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The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 44 - 50
1 Mar 2024
Engh, Jr CA Bhal V Hopper, Jr RH

Aims. The first aim of this study was to evaluate whether preoperative renal function is associated with postoperative changes in whole blood levels of metal ions in patients who have undergone a Birmingham Hip Resurfacing (BHR) arthroplasty with a metal-on-metal bearing. The second aim was to evaluate whether exposure to increased cobalt (Co) and chromium (Cr) levels for ten years adversely affected renal function. Methods. As part of a multicentre, prospective post-approval study, whole blood samples were sent to a single specialized laboratory to determine Co and Cr levels, and the estimated glomerular filtration rate (eGFR). The study included patients with 117 unrevised unilateral BHRs. There were 36 females (31%). The mean age of the patients at the time of surgery of 51.3 years (SD 6.5), and they all had preoperative one-, four-, five-, and ten-year laboratory data. The mean follow-up was 10.1 years (SD 0.2). Results. Median Co levels at one year postoperatively increased significantly compared with the preoperative values, by a factor of 9.7, from 0.13 to 1.26 ppb (p < 0.001), and the median Cr levels increased significantly by a factor of 2.5, from 0.60 to 1.50 ppb (p < 0.001). Lower preoperative eGFRs were associated with significantly larger increases in Co at one year compared with the preoperative levels (ρ = -0.26; p = 0.005), but there was no relationship between preoperative eGFRs and changes in Cr at one year (ρ = -0.13; p = 0.153). Metal levels remained relatively constant with the passage of time, with a median ten-year value of 1.12 ppb for Co and 1.29 ppb for Cr. There was no significant relationship between the Co and Cr levels at ten-year follow-up and the change in eGFR from the preoperative level to that at ten years (ρ = -0.02; p = 0.827 for Co; ρ = -0.008; p = 0.933 for Cr). Conclusion. Although patients with lower preoperative eGFRs tended to have larger increases in Co levels at one year, increased metal levels for patients who underwent unilateral BHR did not adversely affect renal function during the first ten postoperative years. Cite this article: Bone Joint J 2024;106-B(3 Supple A):44–50


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 775 - 782
1 Jul 2023
Koper MC Spek RWA Reijman M van Es EM Baart SJ Verhaar JAN Bos PK

Aims. The aims of this study were to determine if an increasing serum cobalt (Co) and/or chromium (Cr) concentration is correlated with a decreasing Harris Hip Score (HHS) and Hip disability and Osteoarthritis Outcome Score (HOOS) in patients who received the Articular Surface Replacement (ASR) hip resurfacing arthroplasty (HRA), and to evaluate the ten-year revision rate and show if sex, inclination angle, and Co level influenced the revision rate. Methods. A total of 62 patients with an ASR-HRA were included and monitored yearly postoperatively. At follow-up, serum Co and Cr levels were measured and the HHS and the HOOS were scored. In addition, preoperative patient and implant variables and the need for revision surgery were recorded. We used a linear mixed model to relate the serum Co and Cr levels to different patient-reported outcome measures (PROMs). For the survival analyses we used the Kaplan-Meier and Cox regression model. Results. We found that an increase of one part per billion (ppb) in serum Co and Cr levels correlated significantly with worsening of the HHS in the following year. This significant correlation was also true for the HOOS-Pain and HOOS-quality of life sub scores. The overall ten-year survival rate in our cohort was 65% (95% confidence interval (CI) 52.5 to 77.6). Cox regression analysis showed a significant hazard ratio (HR) of 1.08 (95% CI 1.01 to 1.15; p = 0.028) for serum Co level. No significance was found with sex or inclination angle. Conclusion. This study shows that increasing serum Co and Cr levels measured in patients with an ASR-HRA are predictive for deterioration in HHS and HOOS subscales in the following year. Increasing serum Co and Cr should forewarn both surgeon and patient that there is a heightened risk of failure. Continued and regular review of patients with an ASR-HRA implant by measurement of serum Co/Cr levels and PROMs remains essential. Cite this article: Bone Joint J 2023;105-B(7):775–782


