Objectives. 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
Aims. The National Joint Registry for England, Wales and Northern Ireland
(NJR) has extended its scope to report on hospital, surgeon and
implant performance. Data linkage of the NJR to the London Implant
Retrieval Centre (LIRC) has previously evaluated data quality for
hip primary procedures, but did not assess revision records. . Methods. We analysed
Introduction. The National Joint Registry (NJR) for England, Wales and Northern Ireland contributes important information on the performance of implants and surgeons. However, the quality of this data is not known. This study aimed to perform an independent validation of primary
Purpose This study aims to investigate blood flow in the femoral head during
This study aims to investigate femoral blood flow during
In 1997 the Birmingham Hip Resurfacing was introduced to address the needs of young active patients. Alternative designs were introduced to try and improve wear performance. The aim of this study was a comparative cohort study of two types of metal-on-metal bearing to determine the mechanism of failure at 15 years. The study reviewed 91 Brimingham Hip Resurfacings (BHR) (Smith and Nephew) and 715 DUROM hip resurfacing (Zimmer) procedures in prior to 2009. Failure was defined as revision of either component for any reason. Kaplan-Meyer survivorship analysis performed. Routine follow-up with serum metal ion levels and radiographs. Mean follow-up was 17.9 years (range 15.2 – 25.1). The mean age at operation was 51.6 years (SD 8.6, range 20.7 to 70.2), including 299 women (37.1%). The Birmingham resurfacing demonstrated 92.3% survivorship at 15 years (SE 2.8, 95% CI 3.9 – 7.8) and 90.0% at latest follow-up (SE 3.5, 95% CI 4.9 to 9.4). By comparison, the DUROM survivorship at 15 years was 89.1% at 15 years (SE 1.2, 95% CI 2.0 to 2.5) and 87.4% (SE 1.3, 95% CI 2.5 to 2.3) at latest follow-up. There was no statistically significant difference in survivorship between groups (p= 0.32). Survival in male patients was 92.7% compared to 80.0% in females. The reported failures occurred from Adverse Reaction to Metal Debris (32 patients), periprosthetic femoral neck fracture (6) and aseptic loosening (41), PJI (12) and undiagnosed pain (6). The mean cobalt and chromium levels at last follow-up were 33.4 nmol/L and 36.5 nmol/L respectively. This study demonstrates two differently designed metal-on-metal hip resurfacing provided a durable alternative to total hip replacement, particularly in younger male patients with osteoarthritis. Differences in design did determine the reason for revision with acetabular fixation being one of the principal failure mechanisms for the DUROM compared to elevated ion levels.
Elevated blood cobalt secondary to metal-on-metal (MoM) hip arthroplasties has been shown to be a risk factor for developing cardiovascular complications including cardiomyopathy. Published case reports document cardiomyopathy in patients with blood cobalt levels as low as 13µg/l. Clinical studies have found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. The extent of cardiovascular injury, measured by global longitudinal strain (GLS), in patients with elevated blood cobalt levels has not previously been examined. Sixteen patients with prospectively collected blood cobalt ion levels above 13µg/l were identified and matched with eight patients awaiting hip arthroplasty with no history of cobalt implants. Patients underwent echocardiogram assessment including GLS. Patients with MoM hip arthroplasties had a mean blood cobalt level of 29µg/l compared to 0.01µg/l in the control group. There was no difference or correlation in EF, left ventricular (LV) end systolic dimension, LV end diastolic dimension, fractional shortening, ventricular wall thickness or E/e’ ratio. However, GLS was significantly reduced in patients with MoM hip arthroplasties compared to those without (−15.2% v −18%, (MoM v control) p= 0.0125). Pearson correlation demonstrated that GLS is significantly correlated with blood cobalt level (r= 0.8742, p=0.0009). For the first time, this study has demonstrated reduced cardiac function in the presence of normal EF as assessed by GLS in patients with elevated cobalt above 13µg/l. As GLS is a more sensitive measure of systolic function than EF, routine echocardiogram assessment including GLS should be performed in all patients with MoM hip arthroplasties and elevated blood cobalt.
