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 rate and mode of early failure in 463 Birmingham hip resurfacings in a two-centre, multisurgeon series were examined. Of the 463 patients two have died and three were lost to follow-up. The mean radiological and clinical follow-up was for 43 months (6 to 90). We have revised 13 resurfacings (2.8%) including seven for pain, three for fracture, two for dislocation and another for sepsis. Of these, nine had macroscopic and histological evidence of metallosis. The survival at five years was 95.8% (95% confidence interval (CI) 94.1 to 96.8) for revision for all causes and 96.9% (95% CI 95.5 to 98.3) for metallosis. The rate of metallosis related revision was 3.1% at five years. Risk factors for metallosis were female gender, a small femoral component, a high abduction angle and obesity. We do not advocate the use of the Birmingham Hip resurfacing procedure in patients with these risk factors.
Adverse reaction to wear and corrosion debris
is a cause for concern in total hip arthroplasty (THA). Modular junctions
are a potential source of such wear products and are associated
with secondary pseudotumour formation. We present a consecutive series of 17 patients treated at our
unit for this complication following metal-on-highly cross-linked
polyethylene (MoP) THA. We emphasise the risk of misdiagnosis as
infection, and present the aggregate laboratory results and pathological
findings in this series. The clinical presentation was pain, swelling or instability.
Solid, cystic and mixed soft-tissue lesions were noted on imaging
and confirmed intra-operatively. Corrosion at the head–neck junction
was noted in all cases. No bacteria were isolated on multiple pre-
and intra-operative samples yet the mean erythrocyte sedimentation
rate was 49 (9 to 100) and C-reactive protein 32 (0.6 to 106) and
stromal polymorphonuclear cell counts were noted in nine cases. Adverse soft–tissue reactions can occur in MoP THA owing to corrosion
products released from the head–neck junction. The diagnosis should
be carefully considered when investigating pain after THA. This
may avoid the misdiagnosis of periprosthetic infection with an unidentified
organism and mitigate the unnecessary management of these cases
with complete single- or two-stage exchange. Cite this article:
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.
Surface hip replacement (SHR) is generally used
in younger, active patients as an alternative conventional total
hip replacement in part because of the ability to preserve femoral
bone. This major benefit of surface replacement will only hold true
if revision procedures of SHRs are found to provide good clinical
results. A retrospective review of SHR revisions between 2007 and 2012
was presented, and the type of revision and aetiologies were recorded.
There were 55 SHR revisions, of which 27 were in women. At a mean
follow-up of 2.3 years (0.72 to 6.4), the mean post-operative Harris
hip score (HHS) was 94.8 (66 to 100). Overall 23 were revised for mechanical
reasons, nine for impingement, 13 for metallosis, nine for unexplained
pain and one for sepsis. Of the type of revision surgery performed,
14 were femoral-only revisions; four were acetabular-only revisions,
and 37 were complete revisions. We did not find that clinical scores were significantly different
between gender or different types of revisions. However, the mean
post-operative HHS was significantly lower in patients revised for
unexplained pain compared with patients revised for mechanical reasons
(86.9 (66 to 100) Based on the overall clinical results, we believe that revision
of SHR can have good or excellent results and warrants a continued
use of the procedure in selected patients. Close monitoring of these
patients facilitates early intervention, as we believe that tissue
damage may be related to the duration of an ongoing problem. There
should be a low threshold to revise a surface replacement if there
is component malposition, rising metal ion levels, or evidence of
soft-tissue abnormalities. Cite this article:
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.
We report the clinical and radiological outcome at ten years of 104 primary total hip replacements (100 patients) using the Metasul metal-on-metal bearing. Of these, 52 had a cemented Stuehmer-Weber polyethylene acetabular component with a Metasul bearing and 52 had an uncemented Allofit acetabular component with a Metasul liner. A total of 15 patients (16 hips) died before their follow-up at ten years and three were lost to follow-up. The study group therefore comprised 82 patients (85 hips). The mean Oxford score at ten years was 20.7 (12 to 42). Six of 85 hips required revision surgery. One was performed because of infection, one for aseptic loosening of the acetabular component and four because of unexplained pain. Histological examination showed an aseptic lymphocytic vasculitis associated lesion-type tissue response in two of these. Continued follow-up is advocated in order to monitor the long-term performance of the Metasul bearing and tissue responses to metal debris.
A retrospective study was conducted to investigate
the changes in metal ion levels in a consecutive series of Birmingham
Hip Resurfacings (BHRs) at a minimum ten-year follow-up. We reviewed
250 BHRs implanted in 232 patients between 1998 and 2001. Implant
survival, clinical outcome (Harris hip score), radiographs and serum chromium
(Cr) and cobalt (Co) ion levels were assessed. Of 232 patients, 18 were dead (five bilateral BHRs), 15 lost
to follow-up and ten had been revised. The remaining 202 BHRs in
190 patients (136 men and 54 women; mean age at surgery 50.5 years
(17 to 76)) were evaluated at a minimum follow-up of ten years (mean
10.8 years (10 to 13.6)). The overall implant survival at 13.2 years
was 92.4% (95% confidence interval 90.8 to 94.0). The mean Harris
hip score was 97.7 (median 100; 65 to 100). Median and mean ion
levels were low for unilateral resurfacings (Cr: median 1.3 µg/l,
mean
1.95 µg/l (<
0.5 to 16.2); Co: median 1.0 µg/l, mean 1.62 µg/l
(<
0.5 to 17.3)) and bilateral resurfacings (Cr: median 3.2 µg/l,
mean 3.46 µg/l (<
0.5 to 10.0); Co: median 2.3 µg/l, mean 2.66
µg/l (<
0.5 to 9.5)). In 80 unilateral BHRs with sequential ion
measurements, Cr and Co levels were found to decrease significantly
(p <
0.001) from the initial assessment at a median of six years
(4 to 8) to the last assessment at a median of 11 years (9 to 13),
with a mean reduction of 1.24 µg/l for Cr and 0.88 µg/l for Co.
Three female patients had a >
2.5 µg/l increase of Co ions, associated with
head sizes ≤ 50 mm, clinical symptoms and osteolysis. Overall, there
was no significant difference in change of ion levels between genders
(Cr, p = 0.845; Co, p = 0.310) or component sizes (Cr, p = 0.505;
Co, p = 0.370). Higher acetabular component inclination angles correlated
with greater change in ion levels (Cr, p = 0.013; Co, p = 0.002).
Patients with increased ion levels had lower Harris hip scores (p
= 0.038). In conclusion, in well-functioning BHRs the metal ion levels
decreased significantly at ten years. An increase >
2.5 µg/l was
associated with poor function. Cite this article:
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.
Arthroscopy of the native hip is an established diagnostic and therapeutic procedure. Its application in the symptomatic replaced hip is still being explored. We describe the use of arthroscopy of the hip in 24 symptomatic patients following total hip replacement, resurfacing arthroplasty of the hip and partial resurfacing (study group), and compared it with arthroscopy of the native hip in 24 patients (control group). A diagnosis was made or confirmed at arthroscopy in 23 of the study group and a therapeutic arthroscopic intervention resulted in relief of symptoms in ten of these. In a further seven patients it led to revision hip replacement. In contrast, arthroscopy in the control group was diagnostic in all 24 patients and the resulting arthroscopic therapeutic intervention provided symptomatic relief in 21. The mean operative time in the study group (59.7 minutes (35 to 93)) was less than in the control group (71 minutes (40 to 100), p = 0.04) but the arthroscopic approach was more difficult in the arthroplasty group. We suggest that arthroscopy has a role in the management of patients with a symptomatic arthroplasty when other investigations have failed to provide a diagnosis.
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 blood metal ion levels and orientation of the acetabular component. There was no significant difference in metal ion levels (chromium, p = 0.82; cobalt, p = 0.40) or head wear rate (p = 0.14) between the two groups. The ASR had a significantly increased rate of wear of the acetabular component (p = 0.03) and a significantly increased occurrence of edge loading (p <
0.005), which can be attributed to differences in design between the ASR and BHR. The effects of differences in design on the
Abnormal wear of cobalt-containing metal-on-metal
joints is associated with inflammatory pseudotumours. Cobalt ions
activate human toll-like receptor 4 (TLR4), which normally responds
to bacterial lipopolysaccharide (LPS) in sepsis. Activation of TLR4
by LPS increases the expression of chemokines IL-8 and CXCL10, which
recruit leukocytes and activated T-cells, respectively. This study
was designed to determine whether cobalt induces a similar inflammatory
response to LPS by promoting the expression of IL-8 and CXCL10.
