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
Radiostereometric analysis (RSA) can detect early
micromovement in unstable implant designs which are likely subsequently
to have a high failure rate. In 2010, the Articular Surface Replacement
(ASR) was withdrawn because of a high failure rate. In 19
The aims of this study were to determine if an increasing serum cobalt (Co) and/or chromium (Cr) concentration is correlated with a decreasing Harris Hip Score (HHS) and Hip disability and Osteoarthritis Outcome Score (HOOS) in patients who received the Articular Surface Replacement (ASR) hip resurfacing arthroplasty (HRA), and to evaluate the ten-year revision rate and show if sex, inclination angle, and Co level influenced the revision rate. A total of 62 patients with an ASR-HRA were included and monitored yearly postoperatively. At follow-up, serum Co and Cr levels were measured and the HHS and the HOOS were scored. In addition, preoperative patient and implant variables and the need for revision surgery were recorded. We used a linear mixed model to relate the serum Co and Cr levels to different patient-reported outcome measures (PROMs). For the survival analyses we used the Kaplan-Meier and Cox regression model.Aims
Methods
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
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
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
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
Objectives. The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy
We present the early clinical and radiological results of Articular Surface Replacement (ASR) resurfacings in 214 hips (192 patients) with a mean follow-up of 43 months (30 to 57). The mean age of the patients was 56 years (28 to 74) and 85 hips (40%) were in 78 women. The mean Harris hip score improved from 52 (11 to 81) to 95 (27 to 100) at two years and the mean University of California, Los Angeles activity score from 3.9 (1 to 10) to 7.4 (2 to 10) in the same period. Narrowing of the neck (to a maximum of 9%) was noted in 124 of 209 hips (60%). There were 12 revisions (5.6%) involving four (1.9%) early fractures of the femoral neck and two (0.9%) episodes of collapse of the femoral head secondary to avascular necrosis. Six patients (2.8%) had failure related to metal wear debris. The overall survival for our series was 93% (95% confidence interval 80 to 98) and 89% (95% confidence interval 82 to 96) for hips with acetabular components smaller than 56 mm in diameter. The
Hip resurfacing remains a potentially valuable surgical procedure for appropriately-selected patients with optimised implant choices. However, concern regarding high early failure rates continues to undermine confidence in use. A large contributor to failure is adverse local tissue reactions around metal-on-metal (MoM) bearing surfaces. Such phenomena have been well-explored around MoM total hip arthroplasties, but comparable data in equivalent hip resurfacing procedures is lacking. In order to define genetic predisposition, we performed a case-control study investigating the role of human leucocyte antigen (HLA) genotype in the development of pseudotumours around MoM hip resurfacings. A matched case-control study was performed using the prospectively-collected database at the host institution. In all, 16 MoM hip resurfacing 'cases' were identified as having symptomatic periprosthetic pseudotumours on preoperative metal artefact reduction sequence (MARS) MRI, and were subsequently histologically confirmed as high-grade aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) at revision surgery. ‘Controls’ were matched by implant type in the absence of evidence of pseudotumour. Blood samples from all cases and controls were collected prospectively for high resolution genetic a nalysis targeting 11 separate HLA loci. Statistical significance was set at 0.10 a priori to determine the association between HLA genotype and pseudotumour formation, given the small sample size.Aims
Methods
This study aims to assess the relationship between history of pseudotumour formation secondary to metal-on-metal (MoM) implants and periprosthetic joint infection (PJI) rate, as well as establish ESR and CRP thresholds that are suggestive of infection in these patients. We hypothesized that patients with a pseudotumour were at increased risk of infection. A total of 1,171 total hip arthroplasty (THA) patients with MoM articulations from August 2000 to March 2014 were retrospectively identified. Of those, 328 patients underwent metal artefact reduction sequence MRI and had minimum two years’ clinical follow-up, and met our inclusion criteria. Data collected included demographic details, surgical indication, laterality, implants used, history of pseudotumour, and their corresponding preoperative ESR (mm/hr) and CRP (mg/dl) levels. Multivariate logistic regression modelling was used to evaluate PJI and history of pseudotumour, and receiver operating characteristic curves were created to assess the diagnostic capabilities of ESR and CRP to determine the presence of infection in patients undergoing revision surgery.Aims
