Objectives. 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. Methods. 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. Results. Our literature search returned 575 unique articles; only six met inclusion criteria defined a priori. The discriminative capacity of ion tests was homogeneous across studies but that there was substantial cut-point heterogeneity. Our best estimate of the “true” area under curve (AUC) for metal ion testing is 0.615, with a 95% credible interval of 0.480 to 0.735, thus we can state that the probability that metal ion testing is actually clinically useful with an AUC ≥ 0.75 is 1.7%. Conclusion. Metal ion levels are not useful as a screening test for identifying high risk patients because ion testing will either lead to a large burden of false positive patients, or otherwise marginally modify the pre-test probability. With the availability of more accurate non-invasive tests, we did not find any evidence for using blood ion levels to diagnose symptomatic patients. Cite this article: M. Pahuta, J. M. Smolders, J. L. van Susante, J. Peck, P. R. Kim, P. E. Beaule.
Aims. We investigated whether
Objectives. 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. Methods. 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 in vitro study during which human blood was
spiked with trivalent and hexavalent Cr, the serum then separated
and the fractions analysed. Results. Only one patient in the transfusion group was found to have a
blood Co >
2 µg/l. Blood/Serum Cr and Co concentrations were reliable
indicators of abnormal wear. Blood Co appeared to be the most useful
clinical test, with a concentration of 4.5 µg/l showing sensitivity
and specificity for the detection of abnormal wear of 94% and 95%, respectively.
Generated metal ions tended to fill the serum compartment preferentially in
vivo and this was replicated in the in vitro study
when blood was spiked with trivalent Cr and bivalent Co. Conclusions.
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.
The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions.Aims
Methods
Aims. To determine whether there is any association between glomerular
filtration rate (GFR) and blood cobalt (Co) and chromium (Cr) levels
in patients with metal-on-metal (MoM) hip arthroplasty. Patients and Methods. We identified 179 patients with a unilateral 36 mm diameter head
as part of a stemmed Summit-Pinnacle MoM hip arthroplasty. GFR was
calculated using the Modification of Diet in Renal Disease formula. Results. Normal renal function (GFR ≥ 90 ml/min/1.73 m. 2. ) was
seen in 74 patients. Mild renal insufficiency (GFR 60 to 89 ml/min/1.73
m. 2. ) was seen in 90 patients and moderate renal insufficiency
(GFR 30 to 59 ml/min/1.73 m. 2. ) in 15. There was no statistical
difference in Co and Cr levels between patients with normal renal
function and those with mild or moderate renal insufficiency. No
correlation was seen between creatinine and
Aims. The purpose of this study was to compare two different types
of metal-on-metal (MoM) bearing for total hip arthroplasty (THA):
one with a large femoral head (38 mm to 52 mm) and the other with
a conventional femoral head (28 mm or 32 mm). We compared clinical
outcome,
This study compared component wear rates and pre-revision
Aims. To find out if there is an inverse association between estimated glomerular filtration rate (eGFR) and whole blood cobalt (Co) and chromium (Cr) levels in patients with metal-on-metal (MoM) hip arthroplasties and renal insufficiency, suggesting that renal insufficiency could cause accumulation of Co and Cr in blood. Methods. Out of 2,520 patients with 3,013 MoM hip arthroplasties, we identified 1,244 patients with whole blood Co, Cr, and creatinine measured within no more than a one-year interval. We analyzed the correlation of
Aims. Dual mobility (DM) implants have been shown to reduce the dislocation rate after total hip arthroplasty (THA), but there remain concerns about the use of cobalt chrome liners inserted into titanium shells. The aim of this study was to assess the clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) at mid-term follow-up in young, active patients receiving a modular DM THA. Methods. This was a prospective study involving patients aged < 65 years, with a BMI of < 35 kg/m. 2. , and University of California, Los Angeles activity score of > 6 who underwent primary THA with a modular cobalt chrome acetabular liner, highly cross-linked polyethylene mobile bearing, and a cementless titanium femoral stem. Patient-reported outcome measures, whole
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
Aims. The aim of this study was to evaluate
Aims. To analyze the short-term outcome of two types of total wrist arthroplasty (TWA) in terms of wrist function, migration, and periprosthetic bone behaviour. Methods. A total of 40 patients suffering from non-rheumatoid wrist arthritis were enrolled in a randomized controlled trial comparing the ReMotion and Motec TWAs. Patient-rated and functional outcomes, radiological changes,
Aims. Modular dual mobility (DM) prostheses in which a cobalt-chromium liner is inserted into a titanium acetabular shell (vs a monoblock acetabular component) have the advantage of allowing supplementary screw fixation, but the potential for corrosion between the liner and acetabulum has raised concerns. While DM prostheses have shown improved stability in patients deemed ‘high-risk’ for dislocation undergoing total hip arthroplasty (THA), their performance in young, active patients has not been reported. This study’s purpose was to assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular DM acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design. Patients and Methods. This was a prospective study of patients between 18 and 65 years of age, with a body mass index (BMI) < 35 kg/m. 2. and University of California at Los Angeles (UCLA) activity score > 6, who received a modular cobalt-chromium acetabular liner, highly crosslinked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. A total of 43 patients (30 male, 13 female; mean age 52.6 years (. sd. 6.5)) were enrolled. All patients had a minimum of two years’ clinical follow-up. Patient-reported outcome measures, whole
The Articular Surface Replacement (ASR) hip resurfacing arthroplasty has a failure rate of 12.0% at five years, compared with 4.3% for the Birmingham Hip Resurfacing (BHR). We analysed 66 ASR and 64 BHR explanted metal-on-metal hip replacements with the aim of understanding their mechanisms of failure. We measured the linear wear rates of the acetabular and femoral components and analysed the clinical cause of failure, pre-revision
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 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. Methods. 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
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
This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole
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 ASR/SROM (n = 13).