. There remains
no clear indication which THA bearing couple is the most biocompatible,
especially in young active patients. While THA continues to be very
successful at alleviating pain and restoring function, the long-term
biological implications of the procedure still require further scrutiny. Cite this article:
Ceramic-on-ceramic (CoC) bearings in total hip arthroplasty (THA)
are commonly used, but concerns exist regarding ceramic fracture.
This study aims to report the risk of revision for fracture of modern
CoC bearings and identify factors that might influence this risk,
using data from the National Joint Registry (NJR) for England, Wales, Northern
Ireland and the Isle of Man. We analysed data on 223 362 bearings from 111 681 primary CoC
THAs and 182 linked revisions for bearing fracture recorded in the
NJR. We used implant codes to identify ceramic bearing composition
and generated Kaplan-Meier estimates for implant survivorship. Logistic
regression analyses were performed for implant size and patient specific
variables to determine any associated risks for revision.Aims
Patients and Methods
Ceramic-on-metal (CoM) is a relatively new bearing
combination for total hip arthroplasty (THA) with few reported outcomes.
A total of 287 CoM THAs were carried out in 271 patients (mean age
55.6 years (20 to 77), 150 THAs in female patients, 137 in male)
under the care of a single surgeon between October 2007 and October
2009. With the issues surrounding metal-on-metal bearings the decision
was taken to review these patients between March and November 2011,
at a mean follow-up of 34 months (23 to 45) and to record pain,
outcome scores, radiological analysis and blood ion levels. The
mean Oxford Hip Score was 19.2 (12 to 53), 254 patients with 268
hips (95%) had mild/very mild/no pain, the mean angle of inclination
of the acetabular component was 44.8o (28o to
63o), 82 stems (29%) had evidence of radiolucent lines
of >
1 mm in at least one Gruen zone and the median levels of cobalt
and chromium ions in the blood were 0.83 μg/L (0.24 μg/L to 27.56 μg/L)
and 0.78 μg/L (0.21 μg/L to 8.84 μg/L), respectively. The five-year
survival rate is 96.9% (95% confidence interval 94.7% to 99%). Due to the presence of radiolucent lines and the higher than
expected levels of metal ions in the blood, we would not recommend
the use of CoM THA without further long-term follow-up. We plan
to monitor all these patients regularly. Cite this article:
We wished to investigate the influence of metal debris exposure
on the subsequent immune response and resulting soft-tissue injury
following metal-on-metal (MoM) hip arthroplasty. Some reports have
suggested that debris generated from the head-neck taper junction
is more destructive than equivalent doses from metal bearing surfaces. We investigated the influence of the source and volume of metal
debris on chromium (Cr) and cobalt (Co) concentrations in corresponding
blood and hip synovial fluid samples and the observed agglomerated
particle sizes in excised tissues using multiple regression analysis
of prospectively collected data. A total of 199 explanted MoM hips
(177 patients; 132 hips female) were analysed to determine rates
of volumetric wear at the bearing surfaces and taper junctions. Aims
Patients and Methods
The use of ceramic femoral heads in total hip arthroplasty (THA) has increased due to their proven low bearing wear characteristics. Ceramic femoral heads are also thought to reduce wear and corrosion at the head-stem junction with titanium (Ti) stems when compared with metal heads. We sought to evaluate taper damage of ceramic compared with metal heads when paired with cobalt chromium (CoCr) alloy stems in a single stem design. This retrieval study involved 48 total hip arthroplasties (THAs) with CoCr V40 trunnions paired with either CoCr (n = 21) or ceramic (n = 27) heads. The taper junction of all hips was evaluated for fretting/corrosion damage and volumetric material loss using a roundness-measuring machine. We used linear regression analysis to investigate taper damage differences after adjusting for potential confounding variables.Objectives
Methods
To determine the outcomes following revision surgery of metal-on-metal
hip arthroplasties (MoMHA) performed for adverse reactions to metal
debris (ARMD), and to identify factors predictive of re-revision. We performed a retrospective observational study using National
Joint Registry (NJR) data on 2535 MoMHAs undergoing revision surgery
for ARMD between 2008 and 2014. The outcomes studied following revision were
intra-operative complications, mortality and re-revision surgery.
