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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


Bone & Joint Research
Vol. 9, Issue 3 | Pages 146 - 151
1 Mar 2020
Waldstein W Koller U Springer B Kolbitsch P Brodner W Windhager R Lass R

Aims. Second-generation metal-on-metal (MoM) articulations in total hip arthroplasty (THA) were introduced in order to reduce wear-related complications. The current study reports on the serum cobalt levels and the clinical outcome at a minimum of 20 years following THA with a MoM (Metasul) or a ceramic-on-polyethylene (CoP) bearing. Methods. The present study provides an update of a previously published prospective randomized controlled study, evaluating the serum cobalt levels of a consecutive cohort of 100 patients following THA with a MoM or a CoP articulation. A total of 31 patients were available for clinical and radiological follow-up examination. After exclusion of 11 patients because of other cobalt-containing implants, 20 patients (MoM (n = 11); CoP (n = 9)) with a mean age of 69 years (42 to 97) were analyzed. Serum cobalt levels were compared to serum cobalt levels five years out of surgery. Results. The median cobalt concentration in the MoM group was 1.04 μg/l (interquartile range (IQR) 0.64 to 1.70) at a mean of 21 years (20 to 24) postoperatively and these values were similar (p = 0.799) to cobalt levels at five years. In the CoP control group, the median cobalt levels were below the detection limit (< 0.3 μg/l; median 0.15 μg/l, IQR 0.15 to 0.75) at 20 years. The mean Harris Hip Score was 91.4 points (61 to 100) in the MoM group and 92.8 points (63 to 100) in the CoP group. Conclusion. This study represents the longest follow-up series evaluating the serum cobalt levels after 28 mm head MoM bearing THA and shows that serum cobalt concentrations remain at low levels at a mean of 21 years (20 to 24) after implantation. Cite this article:Bone Joint Res. 2020;9(3):145–150


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_I | Pages - 54
1 Mar 2002
Lazennec J Gleizes V Poupon J Saillant G
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Purpose: A significant increase in serum cobalt level has been reported after metal-on-metal total hip arthroplasty with wide individual variability related to activity level, mechanical conditions of the implant, and urinary elimination of cobalt. We studied serum cobalt levels over time to further analyse these factors. Material and methods: The Metazul® prosthesis was implanted in 119 patients (72 men and 47 women, 12 bilateral implantations) (131 implants). We selected 50 patients (27 men and 23 women, mean age 53 years) who had two blood samples after the procedure allowing an assessment of the serum cobalt kinetics. Other chromium-cobalt implants, vitamin B12 intake, renal failure, or haematological disorders were recorded. An activity questionnaire was filled out by the patients at the time of the blood sample. Samples were drawn with a special kit to avoid metal contamination. The detection limit was 1 nmol/L (0.06 μg/L) with direct electrothermic atomic spectrometric absorption. Results: In the overall series, serum cobalt level was 44 nmol/L for a physiological level in a control population of 4.28 nmol/L. The difference was significant (p < 0.0001) between the levels observed before surgery and after 18 months implantation. There was no significant correlation with the indication for arthroplasty, presence of dislocation or subdislocation, functional outcome or radiographic findings. Activity level the week before sampling did not influence the results. For the 50 cases evaluated longitudinally, four groups of patients could be identified. The first group (29 patients) had a serum cobalt level below 50 nmol/L over the entire study period. The second group (nine patients) had a level greater than 50 nmol/L followed by a decline ending with a final level below 50 nmol/L. In the third group (six patients) serum cobalt was greater than 50 nmol/L with no trend to a decline. In the fourth group (six patients) the cobalt levels were very high (greater than 150 nmol/L). Discussion: The six patients in the fourth group were very particular. There were three patients with secondary bilateral implants with a late peak in serum cobalt, one with an impingement on the acetabular rim, one with renal failure, and one who had a very high level of physical activity. The first group had what appears to be a favourable course, similar to the second group where a stabilisation phenomenon could be operating. An explanation in the third group is difficult but could involve a third segment abrasion phenomenon. Conclusion: Longitudinal analysis of serum cobalt levels provides more information than point measures in patients with metal-on-metal arthroplasties. Intercurrent mechanical phenomena can be detected; unexpected behaviour of the metal-on-metal junction can be suspected in certain patients


