Metal-on-metal hip resurfacing is commonly performed for osteoarthritis in young active patients. We have observed cystic or solid masses, which we have called inflammatory pseudotumours, arising around these devices. They may cause soft-tissue destruction with severe symptoms and a poor outcome after revision surgery. The aim of this study was to determine the incidence of and risk factors for pseudotumours that are serious enough to require revision surgery. Since 1999, 1419 metal-on-metal hip resurfacings have been implanted by our group in 1224 patients; 1.8% of the patients had a revision for pseudotumour. In this series the Kaplan-Meier cumulative revision rate for pseudotumour increased progressively with time. At eight years, in all patients, it was 4% (95% confidence interval (CI) 2.2 to 5.8). Factors significantly associated with an increase in revision rate were female gender (p <
0.001), age under 40 (p = 0.003), small components (p = 0.003), and dysplasia (p = 0.019), whereas implant type was not (p = 0.156). These factors were inter-related, however, and on fitting a Cox proportional hazard model only gender (p = 0.002) and age (p = 0.024) had a significant independent influence on revision rate; size nearly reached significance (p = 0.08). Subdividing the cohort according to significant factors, we found that the revision rate for pseudotumours in men was 0.5% (95% CI 0 to 1.1) at eight years wheras in women over 40 years old it was 6% (95% CI 2.3 to 10.1) at eight years and in women under 40 years it was 13.1% at six years (95% CI 0 to 27) (p <
0.001). We recommend that resurfacings are undertaken with caution in women, particularly those under 40 years of age but they remain a good option in young men. Further work is required to understand the aetiology of pseudotumours so that this complication can be avoided.
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.
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.
This study reports the mid-term results of a large-bearing hybrid metal-on-metal total hip replacement in 199 hips (185 patients) with a mean follow-up of 62 months (32 to 83). Two patients died of unrelated causes and 13 were lost to follow-up. In all, 17 hips (8.5%) have undergone revision, and a further 14 are awaiting surgery. All revisions were symptomatic. Of the revision cases, 14 hips showed evidence of adverse reactions to metal debris. The patients revised or awaiting revision had significantly higher whole blood cobalt ion levels (p = 0.001), but no significant difference in acetabular component size or position compared with the unrevised patients. Wear analysis (n = 5) showed increased wear at the trunnion-head interface, normal levels of wear at the articulating surfaces and evidence of corrosion on the surface of the stem. The cumulative survival rate, with revision for any reason, was 92.4% (95% confidence interval 87.4 to 95.4) at five years. Including those awaiting surgery, the revision rate would be 15.1% with a cumulative survival at five years of 89.6% (95% confidence interval 83.9 to 93.4). This hybrid metal-on-metal total hip replacement series has shown an unacceptably high rate of failure, with evidence of high wear at the trunnion-head interface and passive corrosion of the stem surface. This raises concerns about the use of large heads on conventional 12/14 tapers.
Fracture of the neck of the femur after resurfacing arthroplasty usually leads to failure and conversion to a total hip replacement. We describe an intracapsular fracture of the femoral neck sustained after hip resurfacing which was treated by cannulated screws, resulting in union and retention of the resurfacing implant. The result at follow-up three years later was very satisfactory with a Harris hip score of 99.
The June 2014 Oncology Roundup360 looks at: Infection still a problem in endoprosthetic reconstruction; massive allografts not as successful as we perhaps think; curopsy for aneurysmal bone cysts?; lengthening prosthesis: days are numbered; new WHO classification in brief; proximal tumours and fluid levels: bad news; infection is predictable in orthopaedic oncology; psychosocial support key in oncological outcomes.
The open blast fracture of the pelvis is considered
to be the most severe injury within the spectrum of battlefield trauma.
We report our experience of 29 consecutive patients who had sustained
this injury in Afghanistan between 2008 and 2010. Their median new
injury severity score (NISS) was 41 (8 to 75), and mean blood requirement
in the first 24 hours was 60.3 units (0 to 224). In addition to
their orthopaedic injury, six had an associated vascular injury, seven
had a bowel injury, 11 had a genital injury and seven had a bladder
injury. In all, eight fractures were managed definitively with external
fixation and seven required internal fixation. Of those patients
who underwent internal fixation, four required removal of metalwork
for infection. Faecal diversion was performed in nine cases. The
median length of hospital stay following emergency repatriation
to the United Kingdom was 70.5 days (5 to 357) and the mean total
operating time was 29.6 hours (5 to 187). At a mean follow-up of
20.3 months (13.2 to 29.9), 24 patients (82.8%) were able to walk
and 26 (89.7%) had clinical and radiological evidence of stability
of the pelvic ring. As a result of the increase in terrorism, injuries that were
previously confined exclusively to warfare can now occur anywhere,
with civilian surgeons who are involved in trauma care potentially
required to manage similar injuries. Our study demonstrates that
the management of this injury pattern demands huge resources and significant
multidisciplinary input. Given the nature of the soft-tissue injury,
we would advocate external fixation as the preferred management
of these fractures. With the advent of emerging wound and faecal
management techniques, we do not believe that faecal diversion is
necessary in all cases.
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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.
Pseudotumours (abnormal peri-prosthetic soft-tissue reactions)
following metal-on-metal hip resurfacing arthroplasty (MoMHRA) have
been associated with elevated metal ion levels, suggesting that
excessive wear may occur due to edge-loading of these MoM implants.
This study aimed to quantify The duration and magnitude of edge-loading Objectives
Methods
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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.
We reviewed the outcome of patients who had been
treated operatively for symptomatic peri-acetabular metastases and
present an algorithm to guide treatment. The records of 81 patients who had been treated operatively for
symptomatic peri-acetabular metastases between 1987 and 2010 were
identified. There were 27 men and 54 women with a mean age of 61
years (15 to 87). The diagnosis, size of lesion, degree of pelvic
continuity, type of reconstruction, World Health Organization performance
status, survival time, pain, mobility and complications including
implant failure were recorded in each case. The overall patient survivorship at five years was 5%. The longest
lived patient survived 16 years from the date of diagnosis. The
mean survival was 23 months (<
1 to 16 years) and the median
was 15 months. At follow-up 14 patients remained alive. Two cementoplasties
failed because of local disease progression. Three Harrington rods broke:
one patient needed a subsequent Girdlestone procedure. One ‘ice-cream
cone’ prosthesis dislocated and was subsequently revised without
further problems. We recommend the ‘ice-cream cone’ for pelvic discontinuity
and Harrington rod reconstruction for severe bone loss. Smaller
defects can be safely managed using standard revision hip techniques. Cite this article:
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 ASR resurfacing and of 48.8% for the ASR total hip replacement (THR). Of 257 patients with a minimum follow-up of two years, 67 (26.1%) had a serum cobalt concentration which was greater than 7 μg/l. Co-ordinate measuring machine analysis of revised components showed that all patients suffering adverse tissue reactions in the resurfacing group had abnormal wear of the bearing surfaces. Six THR patients had relatively low rates of articular wear, but were found to have considerable damage at the trunion-taper interface. Our results suggest that wear at the modular junction is an important factor in the development of adverse tissue reactions after implantation of a large-diameter MoM THR.
We evaluated the concentrations of chromium and cobalt ions in blood after metal-on-metal surface replacement arthroplasty using a wrought-forged, high carbon content chromium-cobalt alloy implant in 64 patients. At one year, mean whole blood ion levels were 1.61 μg/L (0.4 to 5.5) for chromium and 0.67 μg/L (0.23 to 2.09) for cobalt. The pre-operative ion levels, component size, female gender and the inclination of the acetabular component were inversely proportional to the values of chromium and/or cobalt ions at one year postoperatively. Other factors, such as age and level of activity, did not correlate with the levels of metal ions. We found that the levels of the ions in the serum were 1.39 and 1.37 times higher for chromium and cobalt respectively than those in the whole blood. The levels of metal ions obtained may be specific to the hip resurfacing implant and reflect its manufacturing process.
Wear of metal-on-metal bearings causes elevated levels of cobalt and chromium in blood and body fluids. Metal-on-metal bearings have two distinct wear phases. In the early phase, the wear rate is high. Later, it decreases and the bearing enters a steady-state phase. It is expected that as the wear rates decline, the level of cobalt detected in plasma will also decrease. We studied the baseline and exercise-related cobalt rise in 21 patients (13 men and eight women) with a mean age of 54 years (38 to 80) who had undergone successful hip resurfacing at a mean of 44 months (10 to 96) earlier. Our results showed that circulating baseline cobalt levels were not significantly correlated with the time since implantation (r = 0.08, p = 0.650). By contrast, the exercise-related cobalt rise was directly correlated with the inclination angle of the acetabular component (r = 0.47, p = 0.032) and inversely correlated with the time since implantation (r = −0.5, p = 0.020). Inclination of the acetabular component should be kept less than 40° to decrease the production of wear debris.