Aims. A recent report from France suggested an association between the use of cobalt-chrome (CoCr) femoral heads in total hip arthroplasties (THAs) and an increased risk of dilated cardiomyopathy and heart failure. CoCr is a commonly used material in orthopaedic implants. If the reported association is causal, the consequences would be significant given the millions of joint arthroplasties and other orthopaedic procedures in which CoCr is used annually. We examined whether CoCr-containing THAs were associated with an increased risk of all-cause mortality, heart outcomes, cancer, and neurodegenerative disorders in a large national database. Methods. Data from the National Joint Registry was linked to NHS English hospital inpatient episodes for 374,359 primary THAs with up to 14.5 years' follow-up. We excluded any patients with bilateral THAs, knee arthroplasties, indications other than osteoarthritis, aged under 55 years, and diagnosis of one or more outcome of interest before THA. Implants were grouped as either containing CoCr or not containing CoCr. The association between implant construct and the risk of all-cause mortality and incident heart failure, cancer, and neurodegenerative disorders was examined. Results. There were 158,677 individuals (42.4%) with an implant containing CoCr. There were 47,963 deaths, 27,332 heart outcomes, 35,720 cancers, and 22,025 neurodegenerative disorders. There was no evidence of an association between patients with CoCr implants and higher rates of any of the outcomes. Conclusion. CoCr-containing THAs did not have an increased risk of all-cause mortality, or clinically meaningful heart outcomes, cancer, or neurodegenerative disorders into the second decade post-implantation. Our findings will help reassure clinicians and the increasing number of patients receiving primary THA worldwide that the use of CoCr-containing implants is not associated with significant adverse
Aims. Osteolysis, secondary to local and
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
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
As adverse events related to metal on metal hip
arthroplasty have been better understood, there has been increased
interest in toxicity related to the high circulating levels of cobalt ions.
However, distinguishing true toxicity from benign elevations in
cobalt levels can be challenging. The purpose of this review is
to examine the use of cobalt alloys in total hip arthroplasty, to
review the methods of measuring circulating cobalt levels, to define
a level of cobalt which is considered pathological and to review
the pathophysiology, risk factors and treatment of cobalt toxicity.
To the best of our knowledge, there are 18 published cases where
cobalt metal ion toxicity has been attributed to the use of cobalt-chromium
alloys in hip arthroplasty. Of these cases, the great majority reported
systemic toxic reactions at serum cobalt levels more than 100 μg/L.
This review highlights some of the clinical features of cobalt toxicity,
with the goal that early awareness may decrease the risk factors
for the development of cobalt toxicity and/or reduce its severity. Take home message: Severe adverse events can arise from the release
of cobalt from metal-on-metal arthroplasties, and as such, orthopaedic
surgeons should not only be aware of the presenting problems, but
also have the knowledge to treat appropriately. Cite this article:
Post-operative migration of cemented acetabular components as
measured by radiostereometric analysis (RSA) has a strong predictive
power for late, aseptic loosening. Also, radiolucent lines predict
late loosening. Migration has been reduced by systemic bisphosphonate
treatment in randomised trials of hip and knee arthroplasty. Used
as a local treatment, a higher local dose of bisphosphonate can
be achieved without systemic exposure. We wished to see if this
principle could be applied usefully in total hip arthroplasty (THA). In this randomised placebo-controlled, double-blinded trial with
60 participants, we compressed gauze soaked in bisphosphonate solution
(ibandronate) or saline against the acetabular bone bed immediately
before cementing the acetabular component. RSA, classification of
radiolucent lines, the Harris Hip Score (HHS) and the Western Ontario McMasters
Universities Osteoarthritis Index (WOMAC) were carried out at three-,
six-, 12-, and 24-month follow-up.Aims
Patients and Methods
The long term biological effects of wear products
following total hip arthroplasty (THA) are unclear. However, the indications
for THA are expanding, with increasingly younger patients undergoing
the procedure. This prospective, randomised study compared two groups of patients
undergoing THA after being randomised to receive one of two different
bearing surfaces: metal-on-polyethylene (MoP) n = 22 and metal-on-metal
(MoM) n = 23. We investigated the relationship between three variables:
bearing surface (MoP Our results demonstrated significantly higher mean cobalt and
chromium (Co and Cr) blood levels in the MoM group at all follow-up
points following surgery (p <
0.01), but there were no significant
differences in the chromosomal aberration indices between MoM and
MoP at two or five years (two years: p = 0.56, p = 0.08, p = 0.91, p
= 0.51 and five years: p = 0.086, p = 0.73, p = 0.06, p = 0.34)
for translocations, breaks, loss and gain of chromosomes respectively.
