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:
We present a case series of ten metal-on-polyethylene total hip
arthroplasties (MoP THAs) with delayed dislocation associated with
unrecognised adverse local tissue reaction due to corrosion at the
trunnion and pseudotumour formation. The diagnosis was not suspected in nine of the ten patients (six
female/four male; mean age 66 years), despite treatment in a specialist
unit (mean time from index surgery to revision was 58 months, 36
to 84). It was identified at revision surgery and subsequently confirmed
by histological examination of resected tissue. Pre-operative assessment
and culture results ruled out infection. A variety of treatment
strategies were used, including resection of the pseudotumour and
efforts to avoid recurrent dislocation. Aims
Methods
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.
The popularity of cementless total hip replacement
(THR) has surpassed cemented THR in England and Wales. This retrospective
cohort study records survival time to revision following primary
cementless THR with the most common combination (accounting for
almost a third of all cementless THRs), and explores risk factors independently
associated with failure, using data from the National Joint Registry
for England and Wales. Patients with osteoarthritis who had a DePuy
Corail/Pinnacle THR implanted between the establishment of the registry
in 2003 and 31 December 2010 were included within analyses. There
were 35 386 procedures. Cox proportional hazard models were used
to analyse the extent to which the risk of revision was related
to patient, surgeon and implant covariates. The overall rate of
revision at five years was 2.4% (99% confidence interval 2.02 to
2.79). In the final adjusted model, we found that the risk of revision
was significantly higher in patients receiving metal-on-metal (MoM:
hazard ratio (HR) 1.93, p <
0.001) and ceramic-on-ceramic bearings
(CoC: HR 1.55, p = 0.003) compared with the best performing bearing
(metal-on-polyethylene). The risk of revision was also greater for
smaller femoral stems (sizes 8 to 10: HR 1.82, p <
0.001) compared
with mid-range sizes. In a secondary analysis of only patients where body
mass index (BMI) data were available (n = 17 166), BMI ≥ 30 kg/m2 significantly
increased the risk of revision (HR 1.55, p = 0.002). The influence
of the bearing on the risk of revision remained significant (MoM:
HR 2.19, p <
0.001; CoC: HR 2.09,
p = 0.001). The risk of revision was independent of age, gender,
head size and offset, shell, liner and stem type, and surgeon characteristics. We found significant differences in failure between bearing surfaces
and femoral stem size after adjustment for a range of covariates
in a large cohort of single-brand cementless THRs. In this study
of procedures performed since 2003, hard bearings had significantly
higher rates of revision, but we found no evidence that head size
had an effect. Patient characteristics, such as BMI and American
Society of Anesthesiologists grade, also influence the survival
of cementless components. Cite this article:
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 prospectively assessed the efficacy of a ceramic-on-metal
(CoM) hip bearing with uncemented acetabular and femoral components
in which cobalt–chrome acetabular liners and alumina ceramic heads
were used. The cohort comprised 94 total hip replacements (THRs) in 83 patients
(38 women and 45 men) with a mean age of 58 years (42 to 70). Minimum
follow-up was two years. All patients had pre- and post-operative
assessment using the Western Ontario and McMaster Universities osteoarthritis
index (WOMAC), Oxford hip score and Short-Form 12 scores. All showed
a statistically significant improvement from three months post-operatively
onwards (all p <
0.001). After two years whole blood metal ion levels were measured and
chromosomal analysis was performed. The levels of all metal ions
were elevated except vanadium. Levels of chromium, cobalt, molybdenum
and titanium were significantly higher in patients who underwent
bilateral THR compared with those undergoing unilateral THR (p <
0.001).
Chromosomal analysis demonstrated both structural and aneuploidy
mutations. There were significantly more breaks and losses than
in the normal population (p <
0.001). There was no significant
difference in chromosomal aberration between those undergoing unilateral
and bilateral procedures (all analyses p ≥ 0.62). The use of a CoM THR is effective clinically in the short-term,
with no concerns, but the significance of high metal ion levels
and chromosomal aberrations in the long-term remains unclear. Cite this article:
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
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.