Methods
In 2015, we published the results of our ceramic-on-metal (CoM) total hip arthroplasties (THAs) performed between October 2007 and July 2009 with a mean follow-up of 34 months (23 to 45) and a revision rate of 3.1%. The aim of this paper is to present the longer-term outcomes. A total of 264 patients were reviewed at a mean of 5.8 years (4.6 to 7.2) and 10.1 years (9.2 to 10.6) to determine revision rate, pain, outcome scores, radiological analysis, and blood ion levels. Those who were unwilling or unable to travel were contacted by telephone.Aims
Methods
Taper corrosion has been widely reported to be problematic for modular total hip arthroplasty implants. A simple and systematic method to evaluate taper damage with sufficient resolution is needed. We introduce a semiquantitative grading system for modular femoral tapers to characterize taper corrosion damage. After examining a unique collection of retrieved cobalt-chromium (CoCr) taper sleeves (n = 465) using the widely-used Goldberg system, we developed an expanded six-point visual grading system intended to characterize the severity, visible material loss, and absence of direct component contact due to corrosion. Female taper sleeve damage was evaluated by three blinded observers using the Goldberg scoring system and the expanded system. A subset (n = 85) was then re-evaluated following destructive cleaning, using both scoring systems. Material loss for this subset was quantified using metrology and correlated with both scoring systems.Aims
Methods
The Birmingham Hip Resurfacing (BHR) was introduced in 1997 to address the needs of young active patients using a historically proven large-diameter metal-on-metal (MoM) bearing. A single designer surgeon’s consecutive series of 130 patients (144 hips) was previously reported at five and ten years, reporting three and ten failures, respectively. The aim of this study was to extend the follow-up of this original cohort at 25 years. The study extends the reporting on the first consecutive 144 resurfacing procedures in 130 patients for all indications. All operations were undertaken between August 1997 and May 1998. The mean age at operation was 52.1 years (SD 9.93; 17 to 76), and included 37 female patients (28.5%). Failure was defined as revision of either component for any reason. Kaplan-Meier survival analysis was performed. Routine follow-up with serum metal ion levels, radiographs, and Oxford Hip Scores (OHSs) was undertaken.Aims
Methods
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. 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 blood metal ion levels and eGFR to identify a potential trend of accumulating Co or Cr with decreasing eGFR.Aims
Methods
Elevated levels of circulating cobalt ions have been linked with a wide range of systemic complications including neurological, endocrine, and cardiovascular symptoms. Case reports of patients with elevated blood cobalt ions have described significant cardiovascular complications including cardiomyopathy. However, correlation between the actual level of circulating cobalt and extent of cardiovascular injury has not previously been performed. This review examines evidence from the literature for a link between elevated blood cobalt levels secondary to metal-on-metal (MoM) hip arthroplasties and cardiomyopathy. Correlation between low, moderate, and high blood cobalt with cardiovascular complications has been considered. Elevated blood cobalt at levels over 250 µg/l have been shown to be a risk factor for developing systemic complications and published case reports document cardiomyopathy, cardiac transplantation, and death in patients with severely elevated blood cobalt ions. However, it is not clear that there is a hard cut-off value and cardiac dysfunction may occur at lower levels. Clinical and laboratory research has found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. Further work needs to be done to clarify the link between severely elevated blood cobalt ions and cardiomyopathy. Cite this article:
Adverse local tissue reactions associated with abnormal wear considerably slowed down the general use of metal-on-metal (MoM) hip resurfacing arthroplasty (HRA), now limited to a few specialized centres. In this study, we provide the clinical results of 400 consecutive MoM HRAs implanted more than 20 years ago in one such centre. A total of 355 patients (400 hips) were treated with Conserve Plus HRA between November 1996 and November 2000. There were 96 female (27%) and 259 male patients (73%). Their mean age was 48.2 years (SD 10.9). The University of California, Los Angeles (UCLA) hip scores and 12-item Short Form Survey (SF-12) quality of life scores were reported. Survivorship was assessed using Kaplan-Meier analyses.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
Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations. Hypothetical implant brand portfolios were proposed, and the number of compatible implant construct combinations was calculated.Aims
Methods
Modern metal-on-metal (MoM) hip resurfacing arthroplasty (HRA), while achieving good results with well-orientated, well-designed components in ideal patients, is contraindicated in women, men with head size under 50 mm, or metal hypersensitivity. These patients currently have no access to the benefits of HRA. Highly crosslinked polyethylene (XLPE) has demonstrated clinical success in total hip arthroplasty (THA) and, when used in HRA, potentially reduces metal ion-related sequelae. We report the early performance of HRA using a direct-to-bone cementless mono-bloc XLPE component coupled with a cobalt-chrome femoral head, in the patient group for whom HRA is currently contraindicated. This is a cross-sectional, observational assessment of 88 consecutive metal-on-XLPE HRAs performed in 84 patients between 2015 and 2018 in three centres (three surgeons, including the designer surgeon). Mean follow-up is 1.6 years (0.7 to 3.9). Mean age at operation was 56 years (Objectives
Methods
We have encountered patients who developed large joint fluid collections with massive elevations in chromium (Cr) and cobalt (Co) concentrations following metal-on-metal (MoM) hip arthroplasties. In some cases, retrieval analysis determined that these ion concentrations could not be explained simply by the wear rates of the components. We hypothesized that these effects may be associated with aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL). We examined the influence of the ALVAL grade on synovial fluid Co and Cr concentrations following adjustment for patient and device variables, including volumetric wear rates. Initially restricting the analysis to include only patients with one MoM hip resurfacing device, we performed multiple regression analyses of prospectively collected data. We then repeated the same statistical approach using results from a larger cohort with different MoM designs, including total hip arthroplasties.Objectives
Patients and Methods
The aim of this study was to determine whether patients with
metal-on-metal (MoM) arthroplasties of the hip have an increased
risk of cardiac failure compared with those with alternative types
of arthroplasties (non-MoM). A linkage study between the National Joint Registry, Hospital
Episodes Statistics and records of the Office for National Statistics
on deaths was undertaken. Patients who underwent elective total
hip arthroplasty between January 2003 and December 2014 with no
past history of cardiac failure were included and stratified as
having either a MoM (n = 53 529) or a non-MoM (n = 482 247) arthroplasty.
The primary outcome measure was the time to an admission to hospital
for cardiac failure or death. Analysis was carried out using data
from all patients and from those matched by propensity score.Aims
Patients and 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
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
High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015.Objectives
Methods
A contact patch to rim (CPR) distance of <
10 mm has been
associated with edge-loading and excessive wear. However, not all
arthroplasties with a low CPR distance show problems with wear.
Therefore, CPR distance may not be the only variable affecting the
post-operative metal ion concentrations. We used multiple logistic regression to determine what variables
differed between the patients who had high and low cobalt (CoS)
and chromium (CrS) serum ion concentrations within a cohort of patients
with low (<
10 mm) CPR distances. A total of 56 patients treated
with unilateral hip resurfacing arthroplasty (HRA) had CoS and CrS
ion studies performed more than one year after surgery. The mean
age of the patients at the time of surgery was 51.7 years (29 to
70), with 38 women (68%) and 18 men (32%).Aims
Patients and Methods
For this retrospective cohort study, patients aged ≤ 30 years
(very young) who underwent total hip arthroplasty (THA) were compared
with patients aged ≥ 60 years (elderly) to evaluate the rate of
revision arthroplasty, implant survival, the indications for revision,
the complications, and the patient-reported outcomes. We retrospectively reviewed all patients who underwent primary
THA between January 2000 and May 2015 from our institutional database.
A total of 145 very young and 1359 elderly patients were reviewed.
