Aims. 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. Methods. 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. Results. Overall implant survival was 83.50% (95% confidence interval (CI) 0.79 to 0.90) at 25 years, and the number at risk was 79. Survival in male patients at 25 years was 89.5% (95% CI 0.83 to 0.96) compared to 66.9% for female patients (95% CI 0.51 to 0.83). Ten additional failures occurred in the period of ten to 25 years. These involved an adverse reaction to metal debris in four patients, a periprosthetic femoral neck fracture affecting five patients, and aseptic loosening in one patient. The median chromium levels were 49.50 nmol/l (interquartile range (IQR) 34 to 70), and the median cobalt serum levels were 42 nmol/l (IQR 24.50 to 71.25). The median OHS at last follow-up was 35 (IQR 10 to 48). During the 25-year study period, 29 patients died. Patient survival at 25 years was 75.10% (95% CI 0.67 to 0.83). Conclusion. This study demonstrates that
The aim of this study was to establish the natural
course of unrevised asymptomatic pseudotumours after metal-on-metal
(MoM) hip resurfacing during a six- to 12-month follow-up period.
We used repeated metal artefact reduction sequence (MARS)-magnetic
resonance imaging (MRI), serum metal ion analysis and clinical examination to
study 14 unrevised hips (mean patient age 52.7 years, 46 to 68,
5 female, 7 male) with a pseudotumour and 23 hips (mean patient
age 52.8 years, 38 to 69, 7 female, 16 male) without a pseudotumour.
The mean post-operative time to the first MARS-MRI scan was 4.3 years
(2.2 to 8.3), and mean time between the first and second MARS-MRI scan
was eight months (6 to 12). At the second MRI scan, the grade of
severity of the pseudotumour had not changed in 35 hips. One new
pseudotumour (Anderson C2 score, moderate) was observed, and one
pseudotumour was downgraded from C2 (moderate) to C1 (mild). In
general, the characteristics of the pseudotumours hardly changed. Repeated MARS-MRI scans within one year in patients with asymptomatic
pseudotumours after
The first aim of this study was to evaluate whether preoperative renal function is associated with postoperative changes in whole blood levels of metal ions in patients who have undergone a Birmingham Hip Resurfacing (BHR) arthroplasty with a metal-on-metal bearing. The second aim was to evaluate whether exposure to increased cobalt (Co) and chromium (Cr) levels for ten years adversely affected renal function. As part of a multicentre, prospective post-approval study, whole blood samples were sent to a single specialized laboratory to determine Co and Cr levels, and the estimated glomerular filtration rate (eGFR). The study included patients with 117 unrevised unilateral BHRs. There were 36 females (31%). The mean age of the patients at the time of surgery of 51.3 years (SD 6.5), and they all had preoperative one-, four-, five-, and ten-year laboratory data. The mean follow-up was 10.1 years (SD 0.2).Aims
Methods
We investigated whether blood metal ion levels could effectively
identify patients with bilateral Birmingham Hip Resurfacing (BHR)
implants who have adverse reactions to metal debris (ARMD). Metal ion levels in whole blood were measured in 185 patients
with bilateral BHRs. Patients were divided into those with ARMD
who either had undergone a revision for ARMD or had ARMD on imaging
(n = 30), and those without ARMD (n = 155). Receiver operating characteristic
analysis was used to determine the optimal thresholds of blood metal
ion levels for identifying patients with ARMD.Aims
Patients and Methods
Cardiac magnetic resonance (CMR) was used to assess whether cardiac function or tissue composition was affected in patients with well-functioning metal-on-metal hip resurfacing arthroplasties (MoMHRA) when compared with a group of controls, and to assess if metal ion levels correlated with any of the functional or structural parameters studied. In all, 30 participants with no significant cardiac history were enrolled: 20 patients with well-functioning MoMHRA at mean follow-up of 8.3 years post-procedure (ten unilateral, ten bilateral; 17 men, three women) and a case-matched control group of ten non-MoM total hip arthroplasty patients (six men, four women). The mean age of the whole cohort (study group and controls) at the time of surgery was 50.6 years (41.0 to 64.0). Serum levels of cobalt and chromium were measured, and all patients underwent CMR imaging, including cine, T2* measurements, T1 and T2 mapping, late gadolinium enhancement, and strain measurements.Aims
Patients and Methods
The presence of pseudotumours, which are soft-tissue masses relating to the hip, after metal-on-metal hip resurfacing arthroplasty has been associated with elevated levels of metal ions in serum, suggesting that pseudotumours occur when there is increased wear. We aimed to quantify the wear in vivo of implants revised for pseudotumours (eight) and of a control group of implants (22) revised for other reasons of failure. We found that the implant group with pseudotumours had a significantly higher rate of median linear wear of the femoral component at 8.1 μm/year (2.75 to 25.4) than the 1.79 μm/year (0.82 to 4.15; p = 0.002) of the non-pseudotumour group. For the acetabular component a significantly higher rate of median linear wear of 7.36 μm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 μm/year (0.81 to 3.33, p = 0.001) in the other group. Wear of the acetabular component in the pseudotumour group always involved the edge of the implant, indicating that edge-loading had occurred. Our findings are the first direct evidence that pseudotumour is associated with increased wear at the metal-on-metal articulation. Furthermore, edge-loading with the loss of fluid-film lubrication may be an important mechanism of generation of wear in patients with a pseudotumour.