A human monocytic cell line, derived from acute monocytic leukaemia,
was treated with cobalt ions and expression of IL-8 and CXCL10 measured at
mRNA and protein levels. Cobalt-treated macrophages showed a 60-fold
increase in IL-8 mRNA, and an eightfold increase in production of
the mature chemokine (both p <
0.001); expression of the CXCL10
gene and protein was also significantly increased by cobalt (both
p <
0.001). Experiments were also performed in the presence of
CLI-095, a TLR4-specific antagonist which abrogated the cobalt-mediated
increase in IL-8 and CXCL10 expression. These findings suggest that cobalt ions induce inflammation similar
to that observed during sepsis by the simultaneous activation of
two TLR4-mediated signalling pathways. These pathways result in
increased production of IL-8 and CXCL10, and may be implicated in
pseudotumour formation following metal-on-metal replacement. Cite this article:
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:
The December 2013 Hip &
Pelvis Roundup360 looks at: Enhanced recovery works; Acetabular placement; Exercise better than rest in osteoarthritis patients; if Birmingham hip resurfacing is immune from pseudotumour; HIV and arthroplasty; Labral tears revisited; Prophylactic surgery for FAI; and Ceramics and impaction grafting
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 December 2012 Hip &
Pelvis Roundup360 looks at: swimming against the tide with resurfacing; hip impingement surgery; the relationship between obesity and co-morbidities and joint replacement infection; cemented hips; cross-linked polyethylene notching; whether cement is necessary in oncological arthroplasty; and how total hip replacement may result in weight gain.
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.
Peri-articular soft-tissue masses or ‘pseudotumours’
can occur after large-diameter metal-on-metal (MoM) resurfacing
of the hip and conventional total hip replacement (THR). Our aim
was to assess the incidence of pseudotumour formation and to identify
risk factors for their formation in a prospective cohort study. A total of 119 patients who underwent 120 MoM THRs with large-diameter
femoral heads between January 2005 and November 2007 were included
in the study. Outcome scores, serum metal ion levels, radiographs
and CT scans were obtained. Patients with symptoms or an identified
pseudotumour were offered MRI and an ultrasound-guided biopsy. There were 108 patients (109 hips) eligible for evaluation by
CT scan at a mean follow-up of 3.6 years (2.5 to 4.5); 42 patients
(39%) were diagnosed with a pseudotumour. The hips of 13 patients
(12%) were revised to a polyethylene acetabular component with small-diameter
metal head. Patients with elevated serum metal ion levels had a
four times increased risk of developing a pseudotumour. This study shows a substantially higher incidence of pseudotumour
formation and subsequent revisions in patients with MoM THRs than
previously reported. Because most revision cases were identified
only after an intensive screening protocol, we recommend close monitoring
of patients with MoM THR.
We report a systematic review and meta-analysis
of the peer-reviewed literature focusing on metal sensitivity testing
in patients undergoing total joint replacement (TJR). Our purpose
was to assess the risk of developing metal hypersensitivity post-operatively
and its relationship with outcome and to investigate the advantages
of performing hypersensitivity testing. We undertook a comprehensive search of the citations quoted in
PubMed and EMBASE: 22 articles (comprising 3634 patients) met the
inclusion criteria. The frequency of positive tests increased after
TJR, especially in patients with implant failure or a metal-on-metal
coupling. The probability of developing a metal allergy was higher
post-operatively (odds ratio (OR) 1.52 (95% confidence interval
(CI) 1.06 to 2.31)), and the risk was further increased when failed
implants were compared with stable TJRs (OR 2.76 (95% CI 1.14 to
6.70)). Hypersensitivity testing was not able to discriminate between
stable and failed TJRs, as its predictive value was not statistically
proven. However, it is generally thought that hypersensitivity testing
should be performed in patients with a history of metal allergy
and in failed TJRs, especially with metal-on-metal implants and
when the cause of the loosening is doubtful.
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.