The mean follow-up was 5.3 years (1 to 18). Logistic generalized
estimating equations were used to compare characteristics and the revision
rate. Survival was evaluated using Kaplan–Meier curves and hazard
rates were created using Cox regression.Aims
Patients and Methods
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
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
Hip resurfacing arthroplasty (HRA) is an alternative to conventional
total hip arthroplasty for patients with osteonecrosis (ON) of the
femoral head. Our aim was to report the long-term outcome of HRA,
which is not currently known. Long-term survivorship, clinical scores and radiographic results
for 82 patients (99 hips) treated with HRA for ON over a period
of 18 years were reviewed retrospectively. The mean age of the 67
men and 15 women at the time of surgery was 40.8 years (14 to 64).
Patients were resurfaced regardless of the size of the osteonecrotic
lesion.Aims
Patients and Methods
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. 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 Objectives
Methods
We sought to determine whether cobalt-chromium alloy (CoCr) femoral
stem tapers (trunnions) wear more than titanium (Ti) alloy stem
tapers (trunnions) when used in a large diameter (LD) metal-on-metal
(MoM) hip arthroplasty system. We performed explant analysis using validated methodology to
determine the volumetric material loss at the taper surfaces of
explanted LD CoCr MoM hip arthroplasties used with either a Ti alloy
(n = 28) or CoCr femoral stem (n = 21). Only 12/14 taper constructs
with a rough male taper surface and a nominal included angle close
to 5.666° were included. Multiple regression modelling was undertaken
using taper angle, taper roughness, bearing diameter (horizontal
lever arm) as independent variables. Material loss was mapped using
a coordinate measuring machine, profilometry and scanning electron
microscopy.Aims
Patients and Methods
We systematically reviewed the peer-reviewed literature to relate the survival of hybrid metal-on-metal hip resurfacing arthroplasty devices to a National Institute of Clinical Excellence (NICE) benchmark for choosing a primary total hip replacement, which is a survival rate of 90% at a follow-up of ten years. A total of 29 articles (10 621 resurfaced hips) met the inclusion criteria. The mean follow-up ranged from 0.6 to 10.5 years and the survival of the implant ranged from 84% to 100%. Of the 10 621 hips, 370 were revised (3.5%), with aseptic loosening as the most frequent mode of failure. None of the hip resurfacing arthroplasty implants used to date met the full ten-year NICE benchmark of survival. A total of 13 studies showed satisfactory survival compared with the three-year NICE benchmark.
Modern metal-on-metal hip resurfacing has been
widely performed in the United Kingdom for over a decade. However,
the literature reports conflicting views of the benefits: excellent
medium- to long-term results with some brands in specific subgroups,
but high failure rates and local soft-tissue reactions in others.
The National Joint Registry for England and Wales (NJR) has collected
data on all hip resurfacings performed since 2003. This retrospective
cohort study recorded survival time to revision from a resurfacing
procedure, exploring risk factors independently associated with
failure. All patients with a primary diagnosis of osteoarthritis
who underwent resurfacing between 2003 and 2010 were included in
the analyses. Cox’s proportional hazard models were used to analyse
the extent to which the risk of revision was related to patient,
surgeon and implant covariates. A total of 27 971 hip resurfacings were performed during the
study period, of which 1003 (3.59%) underwent revision surgery.
In the final adjusted model, we found that women were at greater
risk of revision than men (hazard ratio (HR) = 1.30, p = 0.007),
but the risk of revision was independent of age. Of the implant-specific
predictors, five brands had a significantly greater risk of revision
than the Birmingham Hip Resurfacing (BHR) (ASR: HR = 2.82, p <
0.001,
Conserve: HR = 2.03, p <
0.001, Cormet: HR = 1.43, p = 0.001,
Durom: HR = 1.67, p <
0.001, Recap: HR = 1.58, p = 0.007). Smaller
femoral head components were also significantly more likely to require
revision (≤ 44 mm: HR = 2.14, p <
0.001, 45 to 47 mm: HR = 1.48,
p = 0.001) than medium or large heads, as were operations performed
by low-volume surgeons (HR = 1.36, p <
0.001). Once these influences
had been removed, in 4873 male patients <
60 years old undergoing
resurfacing with a BHR, the five-year estimated risk of revision
was 1.59%. In summary, after adjustment for a range of covariates we found
that there were significant differences in the rate of failure between
brands and component sizes. Younger male patients had good five-year
implant survival when the BHR was used.
