In 2015, we published the results of our ceramic-on-metal (CoM) total hip arthroplasties (THAs) performed between October 2007 and July 2009 with a mean follow-up of 34 months (23 to 45) and a revision rate of 3.1%. The aim of this paper is to present the longer-term outcomes. A total of 264 patients were reviewed at a mean of 5.8 years (4.6 to 7.2) and 10.1 years (9.2 to 10.6) to determine revision rate, pain, outcome scores, radiological analysis, and blood ion levels. Those who were unwilling or unable to travel were contacted by telephone.Aims
Methods
Hip resurfacing remains a potentially valuable surgical procedure for appropriately-selected patients with optimised implant choices. However, concern regarding high early failure rates continues to undermine confidence in use. A large contributor to failure is adverse local tissue reactions around metal-on-metal (MoM) bearing surfaces. Such phenomena have been well-explored around MoM total hip arthroplasties, but comparable data in equivalent hip resurfacing procedures is lacking. In order to define genetic predisposition, we performed a case-control study investigating the role of human leucocyte antigen (HLA) genotype in the development of pseudotumours around MoM hip resurfacings. A matched case-control study was performed using the prospectively-collected database at the host institution. In all, 16 MoM hip resurfacing 'cases' were identified as having symptomatic periprosthetic pseudotumours on preoperative metal artefact reduction sequence (MARS) MRI, and were subsequently histologically confirmed as high-grade aseptic lymphocyte-dominated vasculitis-associated lesions (ALVALs) at revision surgery. ‘Controls’ were matched by implant type in the absence of evidence of pseudotumour. Blood samples from all cases and controls were collected prospectively for high resolution genetic a nalysis targeting 11 separate HLA loci. Statistical significance was set at 0.10 a priori to determine the association between HLA genotype and pseudotumour formation, given the small sample size.Aims
Methods
Taper corrosion has been widely reported to be problematic for modular total hip arthroplasty implants. A simple and systematic method to evaluate taper damage with sufficient resolution is needed. We introduce a semiquantitative grading system for modular femoral tapers to characterize taper corrosion damage. After examining a unique collection of retrieved cobalt-chromium (CoCr) taper sleeves (n = 465) using the widely-used Goldberg system, we developed an expanded six-point visual grading system intended to characterize the severity, visible material loss, and absence of direct component contact due to corrosion. Female taper sleeve damage was evaluated by three blinded observers using the Goldberg scoring system and the expanded system. A subset (n = 85) was then re-evaluated following destructive cleaning, using both scoring systems. Material loss for this subset was quantified using metrology and correlated with both scoring systems.Aims
Methods
To establish the survivorship, function, and metal ion levels in an unselected series of metal-on-metal hip resurfacing arthroplasties (HRAs) performed by a non-designer surgeon. We reviewed 105 consecutive HRAs in 83 patients, performed by a single surgeon, at a mean follow-up of 14.9 years (9.3 to 19.1). The cohort included 45 male and 38 female patients, with a mean age of 49.5 years (SD 12.5)Aims
Methods
Elevated levels of circulating cobalt ions have been linked with a wide range of systemic complications including neurological, endocrine, and cardiovascular symptoms. Case reports of patients with elevated blood cobalt ions have described significant cardiovascular complications including cardiomyopathy. However, correlation between the actual level of circulating cobalt and extent of cardiovascular injury has not previously been performed. This review examines evidence from the literature for a link between elevated blood cobalt levels secondary to metal-on-metal (MoM) hip arthroplasties and cardiomyopathy. Correlation between low, moderate, and high blood cobalt with cardiovascular complications has been considered. Elevated blood cobalt at levels over 250 µg/l have been shown to be a risk factor for developing systemic complications and published case reports document cardiomyopathy, cardiac transplantation, and death in patients with severely elevated blood cobalt ions. However, it is not clear that there is a hard cut-off value and cardiac dysfunction may occur at lower levels. Clinical and laboratory research has found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. Further work needs to be done to clarify the link between severely elevated blood cobalt ions and cardiomyopathy. Cite this article:
Modern metal-on-metal (MoM) hip resurfacing arthroplasty (HRA), while achieving good results with well-orientated, well-designed components in ideal patients, is contraindicated in women, men with head size under 50 mm, or metal hypersensitivity. These patients currently have no access to the benefits of HRA. Highly crosslinked polyethylene (XLPE) has demonstrated clinical success in total hip arthroplasty (THA) and, when used in HRA, potentially reduces metal ion-related sequelae. We report the early performance of HRA using a direct-to-bone cementless mono-bloc XLPE component coupled with a cobalt-chrome femoral head, in the patient group for whom HRA is currently contraindicated. This is a cross-sectional, observational assessment of 88 consecutive metal-on-XLPE HRAs performed in 84 patients between 2015 and 2018 in three centres (three surgeons, including the designer surgeon). Mean follow-up is 1.6 years (0.7 to 3.9). Mean age at operation was 56 years (Objectives
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
The aim of this study was to determine whether patients with
metal-on-metal (MoM) arthroplasties of the hip have an increased
risk of cardiac failure compared with those with alternative types
of arthroplasties (non-MoM). A linkage study between the National Joint Registry, Hospital
Episodes Statistics and records of the Office for National Statistics
on deaths was undertaken. Patients who underwent elective total
hip arthroplasty between January 2003 and December 2014 with no
past history of cardiac failure were included and stratified as
having either a MoM (n = 53 529) or a non-MoM (n = 482 247) arthroplasty.