Predictors of re-revision were identified using competing-risk regression
modelling.Aims
Patients and Methods
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.
We retrospectively analysed concentrations of chromium and cobalt ions in samples of synovial fluid and whole blood taken from a group of 92 patients with failed current-generation metal-on-metal hip replacements. We applied acid oxidative digestion to our trace metal analysis protocol, which found significantly higher levels of metal ion concentrations in blood and synovial fluid than a non-digestive method. Patients were subcategorised by mode of failure as either ‘unexplained pain’ or ‘defined causes’. Using this classification, chromium and cobalt ion levels were present over a wider range in synovial fluid and not as strongly correlated with blood ion levels as previously reported. There was no significant difference between metal ion concentrations and manufacturer of the implant, nor femoral head size below or above 50 mm. There was a moderately positive correlation between metal ion levels and acetabular component inclination angle as measured on three-dimensional CT imaging. Our results suggest that acid digestion of samples of synovial fluid samples is necessary to determine metal ion concentrations accurately so that meaningful comparisons can be made between studies.
This is a longitudinal study of the daily urinary output and the concentrations in whole blood of cobalt and chromium in patients with metal-on-metal resurfacings over a period of four years. Twelve-hour urine collections and whole blood specimens were collected before and periodically after a Birmingham hip resurfacing in 26 patients. All ion analyses were carried out using a high-resolution inductively-coupled plasma mass spectrometer. Clinical and radiological assessment, hip function scoring and activity level assessment revealed excellent hip function. There was a significant early increase in urinary metal output, reaching a peak at six months for cobalt and one year for chromium post-operatively. There was thereafter a steady decrease in the median urinary output of cobalt over the following three years, although the differences are not statistically significant. The mean whole blood levels of cobalt and chromium also showed a significant increase between the pre-operative and one-year post-operative periods. The blood levels then decreased to a lower level at four years, compared with the one-year levels. This late reduction was statistically significant for chromium but not for cobalt. The effects of systemic metal ion exposure in patients with metal-on-metal resurfacing arthroplasties continue to be a matter of concern. The levels in this study provide a baseline against which the
We present the clinical results and survivorship
of consecutive 100 Birmingham Hip Resurfacings in 90 patients at
a minimum follow-up of ten years. All procedures were carried out
by an independent surgeon who commenced a prospective study in 1998.
Patients were assessed clinically using the Western Ontario and
McMaster Universities osteoarthritis index, Short-Form 36, Harris
hip score and University of California, Los Angeles activity score. Radiological
analysis was performed by an independent observer and blood metal
ion levels concentrations were measured at ten years post-operatively
in 62 patients. The median acetabular component inclination was
46.2° (34° to 59°) and anteversion 11.0° (0° to 30°). The median
chromium concentration in the unilateral group was 1.74 (0.41 to
15.23) and for the bilateral group was 2.98 (1.57 to 18.01). The
equivalent values for cobalt were 1.67 (0.54 to 20.4) and 1.88 (1.38
to 19.32). In total there were eight failures giving an overall survival
at ten years of 92% (95% confidence interval (CI) 86.7 to 97.3).
BHR in male patients had an improved survivorship of 94.6% (95%
CI 89.4 to 100) compared with females at 84.6% (95% CI 70.7 to 98.5),
but this did not reach statistical significance (p = 0.119). Four
of the nine BHRs with a bearing diameter of 42 mm failed. The overall results were consistent with data produced from other
centres in that the clinical outcome of large male patients was
extremely encouraging, whereas the survival of the smaller joints
was less satisfactory.
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 prosthetic failure, variables associated with high metal ion concentrations should be identified and, if possible, corrected. Our study provides data on metal ion levels from a series of 76 consecutive patients (76 hips) after resurfacing arthroplasty with the Articular Surface Replacement. Chromium and cobalt ion concentrations in the whole blood of patients with smaller (≤ 51 mm) femoral components were significantly higher than in those with the larger (≥ 53 mm) components (p <
0.01). Ion concentrations in the former group were significantly related to the inclination (p = 0.01) and anteversion (p = 0.01) of the acetabular component. The same relationships were not significant in the patients with larger femoral components (p = 0.61 and p = 0.49, respectively). Accurate positioning of the acetabular component intra-operatively is essential in order to reduce the concentration of metal ions in the blood after hip resurfacing arthroplasty with the Articular Surface Replacement implant.