Metal-on-metal (MoM) hip resurfacing was developed in the 1990s by surgeons in Birmingham, UK, as a surgical solution to the problem of osteoarthritis in younger, more active patients. Early results were promising and the procedure gained in popularity. However, adverse reports of soft-tissue reaction and failure started to appear from 2008 onwards. Surgeons may be asked to write medico-legal reports on the surgical aspects of an individual case for claimant lawyers or in defence for the NHSLA or indemnity insurers. The purpose of this article is to cover some of the aspects of the operation that may be considered in such medico-legal reports.
This study compared component wear rates and pre-revision blood metal ions levels in two groups of failed metal-on-metal hip arthroplasties: hip resurfacing and modular total hip replacement (THR). There was no significant difference in the median rate of linear wear between the groups for both acetabular (p = 0.4633) and femoral (p = 0.0872) components. There was also no significant difference in the median linear wear rates when failed hip resurfacing and modular THR hips of the same type (ASR and Birmingham hip resurfacing (BHR)) were compared. Unlike other studies of well-functioning hips, there was no significant difference in pre-revision blood metal ion levels between hip resurfacing and modular THR. Edge loading was common in both groups, but more common in the resurfacing group (67%) than in the modular group (57%). However, this was not significant (p = 0.3479). We attribute this difference to retention of the neck in resurfacing of the hip, leading to impingement-type edge loading. This was supported by visual evidence of impingement on the femur. These findings show that failed metal-on-metal hip resurfacing and modular THRs have similar component wear rates and are both associated with raised pre-revision blood levels of metal ions.
It is accepted that resurfacing hip replacement
preserves the bone mineral density (BMD) of the femur better than total
hip replacement (THR). However, no studies have investigated any
possible difference on the acetabular side. Between April 2007 and March 2009, 39 patients were randomised
into two groups to receive either a resurfacing or a THR and were
followed for two years. One patient’s resurfacing subsequently failed,
leaving 19 patients in each group. Resurfaced replacements maintained proximal femoral BMD and,
compared with THR, had an increased bone mineral density in Gruen
zones 2, 3, 6, and particularly zone 7, with a gain of 7.5% (95%
confidence interval (CI) 2.6 to 12.5) compared with a loss of 14.6%
(95% CI 7.6 to 21.6). Resurfacing replacements maintained the BMD
of the medial femoral neck and increased that in the lateral zones
between 12.8% (95% CI 4.3 to 21.4) and 25.9% (95% CI 7.1 to 44.6). On the acetabular side, BMD was similar in every zone at each
point in time. The mean BMD of all acetabular regions in the resurfaced
group was reduced to 96.2% (95% CI 93.7 to 98.6) and for the total
hip replacement group to 97.6% (95% CI 93.7 to 101.5) (p = 0.4863).
A mean total loss of 3.7% (95% CI 1.0 to 6.5) and 4.9% (95% CI 0.8
to 9.0) of BMD was found above the acetabular component in W1 and
10.2% (95% CI 0.9 to 19.4) and 9.1% (95% CI 3.8 to 14.4) medial
to the implant in W2 for resurfaced replacements and THRs respectively.
Resurfacing resulted in a mean loss of BMD of 6.7% (95% CI 0.7 to
12.7) in W3 but the BMD inferior to the acetabular component was
maintained in both groups. These results suggest that the ability of a resurfacing hip replacement
to preserve BMD only applies to the femoral side.
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.
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.
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
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.
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.
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. 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.Objectives
Methods
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.
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.