The Bone & Joint Journal
Vol. 104-B, Issue 10 | Pages 1132 - 1141
1 Oct 2022
Holm-Glad T Røkkum M Röhrl SM Roness S Godang K Reigstad O

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, blood metal ion levels, migration measured by model-based radiostereometric analysis (RSA), bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA), complications, loosening, and revision rates at two years were compared. Results. Patient-Rated Wrist and Hand Evaluation (PRWHE) scores, abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH) scores, and pain improved similarly and significantly in both groups. Wrist motion improved significantly in the Motec group only, and forearm rotation in the ReMotion group only. Cobalt (Co) and chromium (Cr) blood ion levels were significantly higher in the metal-on-metal (MoM) Motec group than in the metal-on-polyethylene (MoP) ReMotion group. Mean total translation was 0.65 mm (95% confidence interval (CI) 0.26 to 1.12) and 0.27 mm (95% CI 0.14 to 0.47) for the ReMotion carpal and radial components, and 0.32 mm (95% CI 0.22 to 0.45) and 0.26 mm (95% CI 0.20 to 0.34) for the Motec metacarpal and radial components, respectively. Apart from dorsal and volar tilts, which were significantly higher for the radial ReMotion than for the Motec component, no significant differences in absolute migration occurred. BMD around the radial components never returned to baseline. Almost one-third of patients required reoperation due to complications. Two ReMotion implants were revised to Motec TWAs due to carpal component loosening, and three Motec MoM articulations were revised to metal-on-polyether ether ketone due to painful synovitis. Conclusion. Both implants provided matched function and were stable at short-term follow-up, but with a high complication rate. This procedure should be restricted to specialist centres undertaking prospective analysis until its role is clarified. Cite this article: Bone Joint J 2022;104-B(10):1132–1141


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1231 - 1237
1 Jul 2021
Manninen E Lainiala O Karsikas M Reito A Jämsä P Eskelinen A

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 blood metal ion levels and eGFR to identify a potential trend of accumulating Co or Cr with decreasing eGFR. Results. Of the 1,244 patients, 112 had normal renal function (eGFR > 90 ml/min/1.73 m. 2. ), 715 had mild renal insufficiency (eGFR 60 to 89), 384 had moderate renal insufficiency (eGFR 30 to 59), 27 had severe renal insufficiency (eGFR 15 to 29), and six had end-stage renal insufficiency (eGFR < 15). Median eGFR was 68 ml/min/1.73 m. 2. (interquartile range (IQR) 56 to 82), median whole blood Co was 3.3 µg/l (IQR 1.1 to 9.9), and median Cr was 2.0 µg/l (IQR 1.2 to 3.6). We did not observe an association between decreased eGFR and increased whole blood Co and Cr concentrations, but instead both increased Co and Cr were associated with higher eGFR, indicating better kidney function. Conclusion. As patients with MoM hip arthroplasties get older, the prevalence of renal insufficiency among them will increase, and orthopaedic surgeons will increasingly have to evaluate whether or not this affects patient follow-up. The USA Food and Drug Administration suggests that closer follow-up may be needed for MoM patients with renal insufficiency. We did not observe accumulation of blood Co or Cr in MoM hip arthroplasty patients with mild to severe renal insufficiency. Cite this article: Bone Joint J 2021;103-B(7):1231–1237


Bone & Joint Research
Vol. 7, Issue 6 | Pages 388 - 396
1 Jun 2018
Langton DJ Sidaginamale RP Joyce TJ Bowsher JG Holland JP Deehan D Nargol AVF Natu S