The aims of this study were to compare the diagnostic test characteristics
of ultrasound alone, metal artefact reduction sequence MRI (MARS-MRI)
alone, and ultrasound combined with MARS-MRI for identifying intra-operative
pseudotumours in metal-on-metal hip resurfacing (MoMHR) patients
undergoing revision surgery. This retrospective diagnostic accuracy study involved 39 patients
(40 MoMHRs). The time between imaging modalities was a mean of 14.6
days (0 to 90), with imaging performed at a mean of 5.3 months (0.06
to 12) before revision. The prevalence of intra-operative pseudotumours
was 82.5% (n = 33).Aims
Methods
We measured the orientation of the acetabular and femoral components in 45 patients (33 men, 12 women) with a mean age of 53.4 years (30 to 74) who had undergone revision of metal-on-metal hip resurfacings. Three-dimensional CT was used to measure the inclination and version of the acetabular component, femoral version and the horizontal femoral offset, and the linear wear of the removed acetabular components was measured using a roundness machine. We found that acetabular version and combined version of the acetabular and femoral components were weakly positively correlated with the rate of wear. The acetabular inclination angle was strongly positively correlated with the rate of wear. Femoral version was weakly negatively correlated with the rate of wear. Application of a threshold of >
5 μm/year for the rate of wear in order to separate the revisions into low or high wearing groups showed that more high wearing components were implanted outside Lewinnek’s safe zone, but that this was mainly due to the inclination of the acetabular component, which was the only parameter that significantly differed between the groups. We were unable to show that excess version of the acetabular component alone or combined with femoral version was associated with an increase in the rate of wear based on our assessment of version using CT.
Metal ions generated from joint replacements are a cause for concern. There is no consensus on the best surrogate measure of metal ion exposure. This study investigates whether serum and whole blood concentrations can be used interchangeably to report results of cobalt and chromium ion concentrations. Concentrations of serum and whole blood were analysed in 262 concurrent specimens using high resolution inductively-coupled plasma mass-spectrometry. The agreement was assessed with normalised scatterplots, mean difference and the Bland and Altman limits of agreement. The wide variability seen in the normalised scatterplots, in the Bland and Altman plots and the statistically significant mean differences between serum and whole blood concentrations suggest that they cannot be used interchangeably. A bias was demonstrated for both ions in the Bland-Altman plots. Regression analysis provided a possible conversion factor of 0.71 for cobalt and 0.48 for chromium. However, even when the correction factors were applied, the limits of agreement were greater than ±67% for cobalt and greater than ±85% for chromium, suggesting that serum and whole blood cannot be used interconvertibly. This suggests that serum metal concentrations are not useful as a surrogate measure of systemic metal ion exposure.
The issues surrounding raised levels of metal
ions in the blood following large head metal-on-metal total hip replacement
(THR), such as cobalt and chromium, have been well documented. Despite
the national popularity of uncemented metal-on-polyethylene (MoP)
THR using a large-diameter femoral head, few papers have reported
the levels of metal ions in the blood following this combination.
Following an isolated failure of a 44 mm Trident–Accolade uncemented
THR associated with severe wear between the femoral head and the
trunnion in the presence of markedly elevated levels of cobalt ions
in the blood, we investigated the relationship between modular femoral head
diameter and the levels of cobalt and chromium ions in the blood
following this THR. A total of 69 patients received an uncemented Trident–Accolade
MoP THR in 2009. Of these, 43 patients (23 men and 20 women, mean
age 67.0 years) were recruited and had levels of cobalt and chromium
ions in the blood measured between May and June 2012. The patients
were then divided into three groups according to the diameter of
the femoral head used: 12 patients in the 28 mm group (controls),
18 patients in the 36 mm group and 13 patients in the 40 mm group.