The Journal of Bone & Joint Surgery British Volume
Vol. 79-B, Issue 2 | Pages 316 - 321
1 Mar 1997
Brodner W Bitzan P Meisinger V Kaider A Gottsauner-Wolf F Kotz R

We determined serum cobalt levels in 55 patients by atomic absorption spectrophotometry before and after implantation of uncemented total hip arthroplasties. In a randomised, prospective trial 27 wrought Co-28Cr-6Mo-0.2C metal-on-metal articulations were compared with 28 ceramic-on-polyethylene hips which did not contain cobalt. Other sources of iatrogenic cobalt loading were excluded. The metal-on-metal group produced detectable serum cobalt levels (median 1.1 μg/l after one year) which were significantly different (p < 0.0001) from those of the ceramic-on-polyethylene control group (median below detection limit of 0.3 μg/l after one year). Our findings indicate that metal-on-metal bearings generate some systemic release of cobalt


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_II | Pages 120 - 120
1 Apr 2005
Lazannec J Poupon J Saillant G
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Purpose: Serum cobalt and chromium levels after metal-on-metal implantations are not well known. There has been little data on the correlation with clinical and radiological surveillance. This prospective analysis followed the changes in serum cobalt, chromium, and titanium levels in order to ascertain the behaviour of the femoral implant and the bearing. Material and methods: The series included 292 patients followed for 27–72 months who were free of kidney failure, were not given vitamin B12 supplementation, and did not have occupational exposure. The same cemented implants were used in all patients: titanium femoral stem, Metasuly heads (28 mm). Serum samples were drawn preoperatively and at three, six and twelve months then annually (systematic activity questionnaire). The limit for detection of serum cobalt and chromium was 1 nmol/l (0.05μg/l); for titanium it was 30 nmol/l (1.4m/l). Results: The main problems encountered were two impingements and two femoral loosenings. Four patterns were identified in the time courses of serum cobalt and chromium. In decreasing order, they were: type 1, low initial level (< 50 nmol/l) then no change; type 2, high initial level (> 50 nmol/l) then decrease; type 3 low initial level then progression; type 4, high initial level then further elevation. Bilateral prostheses showed a particular pattern with elevation after the second implantation. The serum levels rapidly returned to normal after revision in the two impingement cases. The titanium levels were correlated with femoral problems which were not initially detected on the x-rays. Discussion: Correlation between serum cobalt level and wear is difficult to establish. There was no specific pattern after dislocation. The kinetics showed certain patterns with possible prognostic significance: groups 1 (metallic silence) and 2 (breaking-in) would correspond to favourable evolution; type 3 would be difficult to interpret (missed impingement, foreign body, articular decoaptation or major change in activity level); type 4 is highly suggestive of premature wear or a biological problem (excepting bilateral implants). It is important to monitor serum cobalt and titanium simultaneously to detect an interface problem and or femoral loosening


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_I | Pages 79 - 79
1 Jan 2004
Lee PTH Clarke MT Arora A Villar RN
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Aims: Metal-on-Metal (MOM) bearings for Total Hip Arthroplasty (THA) are known to elevate the serum concentrations of metal ions, raising concern about possible long-term side-effects. One potential modifier of ion release is the bearing diameter used. Resurfacing MOM bearings have a large surface area available for corrosion, but may benefit from improved lubrication and reduced production of corrodible wear debris. The net effect of these two variables on metal ion release is unknown. Methods: In this study, we measured the serum cobalt and chromium levels from 22 large diameter MOM resurfacing arthroplasties (Cormet2000 & Birmingham Hip Resurfacing) and compared them to 22 THA (Ultima) with a bearing diameter of 28 mm. Patients were prospectively matched for activity level, weight and date after surgery. All were at least 6 months after surgery. Results: At a median of 16 months (range 7 to 56) after resurfacing arthroplasty, we found the median serum cobalt and chromium levels to be 38 nmol/l (14 to 44) and 53 nmol/l (23 to 165) respectively. Both these figures were significantly greater than the levels after 28 mm MOM THA, which were 22 nmol/l (15 to 87, p=0.021) and 19 nmol/l (2 to 58, p< 0.001) for cobalt and chromium respectively. Conclusions: As the upper limit of normal in patients without implants is typically 5 nmol/l, both groups had significantly raised metal ion levels, albeit at a relatively short median follow-up period. Large diameter MOM bearings resulted in a greater systemic release of cobalt and chromium ions than did small diameter bearings. This may be of relevance for potential long-term side-effects. It is not known to what extent this difference is due to corrosion of the component surfaces or of the wear particles produced


Orthopaedic Proceedings
Vol. 90-B, Issue SUPP_I | Pages 125 - 125
1 Mar 2008
Paliwal M Allan DG Barnhart B Trammell R
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Purpose: The purpose of this study was to monitor serum cobalt (Co) and chromium (Cr) levels in patients after metal-on-metal resurfacing hip arthroplasty with the Cormet 2000® prosthesis, and to evaluate the effect of patient characteristics, prosthesis characteristics, clinical and radiographic measures on metal levels. Methods: Serum Co and Cr levels were determined in 32 patients with Cormet resurfacing prostheses at 0.5, 1 and 2 years postoperatively using ICP-MS and are reported as & #61549;g/L. Control levels were measured in 20 patients without implants. Results: Medium Co and Cr were 0.21 and 0.16 in controls without implants. Medium Co at 6 months (2.65), 1 year (3.62) and 2 years (2.80), and Cr at 6 months (3.74), 1 year (4.73) and 2 years (4.68) were signifi-cantly increased in the Cormet group when compared to control levels (p < .0001). Metal levels did not correlate with cup inclination, component position, head size, age, weight, sex or Harris Hip scores. Markedly elevated Co (35, 63) and Cr (13, 70) levels were found in two patients with excessive cup abduction. In addition, one patient with a loose implant that required revision had markedly elevated Co (19) and Cr (44) levels. Conclusions: Significantly increased levels of cobalt and chromium were released from Cormet 2000 articulations at all time points. Excessive cup abduction was associated with markedly elevated ion levels indicating that accurate cup placement is an important consideration in resurfacing arthroplasty. The significantly increased trace metal levels following resurfacing with the Cormet prosthesis is a concern and warrants further monitoring


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 3 - 4
1 Mar 2010
Parsley BK Allan DG Dyrstad B Milbrandt JC
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Purpose: Metal-on-metal (MOM) bearing surfaces release ions locally and into the systemic circulation. This elevation raises concern about the long term effects of elevated metal ions. The goal of the present study was to monitor serum cobalt (Co) and chromium (Cr) levels in patients after MOM resurfacing hip arthroplasty with the Cormet 2000 prosthesis. We present here pilot data on Co and Cr levels in patients with bilateral versus unilateral hip resurfacing devices. Method: We prospectively collected patient characteristics, outcome, and serum samples from device implanted subjects at 6 months, 1, 2, and 3 years following surgery. Unilateral patients had one implant during the entire course of follow-up and bilateral patients were included after the second implant surgery was performed. Serum Co/Cr levels were determined using high-resolution inductively coupled plasma mass spectrometry. Students t-test was used to compare ion levels in two groups based on the number of resurfacing implants (bilateral versus unilateral). Results: 41 unilateral and 9 bilateral subjects were enrolled and followed for serum Co and Cr levels. In general, Co/Cr levels were increased at all time points when compared to control levels in both groups. Bilateral subjects had average serum levels concentrations significantly higher than those observed for unilateral cases (Co: 5.99 vs 2.56 μg/L (p=0.0001); Cr: 6.66 vs 3.60 (p=0.0009). Conclusion: Elevated serum Co/Cr levels were observed at all time points following implantation in both groups and serum levels were nearly 2 times higher in the bilateral group. Based on these preliminary findings, patients undergoing bilateral total hip resurfacing arthroplasty may need to be monitored more closely than those patients receiving unilateral devices. In addition, these bilateral cases may be at a greater risk of ion level toxicities than the unilateral population


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 228 - 228
1 Dec 2013
Ando W Yamamoto K Koyama T Fudo K Tsujimoto T Aihara M Ohzono K
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Metal on metal total hip arthroplasty provides the potential improvement in articular wear and the use of large-diameter femoral heads following the prospect for reduction in the risk of dislocation. The purpose of this study was to compare the clinical and radiographic outcomes as well as serum metal ion level between the two different component designs with small and large femoral heads in metal on metal total hip arthroplasty. We studied 39 patients with large head (Magnum®, Biomet; cup size minus 6 mm) and 37 patients with small head (M2a taper®, Biomet; 28 or 32 mm head) of metal on metal total hip arthroplasty between December 2009 to October 2011 with follow-up of 2.1 years (1.0–3.3 years) after surgery. Harris Hip Score, UCLA activity score, EQ-5D, radiographic assessment, and serum cobalt and chromium ion levels were evaluated. Harris Hip Score, UCLA activity score, and EQ-5D were improved after surgery in small and large head groups, however, no significant differences were observed between both groups. Cup inclination was below 50 degree in all prosthesis. No loosening and no osteolysis were observed. Cobalt and chromium ion was not detected before surgery; however, metal ion levels of both groups were increased after surgery in time dependent manner. There was no significant difference between two groups at one year after surgery. One patient in each group showed the increase of cobalt ion level over 7 ppb (15.4 ppb, 12.9 ppb) without any clinical symptom including pain. Cup inclination was 29 degree in both patients and cup anteversion was 38 and 41 degree, respectively. There was no significant difference of ion levels between both groups. No dislocation was observed in large head group while one dislocation occurred in small head group. No patients required the revision surgery. This metal on metal component, especially with large femoral heads, showed the good clinical results at the maximum follow up of 3.3 year after surgery. However, the ion level of two patients increased over 7 ppb and longer follow-up will be needed


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 240 - 240
1 May 2009
Allan D Dyrstad BW Milbrandt JC Parsley BK
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Metal-on-metal (MOM) hip resurfacing devices are known to release metal ions locally and into the systemic circulation. Previous studies suggest that larger prosthetic head size will correlate to reduced wear properties and may result in lower systemic release of metal ions. This project assessed the effect of femoral head size on serum cobalt (Co) and chromium (Cr) levels in subjects after unilateral hip resurfacing with the Cormet 2000 prosthesis. We prospectively collected patient characteristics, outcome, and serum samples from device implanted subjects at six months, one, two, and three years following surgery. Serum Co/Cr levels were determined using high-resolution inductively coupled plasma mass spectrometry. Students t-test was used to compare ion levels in two groups based on femoral head size. Thirty-five subjects (twenty male) were followed. Co/Cr levels were increased at all time points when compared to control levels. A significant negative correlation was observed between Co and Cr levels and femoral head size. Co/Cr levels in subjects with larger femoral heads were significantly lower when compared to those implanted with smaller heads (Co, −35.8%; Cr, −33.0%). This correlated with significantly higher Co/Cr levels in females versus males, with females receiving significantly smaller heads on average. Elevated serum Co/Cr levels were observed at all time points following implantation and in females and in subjects with femoral heads


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_13 | Pages 18 - 18
1 Oct 2018
Chalmers BP Mangold DG Hanssen AD Pagnano MW Trousdale RT Abdel MP
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Introduction. Modular dual-mobility constructs reduce the risk of dislocation after total hip arthroplasty (THA). However, questions about metal ions from the cobalt-chrome (CoCr) liner persist, and are particularly germane to patients being revised for adverse local tissue reactions (ALTR) to metal. We determined the mid-term serum Co and Cr levels after modular dual-mobilities used in revision and complex primary THAs, and specifically included patients revised for ALTR. Methods. Serum Co and Cr levels were measured prospectively in 22 patients with a modular dual-mobility construct and a ceramic femoral head. Patients with CoCr heads or contralateral THAs with CoCr heads were excluded. Mean age 64 years with 50% female. The mean follow-up was 4 years. Indications for modular dual-mobility were: periprosthetic joint infection treated with 2-stage exchange and subsequent reimplantation (n=8), ALTR revision (n=7), complex primary THA (n=6), and periprosthetic femoral fracture (n=1). Mean preoperative Co and Cr in patients revised for an ALTR were 29.7 µg/L and 21.5 µg/L, respectively. Results. Mean Co and Cr levels were 0.26 µg/L and 0.82 µg/L, respectively, at most recent follow-up. No patients had a cobalt level ≥1 µg/L. Only one patient had a chromium level ≥1 µg/L. That patient's chromium level was 12 µg/L at 57 months after revision THA for ALTR (and decreased 10-fold from a preoperative Cr of 113 µg/L). Conclusion. At a mean of 4 years, no patient with a modular dual-mobility construct and ceramic femoral head had elevated cobalt levels, including seven patients revised specifically for ALTR. While further studies are required, we support selective use of a modular dual-mobility construct in revision and complex primary THAs for patients at high risk for instability. Summary. At a mean of 4 years after revision or complex primary THAs with a modular dual-mobility construct and a ceramic head, none of 22 patients had serum cobalt levels that measured ≥1 µg/L


The Bone & Joint Journal
Vol. 101-B, Issue 6_Supple_B | Pages 57 - 61
1 Jun 2019
Chalmers BP Mangold DG Hanssen AD Pagnano MW Trousdale RT Abdel MP

Aims

Modular dual-mobility constructs reduce the risk of dislocation after revision total hip arthroplasty (THA). However, questions about metal ions from the cobalt-chromium (CoCr) liner persist, and are particularly germane to patients being revised for adverse local tissue reactions (ALTR) to metal. We determined the early- to mid-term serum Co and Cr levels after modular dual-mobility components were used in revision and complex primary THAs, and specifically included patients revised for ALTR.

Patients and Methods

Serum Co and Cr levels were measured prospectively in 24 patients with a modular dual-mobility construct and a ceramic femoral head. Patients with CoCr heads or contralateral THAs with CoCr heads were excluded. The mean age was 63 years (35 to 83), with 13 patients (54%) being female. The mean follow-up was four years (2 to 7). Indications for modular dual-mobility were prosthetic joint infection treated with two-stage exchange and subsequent reimplantation (n = 8), ALTR revision (n = 7), complex primary THA (n = 7), recurrent instability (n = 1), and periprosthetic femoral fracture (n = 1). The mean preoperative Co and Cr in patients revised for an ALTR were 29.7 μg/l (2 to 146) and 21.5 μg/l (1 to 113), respectively.


The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 89 - 96
1 Mar 2024
Heckmann ND Chung BC Liu KC Chen XT Lovro LR Kistler NM White E Christ AB Longjohn DB Oakes DA Lieberman JR

Aims. Modular dual-mobility (DM) articulations are increasingly used during total hip arthroplasty (THA). However, concerns remain regarding the metal liner modularity. This study aims to correlate metal artifact reduction sequence (MARS)-MRI abnormalities with serum metal ion levels in patients with DM articulations. Methods. A total of 45 patients (50 hips) with a modular DM articulation were included with mean follow-up of 3.7 years (SD 1.2). Enrolled patients with an asymptomatic, primary THA and DM articulation with over two years’ follow-up underwent MARS-MRI. Each patient had serum cobalt, chromium, and titanium levels drawn. Patient satisfaction, Oxford Hip Score, and Forgotten Joint Score-12 (FJS-12) were collected. Each MARS-MRI was independently reviewed by fellowship-trained musculoskeletal radiologists blinded to serum ion levels. Results. Overall, two patients (4.4%) had abnormal periprosthetic fluid collections on MARS-MRI with cobalt levels > 3.0 μg/l. Four patients (8.9%) had MARS-MRI findings consistent with greater trochanteric bursitis, all with cobalt levels < 1.0 μg/l. A seventh patient had a periprosthetic fluid collection with normal ion levels. Of the 38 patients without MARS-MRI abnormalities, 37 (97.4%) had cobalt levels < 1.0 μg/l, while one (2.6%) had a cobalt level of 1.4 μg/l. One patient (2.2%) had a chromium level > 3.0 μg/l and a periprosthetic fluid collection. Of the 41 patients with titanium levels, five (12.2%) had titanium levels > 5.0 μg/l without associated MARS-MRI abnormalities. Conclusion. Periprosthetic fluid collections associated with elevated serum cobalt levels in patients with asymptomatic DM articulations occur infrequently (4.4%), but further assessment is necessary due to implant heterogeneity. Cite this article: Bone Joint J 2024;106-B(3 Supple A):89–96


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_I | Pages 76 - 76
1 Jan 2004
Lee PTH Clarke MT Arora A Villar RN
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Aims: Cobalt (Co) and chromium (Cr) ion associated carcinogenesis and chromosomal damage in animals have raised concerns that metal-on-metal (MOM) total hip replacement (THR) in humans may produce the same effects over time. Considering that the risks may be related to the level of these ions in the body, this study compared the serum Co and Cr levels in patients with unilateral versus bilateral 28 mm diameter MOM THR.

Methods: All patients having THR at our institution were prospectively registered on a computerised database. From our database, 108 Ultima MOM THR with 28 mm CoCrMo bearing were identified. After patient review in clinic and before blood results were known, patient matching was performed by date after surgery, activity level and weight. Using these stringent criteria, 11 unilateral THR could be adequately matched with 11 bilateral THR. Blood serum was taken with full anti-contamination protocols and serum analysed via inductively coupled plasma mass spectrometry (ICP-MS) Statistical analysis used the Mann-Whitney U test.

Results: The median serum Co level after unilateral MOM THR was 22 nmol (range 15 to 37 nmol) compared to 42 nmol (range 19 to 221 nmol) for bilateral MOM THR (p=0.001). The median serum Cr level after unilateral MOM THR was 19 nmol (range 2 to 35 nmol) compared to 52 nmol (range 19 to 287 nmol) for bilateral MOM THR (p=0.04).

Conclusions: This study has shown that the serum Co and Cr levels in patients with bilateral MOM THR are significantly higher than those with unilateral MOM THR. With levels of up to 50 times the upper of limit of normal, this finding may be of relevance for the development of potential long-term side effects.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 352 - 352
1 Mar 2004
Lee P Clarke M Arora A Villar R
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Aims: Cobalt (Co) and chromium (Cr) ion associated carcinogenesis and chromosomal damage in animals has raised concerns that metal-on-metal (MOM) total hip replacement (THR) in humans may produce the same effects over time. Considering that the risks may be related to the level of these ions in the body, this study compared the serum Co and Cr levels in patients with unilateral versus bilateral 28 mm diameter MOM THR. Methods: All patients having THR at our institution were prospectively registered on a computerised database. From our database, 108 Ultima MOM THR with 28 mm CoCrMo bearing were identiþed. After patient review in clinic and before blood results were known, patient matching was performed by date after surgery, activity level and weight. Using these stringent criteria, 11 unilateral THR could be adequately matched with 11 bilateral THR. Blood serum was taken with full anti-contamination protocols and serum analysed via atomic absorption spectrometry. Statistical analysis used the Mann-Whitney U test. Results: The median serum Co level after unilateral MOM THR was 22 nmol (range 15 to 37 nmol) compared to 42 nmol (range 19 to 221 nmol) for bilateral MOM THR (p=0.001). The median serum Cr level after unilateral MOM THR was 19 nmol (range 2 to 35 nmol) compared to 52 nmol (range 19 to 287 nmol) for bilateral MOM THR (p=0.04). Conclusions: This study has shown that the serum Co and Cr levels in patients with bilateral MOM THR are signiþcantly higher than those with unilateral MOM THR. With levels of up to 50 times the upper limit of normal, this þnding may be of relevance for the potential development of long-term side effects.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_14 | Pages 21 - 21
1 Nov 2021
DeBenedetti A Della Valle CJ Jacobs JJ Nam D
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The purpose of this randomized controlled trial was to evaluate serum metal ion levels in patients undergoing THA with either a standard or modular dual-mobility bearing. Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or a standard polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Only patients without a prior history of metal implants in their body were eligible for inclusion, thus isolating serum metal ions to the prosthesis itself. Serum metal ion levels were drawn pre-operatively and at 1 year postoperatively. Power analysis determined that 40 patients (20 in each group) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power assuming a pooled standard deviation of 0.31 ppb and alpha=0.05; an additional 30% were enrolled to account for potential dropouts. 53 patients were enrolled, with 22 patients in the modular dual-mobility group and 20 in the standard cohort with data available at one-year. No differences in the serum cobalt (0.17 ppb [range 0.07 to 0.50] vs. 0.19 ppb [range 0.07 to 0.62], p = 0.51) or chromium levels (0.19 ppb [range 0.05 to 0.56] vs. 0.16 ppb [range 0.05 to 0.61], p = 0.23) were identified. At 1 year postoperatively, no differences in serum cobalt or chromium levels were identified with this design of a modular dual mobility bearing when compared to a standard polyethylene bearing


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 13 - 13
19 Aug 2024
DeBenedetti A Weintraub MT Valle CJD Jacobs JJ Nam D
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The purpose of this randomized controlled trial was to evaluate serum metal levels in patients undergoing total hip arthroplasty (THA) with a conventional compared to a modular dual-mobility bearing. Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or conventional polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Serum metal levels were drawn pre-operatively then annually for a minimum of two years postoperatively. An a priori power analysis determined that 40 patients (20 per cohort) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power. Forty-six patients were randomized to a modular dual-mobility (n=25) or conventional bearing (n=21) with 40 at a minimum follow-up of two years. No differences in serum cobalt (mean 0.14 ppb [range, 0.075–0.29] vs. 0.20 ppb [range, 0.075–0.57], p=0.39) or chromium levels (mean 0.14 ppb [range, 0.05–0.50] vs. 0.12 ppb [range, 0.05–0.35], p=0.65) were identified between the modular dual-mobility and conventional cohorts, respectively. There was no statistically significant difference in serum Co or Cr at two years postoperatively in subjects implanted with a ceramic head and this particular dual mobility bearing in comparison to a ceramic head and a conventional acetabular component. While modest expected elevations in serum Co and Cr were observed in the dual mobility group, in no case did the Co level exceed the laboratory reference range nor the threshold of one part per billion that has been associated with adverse local tissue reactions to mechanically-assisted crevice corrosion


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 66 - 66
19 Aug 2024
Terhune EB Sutter EG Balkissoon R Pallante GD Specht L Leikin JB Kwon YM Lewallen DG Gerlinger TL Jacobs JJ
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Ceramic-on-ceramic (CoC) articulations in total hip arthroplasty (THA) have low wear, but the unique risk of fracture. After revision for CoC fracture, ceramic third bodies can lead to runaway wear of cobalt chrome (CoCr) causing extremely elevated blood cobalt. We present five cases of ceramic liner fractures revised to a CoCr head associated with the rapid development of severe cobalt toxicity. We identified 5 cases of fractured CoC THA treated with revision to CoCr on highly cross-linked polyethylene (HXLPE) – three to conventional bearings and two to modular dual mobility bearings (CoCr acetabular liner, CoCr femoral head, and HXLPE). Mean follow up was 2.5 years after CoCr/HXLPE re-revision. Symptoms of cobalt toxicity occurred at average 9.5 months after revision for ceramic fracture (range 6–12). All patients developed vision and hearing loss, balance difficulties, and peripheral neuropathy. Several had cardiomyopathy, endocrinopathy, and local skin discoloration. Two reported hip pain. Re-revision for cobalt toxicity occurred at an average of 22 months (range 10–36) after revision for ceramic fracture. Average serum cobalt level at re-revision was 991 μg/L (range 734–1302, normal <1 μg/L). All CoCr heads exhibited massive wear with asphericity; deep tissues exhibited prominent metallosis. Treatment consisted of debridement and revision to a ceramic head with HXLPE. Serum cobalt improved to an average of 25 μg/L at final follow up. All patients reported partial improvement in vision and hearing; peripheral neuropathy and balance did not recover. Systemic cobalt toxicity is a rare but devastating complication of ceramic fracture in THA treated with cobalt-alloy bearings. Cobalt alloy bearings should be avoided in this setting. The diagnosis of systemic cobalt toxicity requires a high index of suspicion and was typically delayed following systemic symptoms. Debridement and revision to a ceramic-on-HXLPE leads to improvement but not resolution of cobalt toxicity complications


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 45 - 45
23 Jun 2023
Lieberman JR
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Modular dual mobility (DM) articulations are increasingly utilized during total hip arthroplasty (THA). However, concerns remain regarding the metal liner modularity. This study aims to correlate metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) abnormalities with serum metal ion levels in patients with DM articulations. All patients with an asymptomatic, primary THA and DM articulation with >2-year follow-up underwent MARS-MRI of the operative hip. Each patient had serum cobalt, chromium, and titanium levels drawn. Patient satisfaction, Oxford Hip Score, and Forgotten Joint Score-12 (FJS-12) were collected. Each MARS-MRI was independently reviewed by fellowship-trained musculoskeletal radiologists blinded to serum ion levels. Forty-five patients (50 hips) with a modular DM articulation were included with average follow-up of 3.7±1.2 years. Two patients (4.4%) had abnormal periprosthetic fluid collections on MARS-MRI with cobalt levels >3.0 μg/L. Four patients (8.9%) had MARS-MRI findings consistent with greater trochanteric bursitis, all with cobalt levels < 1.0 μg/L. A seventh patient had a periprosthetic fluid collection with normal ion levels. Of the 38 patients without MARS-MRI abnormalities, 37 (97.4%) had cobalt levels <1.0 μg/L, while one (2.6%) had a cobalt level of 1.4 μg/L. One patient (2.2%) had a chromium level >3.0 μg/L and a periprosthetic fluid collection. Of the 41 patients with titanium levels, five (12.2%) had titanium levels >5.0 μg/L without associated MARS-MRI abnormalities. Periprosthetic fluid collections associated with elevated serum cobalt levels in patients with asymptomatic dual mobility articulations occur infrequently (4.4%), but further assessment of these patients is necessary. Level of Evidence: Level IV


The Bone & Joint Journal
Vol. 100-B, Issue 7 | Pages 898 - 902
1 Jul 2018
Lachiewicz PF O’Dell JA

Aims. To report our experience with trunnion corrosion following metal-on-polyethylene total hip arthroplasty, in particular to report the spectrum of presentation and determine the mean time to presentation. Patients and Methods. We report the presenting symptoms and signs, intraoperative findings, and early results and complications of operative treatment in nine patients with a mean age of 74 years (60 to 86). The onset of symptoms was at a mean of seven years (3 to 18) after index surgery. Results. Patients presented with a variety of symptoms including pain, limp and rash. The preoperative mean serum cobalt level was 7.1 ppb (2.2 to 12.8) and mean serum chromium level was 2.2 ppb (0.5 to 5.2). Metal artifact reduction sequence (MARS) MRI showed fluid collection and possible pseudotumour formation in five hips, fluid collection in two hips, and synovitis/debris in one hip, with no MRI in one patient. Acetabular revision was performed in three patients, six patients underwent liner and head exchange only. The postoperative metal levels decreased in all patients: mean cobalt 0.5 ppb (0 to 1.8) and mean chromium 0.9 ppb (0 to 2.6) at a mean of five months (3 to 8) postoperatively. Seven patients had good pain relief and no complications at one year. There were two major complications requiring reoperation: acute infection at six weeks, for which the patient required two-stage reimplantation; and recurrent dislocation, for which the patient was revised to a dual mobility component. Conclusion. Trunnion corrosion in metal-on-polyethylene THA has a range of presenting symptoms, and may present later than previously described. A high index of suspicion is warranted, and serum cobalt and chromium levels are recommended for diagnosis. Patients should be counselled about possible postoperative complications. Cite this article: Bone Joint J 2018;100-B:898–902