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.
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 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.
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
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
Hip simulators have been used for ten years to determine the tribological performance of large-head metal-on-metal devices using traditional test conditions. However, the hip simulator protocols were originally developed to test metal-on-polyethylene devices. We have used patient activity data to develop a more physiologically relevant test protocol for metal-on-metal devices. This includes stop/start motion, a more appropriate walking frequency, and alternating kinetic and kinematic profiles. There has been considerable discussion about the effect of heat treatments on the wear of metal-on-metal cobalt chromium molybdenum (CoCrMo) devices. Clinical studies have shown a higher rate of wear, levels of metal ions and rates of failure for the heat-treated metal compared to the as-cast metal CoCrMo devices. However, hip simulator studies in vitro under traditional testing conditions have thus far not been able to demonstrate a difference between the wear performance of these implants. Using a physiologically relevant test protocol, we have shown that heat treatment of metal-on-metal CoCrMo devices adversely affects their wear performance and generates significantly higher wear rates and levels of metal ions than in as-cast metal implants.
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.
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
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.
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.
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.
The aim of this study was to investigate the
possible benefit of large-head metal-on-metal bearing on a stem
for primary hip replacement compared with a 28 mm diameter conventional
metal-on-polyethylene bearing in a prospective randomised controlled
trial. We investigated cemented stem behaviour between these two
different bearings using Einzel-Bild-Röntgen-Analyse, clinical and
patient reported measures (Harris hip score, Western Ontario and
McMaster Universities osteoarthritis index, Short Form-36 and satisfaction)
and whole blood metal ion levels at two years. A power study indicated
that 50 hips were needed in each group to detect subsidence of >
5 mm at two years with a
p-value of <
0.05. Significant improvement (p <
0.001) was found in the mean
clinical and patient reported outcomes at two years for both groups.
Comparison of outcomes between the groups at two years showed no
statistically significant difference for mean stem migration, clinical
and patient reported outcomes; except overall patient satisfaction which
was higher for metal-on-metal group (p = 0.05). Metal ion levels
were raised above the Medicines and Healthcare products Regulatory
Agency advised safety level (7 µg per litre) in 20% of the metal-on-metal
group and in one patient in metal-on-polyethylene group (who had
a metal-on-metal implant on the contralateral side). Two patients
in the metal-on-metal group were revised, one for pseudotumour and
one for peri-prosthetic fracture. Use of large modular heads is associated with a risk of raised
whole blood metal ion levels despite using a proven bearing from
resurfacing. The head-neck junction or excess stem micromotion are
possibly the weak links warranting further research.
Recently, the use of metal-on-metal articulations
in total hip arthroplasty (THA) has led to an increase in adverse
events owing to local soft-tissue reactions from metal ions and
wear debris. While the majority of these implants perform well,
it has been increasingly recognised that a small proportion of patients
may develop complications secondary to systemic cobalt toxicity
when these implants fail. However, distinguishing true toxicity
from benign elevations in cobalt ion levels can be challenging. The purpose of this two part series is to review the use of cobalt
alloys in THA and to highlight the following related topics of interest:
mechanisms of cobalt ion release and their measurement, definitions
of pathological cobalt ion levels, and the pathophysiology, risk factors
and treatment of cobalt toxicity. Historically, these metal-on-metal
arthroplasties are composed of a chromium-cobalt articulation. The release of cobalt is due to the mechanical and oxidative
stresses placed on the prosthetic joint. It exerts its pathological
effects through direct cellular toxicity. This manuscript will highlight the pathophysiology of cobalt
toxicity in patients with metal-on-metal hip arthroplasties. Take home message: Patients with new or evolving hip symptoms
with a prior history of THA warrant orthopaedic surgical evaluation.
Increased awareness of the range of systemic symptoms associated
with cobalt toxicity, coupled with prompt orthopaedic intervention, may
forestall the development of further complications. Cite this article:
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.