A total of four patients had identical bilateral prostheses in situ
at phlebotomy: one each in the 28 mm and 36 mm groups and two in
the 40 mm group. There was a significant increase in the mean levels of cobalt
ions in the blood in those with a 36 mm diameter femoral head compared
with those with a 28 mm diameter head (p = 0.013). The levels of
cobalt ions in the blood were raised in those with a 40 mm diameter
head but there was no statistically significant difference between
this group and the control group (p = 0.152). The levels of chromium
ions in the blood were normal in all patients. The clinical significance of this finding is unclear, but we
have stopped using femoral heads with a diameter of ≤ 36 mm, and
await further larger studies to clarify whether, for instance, this
issue particularly affects this combination of components. Cite this article:
We report the long-term survival and functional
outcome of the Birmingham Hip Resurfacing (BHR) in patients aged <
50 years at operation, and explore the factors affecting survival.
Between 1997 and 2006, a total of 447 BHRs were implanted in 393
patients (mean age 41.5 years (14.9 to 49.9)) by one designing surgeon.
The mean follow-up was 10.1 years (5.2 to 14.7), with no loss to
follow-up. In all, 16 hips (3.6%) in 15 patients were revised, giving
an overall cumulative survival of 96.3% (95% confidence interval
(CI) 93.7 to 98.3) at ten years and 94.1% (95% CI 84.9 to 97.3)
at 14 years. Using aseptic revision as the endpoint, the survival
for men with primary osteoarthritis (n = 195) was 100% (95% CI 100
to 100) at both ten years and 14 years, and in women with primary
osteoarthritis (n = 109) it was 96.1% (95% CI 90.1 to 99.9) at ten
years and 91.2% (95% CI 68.6 to 98.7) at 14 years. Female gender
(p = 0.047) and decreasing femoral head size (p = 0.044) were significantly
associated with an increased risk of revision. The median Oxford
hip score (OHS, modified as a percentage with 100% indicating worst
outcome) at last follow-up was 4.2% (46 of 48; interquartile range
(IQR) 0% to 24%) and the median University of California, Los Angeles
(UCLA) score was 6.0 (IQR 5 to 8). Men had significantly better
OHS (p = 0.02) and UCLA scores (p = 0.01) than women. The BHR provides
excellent survival and functional results in men into the second
decade, with good results achieved in appropriately selected women. Cite this article:
In this paper, we will consider the current role
of metal-on-metal bearings by looking at three subtypes of MoM hip
arthroplasty separately: Hip resurfacing, large head (>
36 mm) MoM
THA and MoM THA with traditional femoral head sizes.
The purpose of this study was twofold: first,
to determine whether the five-year results of hip resurfacing arthroplasty
(HRA) in Canada justified the continued use of HRA; and second,
to identify whether greater refinement of patient selection was
warranted. This was a retrospective cohort study that involved a review
of 2773 HRAs performed between January 2001 and December 2008 at
11 Canadian centres. Cox’s proportional hazards models were used
to analyse the predictors of failure of HRA. Kaplan–Meier survival
analysis was performed to predict the cumulative survival rate at
five years. The factors analysed included age, gender, body mass
index, pre-operative hip pathology, surgeon’s experience, surgical
approach, implant sizes and implant types. The most common modes
of failure were also analysed. The 2773 HRAs were undertaken in 2450 patients: 2127 in men and
646 in women. The mean age at operation was 50.5 years ( The failure rates of HRA at five years justify the ongoing use
of this technique in men. Female gender is an independent predictor
of failure, and a higher failure rate at five years in women leads
the authors to recommend this technique only in exceptional circumstances
for women. Cite this article:
A total of 219 hips in 192 patients aged between
18 and 65 years were randomised to 28-mm metal-on-metal uncemented
total hip replacements (THRs, 107 hips) or hybrid hip resurfacing
(HR, 112 hips). At a mean follow-up of eight years (6.6 to 9.3)
there was no significant difference between the THR and HR groups
regarding rate of revision (4.0% (4 of 99) Cite this article:
Following the recall of modular neck hip stems
in July 2012, research into femoral modularity will intensify over
the next few years. This review aims to provide surgeons with an
up-to-date summary of the clinically relevant evidence. The development
of femoral modularity, and a classification system, is described.