The primary outcome measure was the time to an admission to hospital
for cardiac failure or death. Analysis was carried out using data
from all patients and from those matched by propensity score.Aims
Patients and Methods
To determine ten-year failure rates following 36 mm metal-on-metal
(MoM) Pinnacle total hip arthroplasty (THA), and identify predictors
of failure. We retrospectively assessed a single-centre cohort of 569 primary
36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012
according to Medicines and Healthcare Products Regulation Agency
recommendations. All-cause failure rates (all-cause revision, and
non-revised cross-sectional imaging failures) were calculated, with predictors
for failure identified using multivariable Cox regression.Aims
Patients and Methods
Objectives. The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy
Alarm over the reported high failure rates for metal-on-metal (MoM) hip implants as well as their potential for locally aggressive Adverse Reactions to Metal Debris (ARMDs) has prompted government agencies, internationally, to recommend the monitoring of patients with MoM hip implants. Some have advised that a blood ion level >7 µg/L indicates potential for ARMDs. We report a systematic review and meta-analysis of the performance of metal ion testing for ARMDs. We searched MEDLINE and EMBASE to identify articles from which it was possible to reconstruct a 2 × 2 table. Two readers independently reviewed all articles and extracted data using explicit criteria. We computed a summary receiver operating curve using a Bayesian random-effects hierarchical model.Objectives
Methods
Objectives. This study aimed to characterise and qualitatively grade the severity of the corrosion particles released into the hip joint following taper corrosion. Methods. The 26 cases examined were CoC/ABG Modular (n = 13) and
Modular junctions are ubiquitous in contemporary hip arthroplasty. The head-trunnion junction is implicated in the failure of large diameter metal-on-metal (MoM) hips which are the currently the topic of one the largest legal actions in the history of orthopaedics (estimated costs are stated to exceed $4 billion). Several factors are known to influence the strength of these press-fit modular connections. However, the influence of different head sizes has not previously been investigated. The aim of the study was to establish whether the choice of head size influences the initial strength of the trunnion-head connection. Ti-6Al-4V trunnions (n = 60) and two different sizes of cobalt-chromium (Co-Cr) heads (28 mm and 36 mm; 30 of each size) were used in the study. Three different levels of assembly force were considered: 4 kN; 5 kN; and 6 kN (n = 10 each). The strength of the press-fit connection was subsequently evaluated by measuring the pull-off force required to break the connection. The statistical differences in pull-off force were examined using a Kruskal–Wallis test and two-sample Mann–Whitney U test. Finite element and analytical models were developed to understand the reasons for the experimentally observed differences.Objectives
Materials and Methods
High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015.Objectives
Methods
Arthroplasty registries are important for the
surveillance of joint replacements and the evaluation of outcome. Independent
validation of registry data ensures high quality. The ability for
orthopaedic implant retrieval centres to validate registry data
is not known. We analysed data from the National Joint Registry
for England, Wales and Northern Ireland (NJR) for primary metal-on-metal
hip arthroplasties performed between 2003 and 2013. Records were
linked to the London Implant Retrieval Centre (RC) for validation.
A total of 67 045 procedures on the NJR and 782 revised pairs of
components from the RC were included. We were able to link 476 procedures
(60.9%) recorded with the RC to the NJR successfully. However, 306
procedures (39.1%) could not be linked. The outcome recorded by the
NJR (as either revised, unrevised or death) for a primary procedure
was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval
linkage and correct assignment of outcome code improved over time.
The rates of error for component reference numbers on the NJR were
as follows: femoral head category number 14/229 (5.0%); femoral head
batch number 13/232 (5.3%); acetabular component category number
2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). Registry-retrieval linkage provided a novel means for the validation
of data, particularly for component fields. This study suggests
that NJR reports may underestimate rates of revision for many types
of metal-on-metal hip replacement. This is topical given the increasing
scope for NJR data. We recommend a system for continuous independent
evaluation of the quality and validity of NJR data. Cite this article:
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