Objectives. 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). Patients and Methods. 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. Results. In the resurfacing cohort (n = 76), the statistical modelling indicated that the presence of severe ALVAL and a large fluid collection were associated with greater joint fluid Co concentrations after adjustment for volumetric wear rates (p = 0.005). These findings were replicated in the mixed implant group (n = 178), where the presence of severe ALVAL and a large fluid collection were significantly associated with greater fluid Co concentrations (p < 0.001). Conclusion. The development of severe ALVAL is associated with elevations in metal ion concentrations far beyond those expected from the volumetric loss from the prosthetic surfaces. This finding may aid the understanding of the sequence of events leading to soft-tissue reactions following MoM hip arthroplasties. Cite this article: D. J. Langton, R. P. Sidaginamale, T. J. Joyce, J. G. Bowsher, J. P. Holland, D. Deehan, A. V. F. Nargol, S. Natu. Aseptic lymphocyte-dominated vasculitis-associated lesions are related to changes in metal ion handling in the joint capsules of metal-on-metal hip arthroplasties. Bone Joint Res 2018;7:388–396. DOI: 10.1302/2046-3758.76.BJR-2018-0037


The Bone & Joint Journal
Vol. 101-B, Issue 9 | Pages 1035 - 1041
1 Sep 2019
Markel DC Bou-Akl T Rossi MD Pizzimenti N Wu B Ren W

Aims. The aim of this study was to evaluate blood metal ion levels, leucocyte profiles, and serum cytokines in patients with a total hip arthroplasty (THA) involving modular dual-mobility components. Patients and Methods. A total of 39 patients were recruited, with clinical follow-up of up to two years. Outcome was assessed using the Harris Hip Score (HHS, the 12-Item Short-Form Health Survey (SF-12), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a visual analogue scale (VAS) for pain. Blood concentrations of cobalt (Co), chromium (Cr), and serum cytokines were measured. Subpopulations of leucocytes were analyzed by flow cytometry. Results. The clinical performance was good. Blood Co levels (ref 1.0 µg/l) were mildly elevated in seven patients at three months, and two patients at two years’ follow-up. The preoperative Cr levels were normal except for one patient with a detectable Cr (1.2 µg/l). Cr levels were detectable in three patients at three months, two patients at one year, and three patients at two years’ follow-up. No patients had symptoms suggestive of failure. Although flow cytometry showed constant circulating leucocyte profiles, there was a significant reduction of serum interleukin (IL)-4, IL-5, and interferon gamma (IFNγ) postoperatively compared with the preoperative levels (p < 0.05). Conclusion. These results suggest that THA using modular dual-mobility components is safe. This allows an opportunity to use a large femoral head and a thick polyethylene bearing surface, which is especially useful in revision procedures or high-risk situations when added stability is required. Cite this article: Bone Joint J 2019;101-B:1035–1041


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 12 - 12
12 Dec 2024
Langton D Bhalekar R Wells S Nargol M Natu S Nargol A Waller S Pabbruwe M Sidaginamale R
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Objectives. Several studies have reported elevated blood cobalt (Co) and chromium (Cr) concentrations in patients with total knee replacements (TKRs). Up to 44% of tissue samples taken from patients with failed TKRs exhibit histological evidence of metal sensitivity/ALVAL. In simulated conditions, metal particles contribute approximately 12% of total wear debris in TKR. We carried out this investigation to determine the source and quantity of metal release in TKRs. Design and Methods. We analysed 225 explanted fixed-bearing TKRs (Attune, Genesis II, NexGen, PFC, and Vanguard) revised for any indication. These were analysed using peer-reviewed [coordinate measuring machine (CMM)] methodology to measure the volumetric wear of the polyethylene (PE) bearing surfaces and trays. The trays were analysed using 2D profilometry (surface roughness-Ra) and light microscopy. Histological and blood metal ion concentration analyses were performed in a sub-sample of patients. Results. The median (IQR) PE wear rate was 14 (6 to 20) mm. 3. /year. Microscopic examination of the superior surface of trays exhibited pitting on 132 (59%) of trays. There was a statistically significant (p<0.05) increase in Rvk on the pitted area of trays for each design, indicating material removal from the pits compared to the unpitted area. The inferior surface of 116(51%) of trays displayed polishing, indicative of abrasive wear. The median(range) Co and Cr concentrations were 2.5µg/l (0.2–69.4) and 1.7µg/l (0.5-12.5) respectively in 40 patients. Of the tissue samples examined in 30 patients, 6 had at least “mild”-ALVAL infiltrate. All corresponding “ALVAL” explants were found to be pitted and/or show evidence of loosening of the tray. Conclusion. This study provides further evidence that CoCr release in TKR appears to be an under-appreciated cause of adverse clinical outcomes. The generation of metal particles was predominantly from the metal tray, which may explain elevated metal ions after TKRs, despite no direct metal-on-metal contact


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 33 - 33
23 Jun 2023
Engh CA Bhal V Hopper RH
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When the Birmingham Hip Resurfacing (BHR) metal-on-metal implant system was approved by the United States Food and Drug Administration in 2006, a multicenter, prospective, post-approval study (PAS) was required. This study uses data from the PAS to investigate metal level and glomerular filtration rate (GFR) trends over the first decade in vivo. Between October 2006 and March 2011, 290 primary BHR procedures were performed among 262 patients at 5 sites. Whole blood samples were sent to a single specialized laboratory to determine GFR, cobalt (Co) and chromium (Cr) levels. The population for this study consists of 117 unrevised unilateral patients with a mean age at surgery of 51.3±6.5 years who had pre-operative, 1-year, 4-year, 5-year and 10-year laboratory data. The mean follow-up for these patients that included 36 females was 10.1±0.2 years. Median metal levels at 1-year increased relative to pre-operative values for Co (by a factor of 9.7 from 0.13 to 1.26 ppb, p<0.001) and Cr (by a factor of 2.5 from 0. 60 to 1.50 ppb, p<0.001). Metal levels subsequently remained relatively constant over time with a median 10-year value of 1.12 ppb for Co and 1.29 ppb for Cr. Based on 585 blood samples from all 117 patients, there was no relationship between GFR and Co (. →. =−0.06, p=0.14) or Cr (. →. =0.05, p=0.27) levels. However, lower pre-operative GFR values were associated with larger increases in Co at 1-year relative to the pre-operative level (. →. =−0.26, p=0.005). There was no relationship between pre-operative GFR values and changes in Cr at 1 year (. →. =−0.13, p=0.15). Through the first decade in vivo, elevated whole blood metal levels for unilateral BHR patients do not appear to adversely affect GFR. However, patients with lower pre-operative GFR values tend to have larger increases in their Co level at 1-year


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 22 - 22
1 Dec 2022
Werle J Kearns S Bourget-Murray J Johnston K
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A concern of metal on metal hip resurfacing arthroplasty is long term exposure to Cobalt (Co) and Chromium (CR) wear debris from the bearing. This study compares whole blood metal ion levels from patients drawn at one-year following Birmingham Hip Resurfacing (BHR) to levels taken at a minimum 10-year follow-up. A retrospective chart review was conducted to identify all patients who underwent a BHR for osteoarthritis with a minimum 10-year follow-up. Whole blood metal ion levels were drawn at final follow-up in June 2019. These results were compared to values from patients with one-year metal ion levels. Of the 211 patients who received a BHR, 71 patients (54 males and 17 females) had long term metal ion levels assessed (mean follow-up 12.7 +/− 1.4 years). The mean Co and Cr levels for patients with unilateral BHRs (43 males and 13 females) were 3.12 ± 6.31 ug/L and 2.62 ± 2.69 ug/L, respectively, and 2.78 ± 1.02 ug/L and 1.83 ± 0.65 ug/L for patients with bilateral BHRs (11 males and 4 females). Thirty-five patients (27 male and 8 female) had metal-ion levels tested at one-year postoperatively. The mean changes in Co and Cr levels were 2.29 ug/l (p = 0.0919) and 0.57 (p = 0.1612), respectively, at one year compared to long-term. These changes were not statistically significant. This study reveals that whole blood metal ion levels do not change significantly when comparing one-year and ten-year Co and Cr levels. These ion levels appear to reach a steady state at one year. Our results also suggest that regular metal-ion testing as per current Medicines and Healthcare products Regulatory Agency (MHRA) guidelines may be impractical for asymptomatic patients. Metal-ion levels, in and of themselves, may in fact possess little utility in determining the risk of failure and should be paired with radiographic and clinical findings to determine the need for revision


The Bone & Joint Journal
Vol. 99-B, Issue 9 | Pages 1147 - 1152
1 Sep 2017
Lainiala O Reito A Jämsä P Eskelinen A

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 blood metal ion levels or between GFR and blood metal ion levels. Linear regression analysis did not show any association between Co and Cr levels and GFR. Conclusion. We did not find any association between GFR and blood metal ion levels. Consequently, the accumulation of Co and Cr in blood due to renal insufficiency does not seem to be a major risk in patients with mild or moderate renal insufficiency. Cite this article Bone Joint J 2017;99-B:1147–52


The Bone & Joint Journal
Vol. 99-B, Issue 4_Supple_B | Pages 33 - 40
1 Apr 2017
Galea VP Laaksonen I Matuszak SJ Connelly JW Muratoglu O Malchau H

Aims. Our first aim was to determine whether there are significant changes in the level of metal ions in the blood at mid-term follow-up, in patients with an Articular Surface Replacement (ASR) arthroplasty. Secondly, we sought to identify risk factors for any increases. Patients and Methods. The study involved 435 patients who underwent unilateral, metal-on-metal (MoM) hip resurfacing (HRA) or total hip arthroplasty (THA). These patients all had one measurement of the level of metal ions in the blood before seven years had passed post-operatively (early evaluation) and one after seven years had passed post-operatively (mid-term evaluation). Changes in ion levels were tested using a Wilcoxon signed-rank test. We identified subgroups at the highest risk of increase using a multivariable linear logistic regression model. Results. There were significant increases in the levels of metal ions for patients who underwent both MoM HRA (Chromium (Cr): 0.5 parts per billion (ppb); Cobalt (Co): 1.1 ppb) and MoM THA (Cr: 0.5 ppb; Co: 0.7 ppb). In a multivariable model considering MoM HRAs, the change in the levels of metal ions was influenced by female gender (Co: Odds Ratio (OR) 1.42; p = 0.002 and Cr: OR 1.08; p = 0.006). The change was found to be irrespective of the initial level for the MoM HRAs, whereas there was a negative relationship between the initial level and the change in the level for those with a MoM THA (Co: OR -0.43; p <  0.001 and Cr: OR -0.14; p = 0.033). Conclusion. The levels of metal ions in the blood increase significantly over the period until mid-term follow-up in patients with both a MoM HRA and those with a MoM THA. We recommend that the levels of metal ions be measured most frequently for women with a MoM HRA. While those with a MoM THA appear to stabilise at a certain level, the accuracy of this trend is not yet clear. Vigilant follow-up is still recommended. . Cite this article: Bone Joint J 2017;99-B(4 Supple B):33–40


Bone & Joint Research
Vol. 2, Issue 5 | Pages 84 - 95
1 May 2013
Sidaginamale RP Joyce TJ Lord JK Jefferson R Blain PG Nargol AVF Langton DJ

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. Blood/serum metal ion concentrations are reliable indicators of abnormal wear processes. Important differences exist however between elements and the blood fraction under study. Future guidelines must take these differences into account


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 925 - 933
1 Jul 2016
Sidaginamale RP Joyce TJ Bowsher JG Lord JK Avery PJ Natu S Nargol AVF Langton DJ

Aims. 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. . Patients and Methods. 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. . Results. The statistical modelling suggested that a greater source contribution of metal debris from the taper junction was associated with smaller aggregated particle sizes in the local tissues and a relative reduction of Cr ion concentrations in the corresponding synovial fluid and blood samples. Metal debris generated from taper junctions appears to be of a different morphology, composition and therefore, potentially, immunogenicity to that generated from bearing surfaces. Conclusion. The differences in debris arising from the taper and the articulating surfaces may provide some understanding of the increased incidence of soft-tissue reactions reported in patients implanted with MoM total hip arthroplasties compared with patients with hip resurfacings. Cite this article: Bone Joint J 2016;98-B:925–33


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 12 - 19
1 Jan 2010
Vendittoli P Roy A Mottard S Girard J Lusignan D Lavigne M

We have updated our previous randomised controlled trial comparing release of chromium (Cr) and cobalt (Co) ions and included levels of titanium (Ti) ions. We have compared the findings from 28 mm metal-on-metal total hip replacement, performed using titanium CLS/Spotorno femoral components and titanium AlloFit acetabular components with Metasul bearings, with Durom hip resurfacing using a Metasul articulation or bearing and a titanium plasma-sprayed coating for fixation of the acetabular component. Although significantly higher blood ion levels of Cr and Co were observed at three months in the resurfaced group than in total hip replacement, no significant difference was found at two years post-operatively for Cr, 1.58 μg/L and 1.62 μg/L respectively (p = 0.819) and for Co, 0.67 μg/L and 0.94 μg/L respectively (p = 0.207). A steady state was reached at one year in the resurfaced group and after three months in the total hip replacement group. Interestingly, Ti, which is not part of the bearing surfaces with its release resulting from metal corrosion, had significantly elevated ion levels after implantation in both groups. The hip resurfacing group had significantly higher Ti levels than the total hip replacement group for all periods of follow-up. At two years the mean blood levels of Ti ions were 1.87 μg/L in hip resurfacing and and 1.30 μg/L in total hip replacement (p = 0.001). The study confirms even with different bearing diameters and clearances, hip replacement and 28 mm metal-on-metal total hip replacement produced similar Cr and Co metal ion levels in this randomised controlled trial study design, but apart from wear on bearing surfaces, passive corrosion of exposed metallic surfaces is a factor which influences ion concentrations. Ti plasma spray coating the acetabular components for hip resurfacing produces significantly higher release of Ti than Ti grit-blasted surfaces in total hip replacement


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 5 | Pages 628 - 631
1 May 2005
Dunstan E Sanghrajka AP Tilley S Unwin P Blunn G Cannon SR Briggs TWR

Metal-on-metal hip bearings are being implanted into younger patients. The consequence of elevated levels of potentially carcinogenic metal ions is therefore a cause for concern. We have determined the levels of cobalt (Co), chromium (Cr), titanium (Ti) and vanadium (Va) in the urine and whole blood of patients who had had metal-on-metal and metal-on-polyethylene articulations in situ for more than 30 years. We compared these with each other and with the levels for a control group of subjects. We found significantly elevated levels of whole blood Ti, Va and urinary Cr in all arthroplasty groups. The whole blood and urine levels of Co were grossly elevated, by a factor of 50 and 300 times respectively in patients with loose metal-on-metal articulations when compared with the control group. Stable metal-on-metal articulations showed much lower levels. Elevated levels of whole blood or urinary Co may be useful in identifying metal-on-metal articulations which are loose


The Bone & Joint Journal
Vol. 95-B, Issue 10 | Pages 1332 - 1338
1 Oct 2013
Van Der Straeten C Van Quickenborne D De Roest B Calistri A Victor J De Smet K

A retrospective study was conducted to investigate the changes in metal ion levels in a consecutive series of Birmingham Hip Resurfacings (BHRs) at a minimum ten-year follow-up. We reviewed 250 BHRs implanted in 232 patients between 1998 and 2001. Implant survival, clinical outcome (Harris hip score), radiographs and serum chromium (Cr) and cobalt (Co) ion levels were assessed. Of 232 patients, 18 were dead (five bilateral BHRs), 15 lost to follow-up and ten had been revised. The remaining 202 BHRs in 190 patients (136 men and 54 women; mean age at surgery 50.5 years (17 to 76)) were evaluated at a minimum follow-up of ten years (mean 10.8 years (10 to 13.6)). The overall implant survival at 13.2 years was 92.4% (95% confidence interval 90.8 to 94.0). The mean Harris hip score was 97.7 (median 100; 65 to 100). Median and mean ion levels were low for unilateral resurfacings (Cr: median 1.3 µg/l, mean 1.95 µg/l (< 0.5 to 16.2); Co: median 1.0 µg/l, mean 1.62 µg/l (< 0.5 to 17.3)) and bilateral resurfacings (Cr: median 3.2 µg/l, mean 3.46 µg/l (< 0.5 to 10.0); Co: median 2.3 µg/l, mean 2.66 µg/l (< 0.5 to 9.5)). In 80 unilateral BHRs with sequential ion measurements, Cr and Co levels were found to decrease significantly (p < 0.001) from the initial assessment at a median of six years (4 to 8) to the last assessment at a median of 11 years (9 to 13), with a mean reduction of 1.24 µg/l for Cr and 0.88 µg/l for Co. Three female patients had a > 2.5 µg/l increase of Co ions, associated with head sizes ≤ 50 mm, clinical symptoms and osteolysis. Overall, there was no significant difference in change of ion levels between genders (Cr, p = 0.845; Co, p = 0.310) or component sizes (Cr, p = 0.505; Co, p = 0.370). Higher acetabular component inclination angles correlated with greater change in ion levels (Cr, p = 0.013; Co, p = 0.002). Patients with increased ion levels had lower Harris hip scores (p = 0.038). In conclusion, in well-functioning BHRs the metal ion levels decreased significantly at ten years. An increase > 2.5 µg/l was associated with poor function. Cite this article: Bone Joint J 2013;95-B:1332–8


The Bone & Joint Journal
Vol. 97-B, Issue 9 | Pages 1183 - 1191
1 Sep 2015
Briggs TWR Hanna SA Kayani B Tai S Pollock RC Cannon SR Blunn GW Carrington RWJ

The long term biological effects of wear products following total hip arthroplasty (THA) are unclear. However, the indications for THA are expanding, with increasingly younger patients undergoing the procedure. This prospective, randomised study compared two groups of patients undergoing THA after being randomised to receive one of two different bearing surfaces: metal-on-polyethylene (MoP) n = 22 and metal-on-metal (MoM) n = 23. We investigated the relationship between three variables: bearing surface (MoP vs MoM), whole blood levels of chromium (Cr) and cobalt (Co) and chromosomal aberrations in peripheral lymphocyte pre-operatively and at one, two and five years post-surgery. Our results demonstrated significantly higher mean cobalt and chromium (Co and Cr) blood levels in the MoM group at all follow-up points following surgery (p < 0.01), but there were no significant differences in the chromosomal aberration indices between MoM and MoP at two or five years (two years: p = 0.56, p = 0.08, p = 0.91, p = 0.51 and five years: p = 0.086, p = 0.73, p = 0.06, p = 0.34) for translocations, breaks, loss and gain of chromosomes respectively. Regression analysis showed a strong linear relationship between Cr levels and the total chromosomal aberration indices in the MoM group (R. 2.  = 0.90016), but this was not as strong for Co (R. 2. = 0.68991). In the MoP group, the analysis revealed a poor relationship between Cr levels and the total chromosomal aberration indices (R. 2. = 0.23908) but a slightly stronger relationship for Co (R. 2. = 0.64292). Across both groups, Spearman’s correlation detected no overall association between Co and Cr levels and each of the studied chromosomal aberrations. There remains no clear indication which THA bearing couple is the most biocompatible, especially in young active patients. While THA continues to be very successful at alleviating pain and restoring function, the long-term biological implications of the procedure still require further scrutiny. Cite this article: Bone Joint J 2015;97-B:1183–91


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_10 | Pages 20 - 20
1 Oct 2020
Engh CA Ho H Bhal V Housman LR Masonis JL Noble JW Hopper RH Su EP
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Introduction. The BIRMINGHAM HIP. ◊. Resurfacing is a metal-on-metal (MOM) hip implant system approved by the US FDA in 2006. The approval required a multicenter, prospective, post-approval study (PAS). Our purpose is to report the current minimum 10-year results. Methods. 253 patients (280 hips) had surgery between October 2006 and December 2009 at one of 5 sites. We report revisions, survivorship, EQ-5D, Harris Hip Score (HHS), radiographic findings, and metal levels including cobalt (Co) and chromium (Cr). The mean age at surgery was 51 years, 74% male, BMI 28, osteoarthritis 95%. 243 (87%) of hips have known outcome or 10-year minimum follow-up (fup). Prior to 10 years, 5 patients died, 20 hips were revised, and 37 hips did not complete 10-year fup. Results. The 10-year component survivorship is 92.9% (95% CI 89.8–96.1%). The reasons for revision were femoral neck fracture (3), femoral loosening (5), acetabular loosening (1), pseudotumor (3), osteolysis (2) and the remaining 6 for a combination of pain, noise, or metal levels. The EQ-QAL VAS improved (mean preop: 70, 1-year: 89, p<0.001) and was stable through 10 years (87, p=0.05). The HHS improved (mean preop: 57, 1-year: 96, p<0.001) and remained stable through 10 years (96, p=0.93). Radiographically, no surviving components have migrated. 4.6% (10/218) have osteolysis. The Co and Cr levels increased at 1 year (median Co preop: 0.12 ppb, 1-year: 1.5 ppb, p<0.001; Cr preop: 0.60 ppb, 1-year: 1.70 ppb, p<0.001) and remained stable through 10 years (Co 10-year: 1.29 ppb, p=0.28; Cr 10-year: 1.36 ppb, p=0.88). The number of patients with a Co or Cr >7 ppb at one and 10 years remained similar (1-year: 3.4% (7/205), 10-year: 4.4%, (9/205), p=0.61). Conclusion. This prospective, multicenter PAS demonstrated this resurfacing is safe and durable. 10-year survivorship for males less than 55 years old is 98.3% (95% CI 95.9–100%)


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1287 - 1295
1 Oct 2009
Langton DJ Sprowson AP Joyce TJ Reed M Carluke I Partington P Nargol AVF

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


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_12 | Pages 11 - 11
1 Oct 2019
Wyles CC Paradise CR Masters TL Patel R Abdel MP Trousdale RT Sierra RJ
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Introduction. Adverse local tissue reactions (ALTR) can result in devastating soft tissue and osseous destruction, while potentially increasing the risk of concomitant periprosthetic joint infection (PJI). The aims of this study were to evaluate cobalt (Co) and chromium (Cr) levels generated in simulators from metal-on-polyethylene (MoP) and ceramic-on-polyethylene (CoP) constructs, and determine their impact on native tissues and PJI risk through evaluation of human adipose-derived mesenchymal stem cells (AMSCs) and Staphylococcus epidermidis isolates. Methods. Ten hip simulator constructs were assembled with 36-mm high-offset femoral heads, highly cross-linked polyethylene liners, and titanium stems. Five constructs used CoCr femoral heads and five used ceramic. Constructs were submerged in bovine serum (BS) and run for 1,000,000 cycles. Samples of BS were collected and evaluated for CoCr concentration. Various concentrations of CoCr were chosen for further assessment of cytotoxicity and growth impact on AMSCs and S. epidermidis and compared to inert SiO2. Results. After 1,000,000 cycles, mean MoP and CoP Co concentration was 2264 ng/mL and 0.6 ng/mL, respectively (p<0.001). Mean MoP and CoP Cr concentration was 217 ng/mL and 4.3 ng/mL, respectively (p<0.001). Mean MoP Co:Cr ratio was 10. Co nanoparticles were significantly more toxic to human AMSCs than control SiO2 in a dose-response manner (p<0.001). S. epidermidis growth was not significantly impacted by Co concentrations derived from the simulators. Conclusions. MoP constructs built in ideal conditions generated substantial CoCr debris, highlighting a baseline risk with these implants that may be exacerbated by host factors or imperfect surgical technique. Evaluation of impact on AMSCs suggests that debris levels produced under ideal conditions can be cytotoxic. Additionally, these concentrations did not potentiate or inhibit S. epidermidis growth, suggesting elevated PJI rates with ALTR may be related to other factors potentially associated with tissue necrosis. For any tables or figures, please contact the authors directly