Regression analysis showed a strong linear relationship between
Cr levels and the total chromosomal aberration indices in the MoM
group (R2 = 0.90016), but this was not as strong for
Co (R2 = 0.68991). In the MoP group, the analysis revealed
a poor relationship between Cr levels and the total chromosomal
aberration indices (R2 = 0.23908) but a slightly stronger
relationship for Co (R2 = 0.64292). Across both groups,
Spearman’s correlation detected no overall association between Co and Cr
levels and each of the studied chromosomal aberrations. There remains
no clear indication which THA bearing couple is the most biocompatible,
especially in young active patients. While THA continues to be very
successful at alleviating pain and restoring function, the long-term
biological implications of the procedure still require further scrutiny. Cite this article:
Ceramic-on-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:
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:
Symptomatic cobalt toxicity from a failed total
hip replacement is a rare but devastating complication. It has been reported
following revision of fractured ceramic components, as well as in
patients with failed metal-on-metal articulations. Potential clinical
findings include fatigue, weakness, hypothyroidism, cardiomyopathy,
polycythaemia, visual and hearing impairment, cognitive dysfunction,
and neuropathy. We report a case of an otherwise healthy 46-year-old
patient, who developed progressively worsening symptoms of cobalt
toxicity beginning approximately six months following synovectomy
and revision of a fractured ceramic-on-ceramic total hip replacement
to a metal-on-polyethylene bearing. The whole blood cobalt levels
peaked at 6521 µg/l. The patient died from cobalt-induced cardiomyopathy.
Implant retrieval analysis confirmed a loss of 28.3 g mass of the
cobalt–chromium femoral head as a result of severe abrasive wear
by ceramic particles embedded in the revision polyethylene liner.
Autopsy findings were consistent with heavy metal-induced cardiomyopathy. We recommend using new ceramics at revision to minimise the risk
of wear-related cobalt toxicity following breakage of ceramic components. Cite this article:
We present the clinical results and survivorship
of consecutive 100 Birmingham Hip Resurfacings in 90 patients at
a minimum follow-up of ten years. All procedures were carried out
by an independent surgeon who commenced a prospective study in 1998.
Patients were assessed clinically using the Western Ontario and
McMaster Universities osteoarthritis index, Short-Form 36, Harris
hip score and University of California, Los Angeles activity score. Radiological
analysis was performed by an independent observer and blood metal
ion levels concentrations were measured at ten years post-operatively
in 62 patients. The median acetabular component inclination was
46.2° (34° to 59°) and anteversion 11.0° (0° to 30°). The median
chromium concentration in the unilateral group was 1.74 (0.41 to
15.23) and for the bilateral group was 2.98 (1.57 to 18.01). The
equivalent values for cobalt were 1.67 (0.54 to 20.4) and 1.88 (1.38
to 19.32). In total there were eight failures giving an overall survival
at ten years of 92% (95% confidence interval (CI) 86.7 to 97.3).
BHR in male patients had an improved survivorship of 94.6% (95%
CI 89.4 to 100) compared with females at 84.6% (95% CI 70.7 to 98.5),
but this did not reach statistical significance (p = 0.119). Four
of the nine BHRs with a bearing diameter of 42 mm failed. The overall results were consistent with data produced from other
centres in that the clinical outcome of large male patients was
extremely encouraging, whereas the survival of the smaller joints
was less satisfactory.