Previous scientific studies have highlighted how coupling is an important element affecting total hip arthroplasty's survival. This study aims to evaluate whether metal-on-metal (MOM) coupling could be a statistically significant risk factor. The data from the regional joint registry (Registro dell'Impiantologia Protesica Ortopedica, RIPO) was used for analysis. The data collection accuracy of this registry was 97.2% in 2017. We retrospective evaluate all MOM total hip arthroplasties (THAs) implanted in our department between January 01st 2000 and December 31st 2011. We used a control group composed by all other prosthesis implanted in our Department in the same time lapse. We registered 660 MOM THAs. Mean age of patients was 66.9 years. 603 patients have a >36mm head, while 78 a <36 mm one. Neck modularity was present in half of patients. 676 implants were cementless. We registered 69 revisions, especially due to aseptic mobilization (16 THAs), implant breakage (9 THAs) and periprosthetic fracture (6 THAs). The MOM THAs overall Kaplan-Meier survival rate was 87.2 at 15 years, and the difference between MOM THAs and other implants two curves is statistically significant (p<0.05). Male sex is a significant risk factors. Further evaluations are in progress to establish the presence of any additional risk factors. We think weight and/or BMI may be included in this category. Our study confirms the data currently present in the literature regarding a lower survival of metal-on-metal hip prostheses. The male sex is a statistically significant risk factor (p<0.05), while age, head size and modularity of the prosthetic neck are not statistically significant (p>0.05). Any new finds will be presented at the congress venue.
Elevated blood cobalt secondary to metal-on-metal (MoM) hip arthroplasties has been shown to be a risk factor for developing cardiovascular complications including cardiomyopathy. Published case reports document cardiomyopathy in patients with blood cobalt levels as low as 13µg/l (13ppb, 221nmol/l). Clinical studies have found conflicting evidence of cobalt-induced cardiomyopathy in patients with MoM hips. Global longitudinal strain (GLS) is an echocardiography measurement known to be more sensitive than ejection fraction at diagnosing early cardiomyopathies. The extent of cardiovascular injury, as measured by GLS, in patients with elevated blood cobalt levels has not previously been examined. Sixteen patients with documented blood cobalt ion levels above 13µg/l were identified from a regional arthroplasty database. They were matched with eight patients awaiting hip arthroplasty with no history of cobalt implants. All patients underwent electrocardiogram and echocardiogram assessment for signs of cardiomyopathy including GLS. Patients with MoM hip arthroplasties had a mean blood cobalt level of 29µg/l (495nmol/l) compared to 0.01µg/l (0.2nmol/l) in the control group. There was no difference or correlation in ejection fraction (EF), left ventricular (LV) end systolic dimension, LV end diastolic dimension, fractional shortening, ventricular wall thickness or E/e’ ratio. However, GLS was significantly reduced in patients with MoM hip arthroplasties compared to those without (−15.2% v −18%, (MoM v control) p= 0.0125). Pearson correlation demonstrated that GLS is significantly correlated with blood cobalt level (r= 0.8742, p=0.0009). For the first time, this study has demonstrated reduced cardiac function in the presence of normal EF as assessed by GLS in patients with elevated cobalt above 13µg/l. As GLS is a more sensitive measure of systolic function than EF, routine echocardiogram assessment including GLS should be performed in all patients with MoM hip arthroplasties and elevated blood cobalt above 13µg/l. Further work is recommended to assess if these cardiac changes are present in patients with elevated blood cobalt levels below 13µg/l.
Introduction. We investigated whether blood metal ions could effectively identify bilateral
Introduction: Hip simulator and clinical retrieval studies have shown that
Metal-on-metal resurfacing of the hip (MoMHR)
has enjoyed a resurgence in the last decade, but is now again in question
as a routine option for osteoarthritis of the hip. Proponents of
hip resurfacing suggest that its survival is superior to that of
conventional hip replacement (THR), and that hip resurfacing is
less invasive, is easier to revise than THR, and provides superior
functional outcomes. Our argument serves to illustrate that none
of these proposed advantages have been realised and new and unanticipated
serious complications, such as pseudotumors, have been associated
with the procedure. As such, we feel that the routine use of MoMHR
is not justified. Cite this article:
Purpose.