Surgeons have commonly used modular femoral heads and stems from
different manufacturers, although this is not recommended by orthopaedic
companies due to the different manufacturing processes. We compared the rate of corrosion and rate of wear at the trunnion/head
taper junction in two groups of retrieved hips; those with mixed
manufacturers (MM) and those from the same manufacturer (SM). We identified 151 retrieved hips with large-diameter cobalt-chromium
heads; 51 of two designs that had been paired with stems from different
manufacturers (MM) and 100 of seven designs paired with stems from
the same manufacturer (SM). We determined the severity of corrosion
with the Goldberg corrosion score and the volume of material loss
at the head/stem junction. We used multivariable statistical analysis
to determine if there was a significant difference between the two
groups. Aims
Materials 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.
Joint replacement of the hip and knee remain
very satisfactory operations. They are, however, expensive. The
actual manufacturing of the implant represents only 30% of the final
cost, while sales and marketing represent 40%. Recently, the patents
on many well established and successful implants have expired. Companies
have started producing and distributing implants that purport to
replicate existing implants with good long-term results. The aims of this paper are to assess the legality, the monitoring
and cost saving implications of such generic implants. We also assess
how this might affect the traditional orthopaedic implant companies. Cite this article:
Modular junctions are ubiquitous in contemporary hip arthroplasty. The head-trunnion junction is implicated in the failure of large diameter metal-on-metal (MoM) hips which are the currently the topic of one the largest legal actions in the history of orthopaedics (estimated costs are stated to exceed $4 billion). Several factors are known to influence the strength of these press-fit modular connections. However, the influence of different head sizes has not previously been investigated. The aim of the study was to establish whether the choice of head size influences the initial strength of the trunnion-head connection. Ti-6Al-4V trunnions (n = 60) and two different sizes of cobalt-chromium (Co-Cr) heads (28 mm and 36 mm; 30 of each size) were used in the study. Three different levels of assembly force were considered: 4 kN; 5 kN; and 6 kN (n = 10 each). The strength of the press-fit connection was subsequently evaluated by measuring the pull-off force required to break the connection. The statistical differences in pull-off force were examined using a Kruskal–Wallis test and two-sample Mann–Whitney U test. Finite element and analytical models were developed to understand the reasons for the experimentally observed differences.Objectives
Materials and Methods
Blood metal ions have been widely used to investigate
metal-on-metal hip replacements, but their ability to discriminate
between well-functioning and failed hips is not known. The Medicines
and Healthcare products Regulatory Agency (MHRA) has suggested a
cut-off level of 7 parts per billion (ppb). We performed a pair-matched, case-control study to investigate
the sensitivity and specificity of blood metal ion levels for diagnosing
failure in 176 patients with a unilateral metal-on-metal hip replacement.
We recruited 88 cases with a pre-revision, unexplained failed hip
and an equal number of matching controls with a well-functioning
hip. We investigated the 7 ppb cut-off level for the maximum of
cobalt or chromium and determined optimal mathematical cut-off levels
from receiver-operating characteristic curves. The 7 ppb cut-off level for the maximum of cobalt or chromium
had a specificity of 89% and sensitivity 52% for detecting a pre-operative
unexplained failed metal on metal hip replacement. The optimal cut-off
level for the maximum of cobalt or chromium was 4.97 ppb and had
sensitivity 63% and specificity 86%. Blood metal ions had good discriminant ability to separate failed
from well-functioning hip replacements. The MHRA cut-off level of
7 ppb provides a specific test but has poor sensitivity.
We review the history and literature of hip resurfacing arthroplasty. Resurfacing and the science behind it continues to evolve. Recent results, particularly from the national arthroplasty registers, have spread disquiet among both surgeons and patients. A hip resurfacing arthroplasty is not a total hip replacement, but should perhaps be seen as a means of delaying it. The time when hip resurfacing is offered to a patient may be different from that for a total hip replacement. The same logic can apply to the timing of revision surgery. Consequently, the comparison of resurfacing with total hip replacement may be a false one. Nevertheless, the need for innovative solutions for young arthroplasty patients is clear. Total hip replacement can be usefully delayed in many of these patients by the use of hip resurfacing arthroplasty.
