The Journal of Arthroplasty xxx (2015) xxx–xxx
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The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement Rami Madanat, MD, PhD a,b, Daniel K. Hussey, BA a, Gabrielle S. Donahue, BA a, Hollis G. Potter, MD c, Robert Wallace, MD d, Charles R. Bragdon, PhD a,b, Orhun K. Muratoglu, PhD a,b, Henrik Malchau, MD, PhD a,b a
Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts Harvard Medical School, Department of Orthopaedic Surgery, Boston, Massachusetts Department of Radiology and Imaging, Hospital for Special Surgery, New York, New York d Sportsmed SA, Stepney, South Australia b c
a r t i c l e
i n f o
Article history: Received 10 February 2015 Accepted 27 April 2015 Available online xxxx Keywords: metal-on-metal hip arthroplasty bilateral ASR adverse local tissue reaction
a b s t r a c t The purpose of this study was to evaluate whether patients with bilateral metal-on-metal (MoM) hip replacements have symmetric adverse local tissue reactions (ALTRs) at follow-up. An MRI of both hips was performed at a mean time of six years after surgery in 43 patients. The prevalence and severity of ALTRs were found to be similar in simultaneous hips but differences were observed in sequential hips. The order and timing of sequential hip arthroplasties did not affect the severity of ALTRs. Thus, in addition to metal ion exposure from an earlier MoM implant other factors may also play a role in the progression of ALTRs. Bilateral implants should be given special consideration in risk stratification algorithms for management of patients with MoM hip arthroplasty. © 2015 Elsevier Inc. All rights reserved.
Adverse local tissue reaction (ALTR) is a significant cause of failure in metal-on-metal (MoM) hip implants [1]. Previous studies have shown the prevalence of these adverse reactions based on MRI to be as high as 69% in some series of MoM hip systems [2]. The ASR hip resurfacing system and the ASR XL total hip replacement (DePuy Orthopaedics, Warsaw, Indiana) were commercially introduced in 2003. This system was recalled in 2010 due to a higher than expected revision rate at five years, after an estimated 93,000 acetabular components had been implanted worldwide [3,4]. Systemic levels of chromium (Cr) and cobalt (Co) ions have been correlated with the linear and volumetric wear rates of the femoral component in MoM arthroplasty [5,6]. There are still unanswered questions regarding the susceptibility of some patients to metal ions [7]. A recent in vitro study found that CoCr metal debris may be more toxic to cells in the presence of previous exposure to Co ions [8]. It remains unclear if patients with bilateral metal-on-metal implants who develop an ALTR on one side will also develop an adverse reaction on the contralateral side. The first purpose of this observational cohort study was to evaluate whether patients with simultaneous bilateral ASR hip replacements One or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to http://dx.doi.org/10.1016/j.arth.2015.04.036. Reprint requests: Henrik Malchau, M.D., Ph.D., Orthopedic Department, Massachusetts General Hospital, 55 Fruit Street, GRJ 1126, Boston, Massachusetts, 02114–2696.
have symmetric soft tissue findings on MRI at follow-up. The second purpose was to assess if patients with sequential ASR hip replacements have differences in MRI findings regarding prevalence and severity of ALTRs. Our first hypothesis was that MRI findings would be similar in both hips for patients with simultaneous procedures. We further hypothesized that ALTR severity would correlate to the time interval from surgery in cases with sequential arthroplasties, and that longer intervals would result in more severe ALTRs in accordance with in vitro observations mentioned above. Materials and Methods The study population consisted of 45 patients with bilateral hip replacements enrolled in a multicenter follow-up study of the Articular Surface Replacement (ASR) Hip System (ASR resurfacing and ASR XL total hip replacement, DePuy Orthopaedics, Warsaw, Indiana). There were 21 patients with bilateral ASR hip resurfacings (HRs), 22 with bilateral total hip arthroplasties (THAs) and 2 with a combination of HR on one side and THA on the other. These 2 patients were excluded as they were not considered comparable to the rest of the study population. Thus, a total of 43 patients were included in the analysis. Patients from one center were included in this study and enrollment took place from 2012 to 2014. All patients had an MRI of the hip performed using metal artifact reduction (MARS) protocol at a mean time of 6.3 years after surgery (range 2.8–9.9 years). The EQ-5D, Harris Hip Score (HHS), UCLA activity score, and VAS Pain score (0–10) were also obtained for all patients in order to assess subjective health related
http://dx.doi.org/10.1016/j.arth.2015.04.036 0883-5403/© 2015 Elsevier Inc. All rights reserved.