The 22 year survivorship of metal on metal hip resurfacing arthroplasty (RSA) is reported to be 94.3% with expert surgeons, in males with head sizes greater than 48mm. The 2023 National Joint Registry (NJR) report estimates survivorship of all RSA at 19 years to be 85%. This estimate includes all designs, head sizes and females. Our aim was to estimate the survivorship of RSA currently available for implantation (males only, head size >48mm, MatOrtho Adept or Smith and Nephew Birmingham Hip Resurfacing (BHR)) in those under 55 years, performed by all surgeons, compared to conventional THR. We performed a retrospective analysis of the NJR. We included all males under 55 years who had undergone BHR or Adept RSA with head size greater than 48mm. Propensity score matching was used to produce two comparable groups of patients for RSA or conventional THR. We matched in a 3:1 ratio (THR:RSA) using sex, ASA, BMI group, age at primary procedure, surgeon volume, diagnosis and surgeon grade as covariates. The primary analysis was survivorship at 18 years. Time-to-revision was assessed using Kaplan-Meier curves. Cox's proportional hazard models were used to investigate between group differences. 4839 RSA were available for analysis. After matching the RSA and THR groups were well balanced in terms of covariates. Survivorship at 18 years was 93.7% (95% CI 89.9,96.2) in the RSA group and 93.9% (90.5,96.0) in the THR group. Despite these similar estimates the adjusted hazard ratio was 1.40 (95% CI 1.18, 1.67 p<0.001) in favour of THR. Survivorship of the currently available RSA in males under 55 was 93.7% at 18 years, however THR survivorship was superior to RSA. These results, generalisable to UK practice, should be set against perceived benefits in functional status offered in RSA when counselling patients.
The Conserve® Plus (Wright Medical Technology Inc., Arlington, TN) was introduced clinically in the United States in 1996. A study of the serum cobalt and chromium ion levels was started in 2000 in our center to monitor the metal ion levels over time as part of an FDA clinical trial. Thirteen male and five female patients received this resurfacing for idiopathic osteoarthritis (14), post-traumatic degenerative changes (3) or developmental dysplasia (1). Fourteen received a unilateral implant but four subsequently received a contralateral device from 52 to 86 months post-op. Four patients had bilateral resurfacings done in a one-stage procedure. All surgeries were performed by the senior author. None of these patients had known exposure to cobalt or chromium, kidney disease or other metal implants elsewhere in their bodies. Each prospectively provided blood samples and then yearly thereafter to measure cobalt and chromium levels for up to 11 years. Metal levels were measured using atomic absorption spectrophotometry and inductively coupled plasma mass spectrometry by a specialized trace element analysis laboratory. Acetabular component position was evaluated using Einzel-Bild-Röentgen-Analysis (EBRA) software. Contact patch to rim (CPR) distance was computed as described by Langton et al JBJS Br 91: 2009. A mixed model linear regression analysis was performed to evaluate long term trends, and multivariate analysis was performed to examine effects of implant and patient covariates on the metal ion levels. One bilateral patient underwent revision for femoral loosening, all other patients were clinically well-functioning at the time of last follow-up (ave 89 mos). The median pre-operative Co was below the detection limit (d.l) of 0.3μg/L and the median pre-operative Cr was 0.069μg/L (d.l. 03μg/L). Metal levels increased within the first year then decreased and stabilized (fig 1). For unilaterals over all time intervals, the median Co was 1.06 μg/L, while the median Cr was 1.58 μg/L. For bilaterals, the mean post-operative Co was 2.80 μg/L, while the mean Cr was 5.80 μg/L. Generally, Cr levels were higher at all time points than Co. Bilateral patients had Co values 1.96 times greater on average than the unilateral patients (p<0.001). None of the possible covariates studied (femoral size, cup abduction angle, cup anteversion, CPR distance, activity, BMI and testing method) were related to the assay values. The results of this study have shown that serum metal levels in well functioning implants can be low and do not increase over time. These are among the lowest levels reported for resurfacing devices and comparable to levels reported for well functioning small diameter
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