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:
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
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
The February 2015 Knee Roundup360 looks at: Intra-operative sensors for knee balance; Mobile bearing no advantage; Death and knee replacement: a falling phenomenon; The swings and roundabouts of unicompartmental arthroplasty; Regulation, implants and innovation; The weight of arthroplasty responsibility!; BMI in arthroplasty
Metal-on-metal resurfacing of the hip (MoMHR)
has enjoyed a resurgence in the last decade, but is now again in question
as a routine option for osteoarthritis of the hip. Proponents of
hip resurfacing suggest that its survival is superior to that of
conventional hip replacement (THR), and that hip resurfacing is
less invasive, is easier to revise than THR, and provides superior
functional outcomes. Our argument serves to illustrate that none
of these proposed advantages have been realised and new and unanticipated
serious complications, such as pseudotumors, have been associated
with the procedure. As such, we feel that the routine use of MoMHR
is not justified. Cite this article:
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:
Persistent groin pain after seemingly successful
total hip replacement (THR) appears to have become more common.
Recent studies have indicated a high incidence after metal-on-polyethylene
and metal-on-metal conventional THR and it has been documented in
up to 18% of patients after metal-on-metal resurfacing. There are many
causes, including acetabular loosening, stress fracture, and iliopsoas
tendonitis and impingement. The evaluation of this problem requires
a careful history and examination, plain radiographs and an algorithmic approach
to special diagnostic imaging and tests. Non-operative treatment
is not usually successful. Specific operative treatment depending
on the cause of the pain usually involves revision of the acetabular
component, iliopsoas tenotomy or other procedures, and is usually
successful. Here, an appropriate algorithm is described.
The December 2014 Knee Roundup360 looks at: national guidance on arthroplasty thromboprophylaxis is effective; unicompartmental knee replacement has the edge in terms of short-term complications; stiff knees, timing and manipulation; neuropathic pain and total knee replacement; synovial fluid α-defensin and CRP: a new gold standard in joint infection diagnosis?; how to assess anterior knee pain?; where is the evidence? Five new implants under the spotlight; and a fresh look at ACL reconstruction
This review examines the future of total hip arthroplasty, aiming to avoid past mistakes
Arthroplasty registries are important for the
surveillance of joint replacements and the evaluation of outcome. Independent
validation of registry data ensures high quality. The ability for
orthopaedic implant retrieval centres to validate registry data
is not known. We analysed data from the National Joint Registry
for England, Wales and Northern Ireland (NJR) for primary metal-on-metal
hip arthroplasties performed between 2003 and 2013. Records were
linked to the London Implant Retrieval Centre (RC) for validation.
A total of 67 045 procedures on the NJR and 782 revised pairs of
components from the RC were included. We were able to link 476 procedures
(60.9%) recorded with the RC to the NJR successfully. However, 306
procedures (39.1%) could not be linked. The outcome recorded by the
NJR (as either revised, unrevised or death) for a primary procedure
was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval
linkage and correct assignment of outcome code improved over time.
The rates of error for component reference numbers on the NJR were
as follows: femoral head category number 14/229 (5.0%); femoral head
batch number 13/232 (5.3%); acetabular component category number
2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). Registry-retrieval linkage provided a novel means for the validation
of data, particularly for component fields. This study suggests
that NJR reports may underestimate rates of revision for many types
of metal-on-metal hip replacement. This is topical given the increasing
scope for NJR data. We recommend a system for continuous independent
evaluation of the quality and validity of NJR data. Cite this article:
Bone surface strains were measured in cadaver femora during loading prior to and after resurfacing of the hip and total hip replacement using an uncemented, tapered femoral component. In vitro loading simulated the single-leg stance phase during walking. Strains were measured on the medial and the lateral sides of the proximal aspect and the mid-diaphysis of the femur. Bone surface strains following femoral resurfacing were similar to those in the native femur, except for proximal shear strains, which were significantly less than those in the native femur. Proximomedial strains following total hip replacement were significantly less than those in the native and the resurfaced femur. These results are consistent with previous clinical evidence of bone loss after total hip replacement, and provide support for claims of bone preservation after resurfacing arthroplasty of the hip.