We report serum metal ion level data in patients with unilateral and bilateral hip resurfacing over a ten-year period. In these patients there is an increase in both cobalt and chromium levels above the accepted reference ranges during the first 18 months after operation. Metal ion levels remain elevated, but decline slowly for up to five years. However, the levels then appear to start rising again in some patients up to the ten-year mark. There was no significant difference in cobalt or chromium levels between men and women. These findings appear to differ from much of the current literature. The clinical significance of a raised metal ion level remains under investigation.
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.
We undertook a randomised controlled trial to
compare bipolar hemiarthroplasty (HA) with a novel total hip replacement
(THR) comprising a polycarbonate–urethane (PCU) acetabular component
coupled with a large-diameter metal femoral head for the treatment
of displaced fractures of the femoral neck in elderly patients. Functional
outcome, assessed with the Harris hip score (HHS) at three months
and then annually after surgery, was the primary endpoint. Rates
of revision and complication were secondary endpoints. Based on a power analysis, 96 consecutive patients aged >
70
years were randomised to receive either HA (49) or a PCU-THR (47).
The mean follow-up was 30.1 months (23 to 50) and 28.6 months (22
to 52) for the HA and the PCU group, respectively. The HHS showed no statistically significant difference between
the groups at every follow-up. Higher pain was recorded in the PCU
group at one and two years’ follow-up
(p = 0.006 and p = 0.019, respectively). In the HA group no revision
was performed. In the PCU-THR group six patients underwent revision
and one patient is currently awaiting
re-operation. The three-year survival rate of the PCU-THR group
was 0.841 (95% confidence interval 0.680 to 0.926). Based on our findings we do not recommend the use of the PCU
acetabular component as part of the treatment of patients with fractures
of the femoral neck. Cite this article:
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 ASR implant has a lower diametrical clearance and a subhemispherical acetabular component when compared with other more frequently implanted metal-on-metal hip resurfacings. These changes may contribute to the higher failure rate than in other series, compared with other designs. Given our poor results with the small components we are no longer implanting the smaller size.
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.
Modern metal-on-metal bearings produce less wear debris and osteolysis, but have the potential adverse effect of release of ions. Improved ceramic-on-ceramic bearings have the lowest wear of all, but the corrosion process has not been analysed. Our aim was to measure the serum ion release (ng/ml) in 23 patients having stable hip prostheses with a ceramic-on-ceramic coupling (group A) and to compare it with the release in 42 patients with a metal-on-metal bearing (group B) in the medium term. Reference values were obtained from a population of 47 healthy subjects (group C). The concentrations of chromium, cobalt, aluminium and titanium were measured. There was a significant increase of cobalt, chromium and aluminium levels (p <
0.05) in group B compared with groups A and C. Group A did not differ significantly from the control group. Despite the apparent advantage of a metal-on-metal coupling, especially in younger patients with a long life expectancy, a major concern arises regarding the extent and duration of ion exposure. For this reason, the low corrosion level in a ceramic-on-ceramic coupling could be advantageous.
We describe the experience with the first consecutive 230 Birmingham hip resurfacings at our centre. At a mean follow-up of three years (25 to 52 months) survivorship was 99.14% with revision in one patient for a loose acetabular component and one death from unrelated causes. One patient developed a fracture of the femoral neck at six weeks which united unremarkably after a period of non-weight-bearing. The Harris hip score improved from a mean of 62.54 (8 to 92) to 97.74 (61 to 100). The mean flexion improved from 91.52° (25 to 140) to 110.41° (80 to 145). Most patients (97%) considered the outcome to be good or excellent. Our preliminary experience with this implant is encouraging and the results are superior to the earlier generation of resurfacings for the same length of follow-up.