The theoretical rationale for modularity is summarised and the clinical
outcomes are explored. The review also examines the clinically relevant problems
reported following the use of femoral stems with a modular neck. Joint replacement registries in the United Kingdom and Australia
have provided data on the failure rates of modular devices but cannot
identify the mechanism of failure. This information is needed to
determine whether modular neck femoral stems will be used in the
future, and how we should monitor patients who already have them implanted. Cite this article:
In a double-blinded randomised controlled trial,
83 patients with primary osteoarthritis of the hip received either
a ceramic-on-metal (CoM) or metal-on-metal (MoM) total hip replacement
(THR). The implants differed only in the bearing surfaces used.
The serum levels of cobalt and chromium and functional outcome scores
were compared pre-operatively and at six and 12 months post-operatively. Data were available for 41 CoM and 36 MoM THRs (four patients
were lost to follow-up, two received incorrect implants). The baseline
characteristics of both cohorts were similar. Femoral head size
measured 36 mm in all but two patients who had 28 mm heads. The
mean serum cobalt and chromium levels increased in both groups,
with no difference noted between groups at six months (cobalt p
= 0.67, chromium p = 0.87) and 12 months (cobalt p = 0.76, chromium
p = 0.76) post-operatively. Similarly, the mean Oxford hip scores,
Western Ontario and McMaster Universities Osteoarthritis index and
University of California, Los Angeles activity scores showed comparable improvement
at 12 months. Our findings indicate that CoM and MoM couplings are associated
with an equivalent increase in serum cobalt and chromium levels,
and comparable functional outcome scores at six and 12-months follow-up.
There is widespread concern regarding the incidence of adverse soft-tissue reactions after metal-on-metal (MoM) hip replacement. Recent National Joint Registry data have shown clear differences in the rates of failure of different designs of hip resurfacing. Our aim was to update the failure rates related to metal debris for the Articular Surface Replacement (ASR). A total of 505 of these were implanted. Kaplan-Meier analysis showed a failure rate of 25% at six years for the ASR resurfacing and of 48.8% for the ASR total hip replacement (THR). Of 257 patients with a minimum follow-up of two years, 67 (26.1%) had a serum cobalt concentration which was greater than 7 μg/l. Co-ordinate measuring machine analysis of revised components showed that all patients suffering adverse tissue reactions in the resurfacing group had abnormal wear of the bearing surfaces. Six THR patients had relatively low rates of articular wear, but were found to have considerable damage at the trunion-taper interface. Our results suggest that wear at the modular junction is an important factor in the development of adverse tissue reactions after implantation of a large-diameter MoM THR.
An ongoing prospective study to investigate failing metal-on-metal
hip prostheses was commenced at our centre in 2008. We report on
the results of the analysis of the first consecutive 126 failed
mated total hip prostheses from a single manufacturer. Analysis was carried out using highly accurate coordinate measuring
to calculate volumetric and linear rates of the articular bearing
surfaces and also the surfaces of the taper junctions. The relationship
between taper wear rates and a number of variables, including bearing
diameter and orientation of the acetabular component, was investigated.Objectives
Methods
We describe the findings at six years in an ongoing prospective clinicoradiological and metal ion study in a cohort of 26 consecutive male patients with unilateral Birmingham Hip Resurfacing arthroplasties with one of two femoral head sizes (50 mm and 54 mm). Their mean age was 52.9 years (29 to 67). We have previously shown an early increase in the 24-hour urinary excretion of metal ions, reaching a peak at six months (cobalt) and one year (chromium) after operation. Subsequently there is a decreasing trend in excretion of both cobalt and chromium. The levels of cobalt and chromium in whole blood also show a significant increase at one year, followed by a decreasing trend until the sixth year.
This systematic review of the literature summarises
the clinical experience with ceramic-on-ceramic hip bearings over
the past 40 years and discusses the concerns that exist in relation
to the bearing combination. Loosening, fracture, liner chipping
on insertion, liner canting and dissociation, edge-loading and squeaking
have all been reported, and the relationship between these issues
and implant design and surgical technique is investigated. New design
concepts are introduced and analysed with respect to previous clinical
experience.