Local and systemic concentrations of cobalt (Co) and chromium (Cr) ions may be elevated in patients with accelerated tribo-corrosion at prosthesis bearing surfaces and modular taper junctions. Previous studies by us and others have shown that exposure to these metals negatively affect the viability and function of osteoblasts and osteoclasts in vitro, with implications for bone health. More recently, we have observed an increase in total bone mineral density and reduced bone turnover (TRAP5b and osteocalcin) in patients with well-functioning metal-on-metal hip resurfacing (MOMHR). Here, we provide data to support the hypothesis that osteoclast differentiation and function is altered in this patient population, and that this effect is transferrable through their serum. Patients with well-functioning MOMHR (n=18) at median follow-up of 8 years were individually matched for gender, age and time-since-surgery to a low-exposure group consisting of patients with metal-on-polyethylene total hip arthroplasty (THA). The median circulating concentrations of Co and Cr for the MOMHR group were 2.53µg/L and 2.5µg/L respectively, compared to 0.02µg/L and 0.03µg/L for the THA group. Monocyte fraction of peripheral blood was isolated from these patients, seeded onto dentine wafers and differentiated into osteoclasts using media supplemented with RANKL and M-CSF (osteoclastogenic media, OM). Cultures were monitored for the onset of resorption, following which they were treated with OM, autologous serum or serum from the other individual within the matched MOMHR - THA pair, all supplemented with RANKL and M-CSF. At the end of the culture, cells were TRAP stained and quantified for total osteoclast number, number of resorbing osteoclasts and percentage resorption using the CellD Software Package (Olympus, Southend-on-Sea, U.K.). For cells differentiated in osteoclastogenic media, the resorbing ability of osteoclasts derived from MOMHR patients was reduced by 30% (P=0.046) compared to THA. Correlation analyses showed that chronic exposure to Co and Cr trends towards negative association with resorption ability of these osteoclasts (r = −0.3, P=0.06). Furthermore, the resorbing ability of osteoclasts generated from MOMHR patients and differentiated in autologous serum was reduced 33% (p < 0 .0001), whilst matched THA serum caused a smaller reduction of 14% (p < 0 .01). When cells derived from THA patients were differentiated in autologous serum, the resorbing ability of osteoclasts was similarly reduced by 35% (p < 0 .0001), whilst the matched MOMHR serum also caused a reduction of 21% (p < 0 .0001). Reduced osteoclastogenic response of precursor cells from patients with higher circulating Co and Cr suggests an inherent change in their potential to differentiate into functional osteoclasts. The data also suggests that functional response of mature osteoclasts generated from patient precursor cells are dependent on the prior systemic metal concentrations and the presence of higher circulating CoCr in patients with MOMHR. These effects are modest, but may explain the subtle increase in systemic bone mineral density and decreased bone turnover observed in patients after 8 years exposure compared to age, sex, and exposure-time matched patients who received a conventional THA.
Metal on metal hip replacements have been one of worst failures in recent years in terms of orthopaedic implants. Some of these devices have had catastrophic failure rates, with reports of 48% failure at 6 years. The failure of these devices has led to considerable suffering, pain and reduction in quality of life; consequently, they have given rise to high costs and multi-million-dollar legal cases. This talk will describe the history of the current metal on metal failure and discuss some of the reasons why might have occurred. It will also consider the reasons that wear debris arising from the trunnion is worse in terms of biological activity then that arising from the bearing surfaces.
The articulating surface replacement (ASR) XL stemmed total hip replacement and ASR resurfacing hip systems were recalled by DePuy due to a high prevalence of early failure. The ASR XL has a greater failure rate than the ASR resurfacing, which has been increasingly attributed to wear and corrosion at the taper interface between the female taper surface of the femoral head and the male taper (trunnion) of the femoral stem. The aim of this study was to quantify the prevalence and severity of taper corrosion in retrieved ASR XL hip components. A peer-reviewed subjective corrosion scoring system was used to quantify corrosion in a consecutive series of the 50 ASR XL hip components (head components – n=44; femoral stems – n=6) at our retrieval centre. Bearing surface wear (femoral head and acetabular cup combined) was quantified and a value of <5 microns was defined as low-wearing. Subsequent profilometry analysis was undertaken in the low-wearing hips to quantify material loss from the taper interface. 90% of components showed evidence of corrosion, with at least moderate corrosion observed in 58%. There were 17 low-wearing hips which had a median material loss from the taper interface of 3.51mm. 3. (range: 0.612–9.443). The median linear depth of material loss was 33μm (range: 8.5–78.0). No relationship was observed between taper corrosion and serum cobalt (r=0.204, p=0.2712) or chromium (r=0.146, p=0.432) metal ions. Wear and material loss from
Introduction and Aims: