The aim of this study was to investigate whether wear and backside deformation of polyethylene (PE) tibial inserts may influence the cement cover of tibial trays of explanted total knee arthroplasties (TKAs). At our retrieval centre, we measured changes in the wear and deformation of PE inserts using coordinate measuring machines and light microscopy. The amount of cement cover on the backside of tibial trays was quantified as a percentage of the total surface. The study involved data from the explanted fixed-bearing components of four widely used contemporary designs of TKA (Attune, NexGen, Press Fit Condylar (PFC), and Triathlon), revised for any indication, and we compared them with components that used previous generations of PE. Regression modelling was used to identify variables related to the amount of cement cover on the retrieved trays.Aims
Methods
Our primary aim was to describe migration of the Exeter stem with a 32 mm head on highly crosslinked polyethylene and whether this is influenced by age. Our secondary aims were to assess functional outcome, satisfaction, activity, and bone mineral density (BMD) according to age. A prospective cohort study was conducted. Patients were recruited into three age groups: less than 65 years (n = 65), 65 to 74 years (n = 68), and 75 years and older (n = 67). There were 200 patients enrolled in the study, of whom 115 were female and 85 were male, with a mean age of 69.9 years (sd 9.5, 42 to 92). They were assessed preoperatively, and at three, 12 and, 24 months postoperatively. Stem migration was assessed using Einzel-Bild-Röntgen-Analyse (EBRA). Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), EuroQol-5 domains questionnaire (EQ-5D), short form-36 questionnaire (SF-36,) and patient satisfaction were used to assess outcome. The Lower Extremity Activity Scale (LEAS), Timed Up and Go (TUG) test, and activPAL monitor (energy expelled, time lying/standing/walking and step count) were used to assess activity. The BMD was assessed in Gruen and Charnley zones.Objectives
Patients and Methods
We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr. For part A, we included all revision surgeries carried out at our unit with the relevant data, including volumetric wear analysis, joint fluid (JF) Co and Cr concentrations, and ALVAL grade (n = 315). Receiver operating characteristic curves were constructed to assess the reliability of the CoCr JFR in identifying severe ALVAL and/or SOTP. For part B, we included only patients with unilateral prostheses who had given matched serum and whole blood samples for Co and Cr analysis (n = 155). Multiple regression was used to examine the influence of JF concentrations on the serum partitioning of Co and Cr in the blood.Objectives
Methods
There are limited published data detailing the volumetric material loss from tapers of conventional metal-on-polyethylene (MoP) total hip arthroplasties (THAs). Our aim was to address this by comparing the taper wear rates measured in an explanted cohort of the widely used Exeter THA with those measured in a group of metal-on-metal (MoM) THAs. We examined an existing retrieval database to identify all Exeter V40 and Universal MoP THAs. Volumetric wear analysis of the taper surfaces was conducted using previously validated methodology. These values were compared with those obtained from a series of MoM THAs using non-parametric statistical methodology. A number of patient and device variables were accounted for using multiple regression modelling.Aims
Patients and Methods
We have encountered patients who developed large joint fluid collections with massive elevations in chromium (Cr) and cobalt (Co) concentrations following metal-on-metal (MoM) hip arthroplasties. In some cases, retrieval analysis determined that these ion concentrations could not be explained simply by the wear rates of the components. We hypothesized that these effects may be associated with aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL). We examined the influence of the ALVAL grade on synovial fluid Co and Cr concentrations following adjustment for patient and device variables, including volumetric wear rates. Initially restricting the analysis to include only patients with one MoM hip resurfacing device, we performed multiple regression analyses of prospectively collected data. We then repeated the same statistical approach using results from a larger cohort with different MoM designs, including total hip arthroplasties.Objectives
Patients and Methods
We sought to determine whether cobalt-chromium alloy (CoCr) femoral
stem tapers (trunnions) wear more than titanium (Ti) alloy stem
tapers (trunnions) when used in a large diameter (LD) metal-on-metal
(MoM) hip arthroplasty system. We performed explant analysis using validated methodology to
determine the volumetric material loss at the taper surfaces of
explanted LD CoCr MoM hip arthroplasties used with either a Ti alloy
(n = 28) or CoCr femoral stem (n = 21). Only 12/14 taper constructs
with a rough male taper surface and a nominal included angle close
to 5.666° were included. Multiple regression modelling was undertaken
using taper angle, taper roughness, bearing diameter (horizontal
lever arm) as independent variables. Material loss was mapped using
a coordinate measuring machine, profilometry and scanning electron
microscopy.Aims
Patients and Methods
The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces. In this study, a coordinate measuring machine (CMM) was used to measure the wear on five failed cementless Biomet Magnum/ReCap/ Taperloc large head MoM THAs, along with one Biomet ReCap resurfacing joint. Surface roughness measurements were also taken. The reason for revision of these implants was pain and/or adverse reaction to metal debris (ARMD) and/or elevated blood metal ion levels.Objectives
Methods
We wished to investigate the influence of metal debris exposure
on the subsequent immune response and resulting soft-tissue injury
following metal-on-metal (MoM) hip arthroplasty. Some reports have
suggested that debris generated from the head-neck taper junction
is more destructive than equivalent doses from metal bearing surfaces. We investigated the influence of the source and volume of metal
debris on chromium (Cr) and cobalt (Co) concentrations in corresponding
blood and hip synovial fluid samples and the observed agglomerated
particle sizes in excised tissues using multiple regression analysis
of prospectively collected data. A total of 199 explanted MoM hips
(177 patients; 132 hips female) were analysed to determine rates
of volumetric wear at the bearing surfaces and taper junctions. Aims
Patients and Methods
Wear debris released from bearing surfaces has been shown to
provoke negative immune responses in the recipient. Excessive wear
has been linked to early failure of prostheses. Analysis using coordinate
measuring machines (CMMs) can provide estimates of total volumetric
material loss of explanted prostheses and can help to understand
device failure. The accuracy of volumetric testing has been debated,
with some investigators stating that only protocols involving hundreds
of thousands of measurement points are sufficient. We looked to
examine this assumption and to apply the findings to the clinical
arena. We examined the effects on the calculated material loss from
a ceramic femoral head when different CMM scanning parameters were
used. Calculated wear volumes were compared with gold standard gravimetric
tests in a blinded study. Objectives
Methods
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
An ongoing prospective study to investigate failing metal-on-metal
hip prostheses was commenced at our centre in 2008. We report on
the results of the analysis of the first consecutive 126 failed
mated total hip prostheses from a single manufacturer. Analysis was carried out using highly accurate coordinate measuring
to calculate volumetric and linear rates of the articular bearing
surfaces and also the surfaces of the taper junctions. The relationship
between taper wear rates and a number of variables, including bearing
diameter and orientation of the acetabular component, was investigated.Objectives
Methods
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.
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.
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.
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.
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.
There have been no large comparative studies of the blood levels of metal ions after implantation of commercially available hip resurfacing devices which have taken into account the effects of femoral size and inclination and anteversion of the acetabular component. We present the results in 90 patients with unilateral articular surface replacement (ASR) hip resurfacings (mean time to blood sampling 26 months) and 70 patients with unilateral Birmingham Hip Resurfacing (BHR) implants (mean time 47 months). The whole blood and serum chromium (Cr) and cobalt (Co) concentrations were inversely related to the size of the femoral component in both groups (p <
0.05). Cr and Co were more strongly influenced by the position of the acetabular component in the case of the ASR, with an increase in metal ions observed at inclinations >
45° and anteversion angles of <
10° and >
20°. These levels were only increased in the BHR group when the acetabular component was implanted with an inclination >
55°. A significant relationship was identified between the anteversion of the BHR acetabular component and the levels of Cr and Co (p <
0.05 for Co), with an increase observed at anteversion angles <
10° and >
20°. The median whole blood and serum Cr concentrations of the male ASR patients were significantly lower than those of the BHR men (p <
0.001). This indicates that reduced diametral clearance may equate to a reduction in metal ion concentrations in larger joints with satisfactory orientation of the acetabular component.
Increased concentrations of metal ions after metal-on-metal resurfacing arthroplasty of the hip remain a concern. Although there has been no proven link to long-term health problems or early prosthetic failure, variables associated with high metal ion concentrations should be identified and, if possible, corrected. Our study provides data on metal ion levels from a series of 76 consecutive patients (76 hips) after resurfacing arthroplasty with the Articular Surface Replacement. Chromium and cobalt ion concentrations in the whole blood of patients with smaller (≤ 51 mm) femoral components were significantly higher than in those with the larger (≥ 53 mm) components (p <
0.01). Ion concentrations in the former group were significantly related to the inclination (p = 0.01) and anteversion (p = 0.01) of the acetabular component. The same relationships were not significant in the patients with larger femoral components (p = 0.61 and p = 0.49, respectively). Accurate positioning of the acetabular component intra-operatively is essential in order to reduce the concentration of metal ions in the blood after hip resurfacing arthroplasty with the Articular Surface Replacement implant.