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.
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.
Metal-on-metal hip arthroplasty gained significant
favor in the first decade of the millennium. However, the past several
years have seen increasing reports of failure, pseudotumor and other
adverse reactions. This study presents the results of a single center’s
15-year experience with metal-on-metal total hip arthroplasty as
strong evidence that metal-on-metal is going, going, gone.
Hip resurfacing has been proposed as an alternative
to traditional total hip arthroplasty in young, active patients.
Much has been learned following the introduction of metal-on-metal resurfacing
devices in the 1990s. The triad of a well-designed device, implanted
accurately, in the correct patient has never been more critical
than with these implants. Following Food and Drug Administration approval in 2006, we studied
the safety and effectiveness of one hip resurfacing device (Birmingham
Hip Resurfacing) at our hospital in a large, single-surgeon series.
We report our early to mid–term results in 1333 cases followed for
a mean of 4.3 years (2 to 5.7) using a prospective, observational
registry. The mean patient age was 53.1 years (12 to 84); 70% were
male and 91% had osteoarthritis. Complications were few, including
no dislocations, no femoral component loosening, two femoral neck
fractures (0.15%), one socket loosening (0.08%), three deep infections
(0.23%), and three cases of metallosis (0.23%). There were no destructive
pseudotumours. Overall survivorship at up to 5.7 years was 99.2%. Aseptic survivorship
in males under the age of 50 was 100%. We believe this is the largest
United States series of a single surgeon using a single resurfacing
system. Cite this article:
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:
The purpose of this study was to evaluate whether concerns about the release of metal ions in metal-on-metal total hip replacements (THR) should be extended to patients with metal-bearing total disc replacements (TDR). Cobalt and chromium levels in whole blood and serum were measured in ten patients with a single-level TDR after a mean follow-up of 34.5 months (13 to 61) using inductively-coupled plasma mass spectrometry. These metal ion levels were compared with pre-operative control levels in 81 patients and with metal ion levels 12 months after metal-on-metal THR (n = 21) and resurfacing hip replacement (n = 36). Flexion-extension radiographs were used to verify movement of the TDR. Cobalt levels in whole blood and serum were significantly lower in the TDR group than in either the THR (p = 0.007) or the resurfacing group (p <
0.001). Both chromium levels were also significantly lower after TDR These results suggest that there is minimal cause for concern about high metal ion concentrations after TDR, as the levels appear to be only moderately elevated. However, spinal surgeons using a metal-on-metal TDR should still be aware of concerns expressed in the hip replacement literature about toxicity from elevated metal ion levels, and inform their patients appropriately.
Ceramic-on-ceramic (CoC) bearings in total hip arthroplasty (THA)
are commonly used, but concerns exist regarding ceramic fracture.
This study aims to report the risk of revision for fracture of modern
CoC bearings and identify factors that might influence this risk,
using data from the National Joint Registry (NJR) for England, Wales, Northern
Ireland and the Isle of Man. We analysed data on 223 362 bearings from 111 681 primary CoC
THAs and 182 linked revisions for bearing fracture recorded in the
NJR. We used implant codes to identify ceramic bearing composition
and generated Kaplan-Meier estimates for implant survivorship. Logistic
regression analyses were performed for implant size and patient specific
variables to determine any associated risks for revision.Aims
Patients and Methods
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.
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.
The December 2015 Hip &
Pelvis Roundup360 looks at: Vitamin E infusion helpful in polyethylene; Hip replacement in fracture and arthritis; Non-surgical treatment for arthritis; Cost and approach in hip surgery; Who does well in FAI surgery?; AAOS Thromboembolism guidelines; Thromboprophylaxis and periprosthetic joint infection; Fluid collections not limited to metal-on-metal THR