Wear debris released from bearing surfaces has been shown to
provoke negative immune responses in the recipient. Excessive wear
has been linked to early failure of prostheses. Analysis using coordinate
measuring machines (CMMs) can provide estimates of total volumetric
material loss of explanted prostheses and can help to understand
device failure. The accuracy of volumetric testing has been debated,
with some investigators stating that only protocols involving hundreds
of thousands of measurement points are sufficient. We looked to
examine this assumption and to apply the findings to the clinical
arena. We examined the effects on the calculated material loss from
a ceramic femoral head when different CMM scanning parameters were
used. Calculated wear volumes were compared with gold standard gravimetric
tests in a blinded study. Objectives
Methods
This is the second of a series of reviews of registries. This review looks specifically at worldwide registry data that have been collected on knee arthroplasty, what we have learned from their reports, and what the limitations are as to what we currently know.
The February 2013 Wrist &
Hand Roundup360 looks at: to splint or not to splint; salvage of the unsalvageable; a close shave for malunions; a classic approach to malunion; diabetic carpal tunnel; capsulodesis; a wrist from a fibula; thumb-based osteoarthritis - a further opinion from the Editor-in-Chief.
A moderator and panel of five experts led an
interactive session in discussing five challenging and interesting patient
case presentations involving surgery of the hip. The hip pathologies
reviewed included failed open reduction internal fixation of subcapital
femoral neck fracture, bilateral hip disease, evaluation of pain
after metal-on-metal hip arthroplasty, avascular necrosis, aseptic
loosening secondary to osteolysis and polyethylene wear, and management
of ceramic femoral head fracture.
We report a case of a male patient presenting
with bilateral painful but apparently well-positioned and -fixed
large-diameter metal-on-metal hip replacements four years post-operatively.
Multiple imaging modes revealed a thick-walled, cystic expansile
mass in communication with the hip joint (a pseudotumour). Implant
retrieval analysis and tissue culture eliminated high bearing wear
or infection as causes for the soft-tissue reaction, but noted marked corrosion
of the modular neck taper adaptor and corrosion products in the
tissues. Therefore, we believe corrosion products from the taper
caused by mismatch of the implant components led to pseudotumour
formation requiring revision.
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.
The cortical strains on the femoral neck and proximal femur were measured before and after implantation of a resurfacing femoral component in 13 femurs from human cadavers. These were loaded into a hip simulator for single-leg stance and stair-climbing. After resurfacing, the mean tensile strain increased by 15% (95% confidence interval (CI) 6 to 24, p = 0.003) on the lateral femoral neck and the mean compressive strain increased by 11% (95% CI 5 to 17, p = 0.002) on the medial femoral neck during stimulation of single-leg stance. On the proximal femur the deformation pattern remained similar to that of the unoperated femurs. The small increase of strains in the neck area alone would probably not be sufficient to cause fracture of the neck However, with patient-related and surgical factors these strain changes may contribute to the risk of early periprosthetic fracture.
We examined the relationships between the serum levels of chromium and cobalt ions and the inclination angle of the acetabular component and the level of activity in 214 patients implanted with a metal-on-metal resurfacing hip replacement. Each patient had a single resurfacing and no other metal in their body. All serum measurements were performed at a minimum of one year after operation. The inclination of the acetabular component was considered to be steep if the abduction angle was greater than 55°. There were significantly higher levels of metal ions in patients with steeply-inclined components (p = 0.002 for chromium, p = 0.003 for cobalt), but no correlation was found between the level of activity and the concentration of metal ions. A highly significant (p <
0.001) correlation with the arc of cover was found. Arcs of cover of less than 10 mm were correlated with a greater risk of high concentrations of serum metal ions. The arc of coverage was also related to the design of the component and to size as well as to the abduction angle of the acetabular component. Steeply-inclined acetabular components, with abduction angles greater than 55°, combined with a small size of component are likely to give rise to higher serum levels of cobalt and chromium ions. This is probably due to a greater risk of edge-loading.