This study reports the mid-term results of a large-bearing hybrid metal-on-metal total hip replacement in 199 hips (185 patients) with a mean follow-up of 62 months (32 to 83). Two patients died of unrelated causes and 13 were lost to follow-up. In all, 17 hips (8.5%) have undergone revision, and a further 14 are awaiting surgery. All revisions were symptomatic. Of the revision cases, 14 hips showed evidence of adverse reactions to metal debris. The patients revised or awaiting revision had significantly higher whole blood cobalt ion levels (p = 0.001), but no significant difference in acetabular component size or position compared with the unrevised patients. Wear analysis (n = 5) showed increased wear at the trunnion-head interface, normal levels of wear at the articulating surfaces and evidence of corrosion on the surface of the stem. The cumulative survival rate, with revision for any reason, was 92.4% (95% confidence interval 87.4 to 95.4) at five years. Including those awaiting surgery, the revision rate would be 15.1% with a cumulative survival at five years of 89.6% (95% confidence interval 83.9 to 93.4). This hybrid metal-on-metal total hip replacement series has shown an unacceptably high rate of failure, with evidence of high wear at the trunnion-head interface and passive corrosion of the stem surface. This raises concerns about the use of large heads on conventional 12/14 tapers.
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 9.8% 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.
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 these devices. They may cause soft-tissue destruction with severe symptoms and a poor outcome after revision surgery. The aim of this study was to determine the incidence of and risk factors for pseudotumours that are serious enough to require revision surgery. Since 1999, 1419 metal-on-metal hip resurfacings have been implanted by our group in 1224 patients; 1.8% of the patients had a revision for pseudotumour. In this series the Kaplan-Meier cumulative revision rate for pseudotumour increased progressively with time. At eight years, in all patients, it was 4% (95% confidence interval (CI) 2.2 to 5.8). Factors significantly associated with an increase in revision rate were female gender (p <
0.001), age under 40 (p = 0.003), small components (p = 0.003), and dysplasia (p = 0.019), whereas implant type was not (p = 0.156). These factors were inter-related, however, and on fitting a Cox proportional hazard model only gender (p = 0.002) and age (p = 0.024) had a significant independent influence on revision rate; size nearly reached significance (p = 0.08). Subdividing the cohort according to significant factors, we found that the revision rate for pseudotumours in men was 0.5% (95% CI 0 to 1.1) at eight years wheras in women over 40 years old it was 6% (95% CI 2.3 to 10.1) at eight years and in women under 40 years it was 13.1% at six years (95% CI 0 to 27) (p <
0.001). We recommend that resurfacings are undertaken with caution in women, particularly those under 40 years of age but they remain a good option in young men. Further work is required to understand the aetiology of pseudotumours so that this complication can be avoided.
We have studied the relationship between metal ion levels and lymphocyte counts in patients with metal-on-metal hip resurfacings. Peripheral blood samples were analysed for lymphocyte subtypes and whole blood cobalt and chromium ion levels in 68 patients (34 with metal-on-metal hip resurfacings and 34 with standard metal-on-polyethylene total hip replacements). All hip components were radiologically well-fixed and the patients were asymptomatic. Cobalt and chromium levels were significantly elevated in the patients with metal-on-metal hip resurfacings, compared with the patients with standard metal-on-polyethylene designs (p <
0.0001). There was a statistically significant decrease in the level of CD8+ cells (T-cytotoxic/suppressor) (p = 0.005) in the metal-on-metal hip resurfacing group. A threshold level of blood cobalt and chromium ions was associated with reduced CD8+ T-cell counts. We have no evidence that our patients suffered as a result of this reduced level of CD8+ T-cells.
We evaluated the concentrations of chromium and cobalt ions in blood after metal-on-metal surface replacement arthroplasty using a wrought-forged, high carbon content chromium-cobalt alloy implant in 64 patients. At one year, mean whole blood ion levels were 1.61 μg/L (0.4 to 5.5) for chromium and 0.67 μg/L (0.23 to 2.09) for cobalt. The pre-operative ion levels, component size, female gender and the inclination of the acetabular component were inversely proportional to the values of chromium and/or cobalt ions at one year postoperatively. Other factors, such as age and level of activity, did not correlate with the levels of metal ions. We found that the levels of the ions in the serum were 1.39 and 1.37 times higher for chromium and cobalt respectively than those in the whole blood. The levels of metal ions obtained may be specific to the hip resurfacing implant and reflect its manufacturing process.