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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quality of life, hip function, activity, and pain levels, respectively. The abduction angle of the acetabular components was determined from digital plain radiographs of all patients using mdesk software (RSA Biomedical, Umeå, Sweden). MR images were assessed for the presence of ALTRs and these were classified according to the Anderson classification system, which has the highest intra-observer and inter-observer reliability of the currently used systems [9,10]. In this classification, a mild ALTR (C1) is defined as a periprosthetic soft tissue mass with no hyperintense T2W fluid signal or a fluid filled periprosthetic cavity less than 5 cm in maximal diameter. A moderate ALTR (C2) is a periprosthetic soft tissue mass/ fluid-filled cavity greater than 5 cm in diameter or C1 lesion with either (1) muscle atrophy or edema in any muscle other than short external rotators or (2) bone marrow edema hyperintense on STIR (short tau inversion recovery) sequences. Severe ALTRs (C3) are any of the following: fluid-filled cavities extending through deep fascia, a tendon avulsion, intermediate T1W soft tissue cortical or marrow signal, or fracture [9]. This classification was originally devised to correspond with the decision and urgency to treat, such that C1 means no immediate intervention but follow-up is recommended, C2 implies that an elective revision of the hip should be considered, and C3 means that there is an urgent need for revision surgery. In addition to the Anderson grade, the volume of synovitis was calculated from axial images using the ROI volume function of OsiriX Imaging Software (OsiriX 6.0.2, Pixmeo, Geneva, Switzerland) and was validated using a previously published manual segmentation method [11,12]. The synovial thickness of the ALTR was also determined [13]. Synovial thickness and synovial volumes have been shown to correlate with ALVAL scores as well as intraoperative tissue damage [13,14]. MRI assessment was performed by one of the authors with two years of experience and validated by a musculoskeletal radiologist with more than ten years of experience with MARS MRI. Informed consent was obtained from all patients and the study was approved by the Institutional Review Board. A t-test for two independent samples was used to compare normally distributed variables and a Mann–Whitney U test was used for nonparametric continuous variables. When comparing between hips, paired samples t-tests were used for parametric variables and the Wilcoxon Sign Rank Test was used for non-parametric variables. The chi-square test was used in the assessment of categorical variables. For sequential hips, univariate logistic regression was used to assess the relationship between which hip had a larger ALTR volume (1st or 2nd hip) and the following six variables: time from 1st surgery to MRI, time between hip surgeries, abduction angle of 1st hip, difference in hip abduction angles, Co ion level, and Cr ion level. Interobserver reliability for the assessment of categorical variables was performed using Cohen’s kappa (κ) and for continuous variables using Pearson’s r. A P value b 0.05 was considered significant. Statistical analyses were performed using SPSS version 17.0. Results Of the 43 patients with bilateral ASR hip arthroplasties, 16 (9 ASR XL, 7 ASR) had the procedures performed simultaneously and 27 (13 ASR XL, 14 ASR) sequentially. The mean age of the patients at the time of MRI was 65 (range 37–84) and 18 (42%) were women. The mean time between surgeries for the sequential cases was 20 months (range 3–64 months). There were 41 hips with C1 (19 ASR, 22 ASR XL), 14 hips with C2 (8 ASR, 6 ASR XL), and 6 (all ASR XL) hips with C3 ALTRs. The interobserver reliability for assessment of synovial thickness and volume was high (r = 0.91 and r = 0.96, respectively) and the interobserver reliability for assessment of ALTR grade (κ = 0.64) was substantial. Of the 43 patients, 27 (63%) (15 ASR XL, 12 ASR) patients had a bilateral ALTR, 9 (21%) (3 ASR XL, 6 ASR) had a unilateral ALTR and 7 (16%) (4 ASR XL, 3 ASR) had no ALTR findings on either side. The mean acetabular component abduction angle was 43.3° (range 21.9°–52.4°) in the simultaneous group and 43.4° (range 20.5°–62.0°)
in the sequential group (P = 0.96). Also, the mean difference in abduction angle between left and right hips was 7.6° (0.0°–27.1°) in the simultaneous group and 5.6° (range 0.5°–13.6°) in the sequential group (P = 0.75). The mean head size was 51 mm (range 40–59 mm) in the simultaneous group and 51 mm (range 45–59 mm) in the sequential group (P = 0.69). The mean difference between head sizes of the left and right hip in the simultaneous group was 0.13 mm (range 0–4 mm) and 0.59 mm (range 0–11 mm) for the sequential group (P = 0.98). The mean Co ion levels were 7.8 μg/L (range, 0.8–25.9 μg/L) and 4.7 μg/L (range, 1.1–17.5 μg/L) for simultaneous and sequential hips, respectively (P = 0.20). Similarly, the mean Cr ion levels were 3.0 μg/L (range, 0.6–7.9 μg/L) and were 2.8 μg/L (range, 0.0–9.0 μg/L) for simultaneous and sequential hips, respectively (P = 0.43). The majority of patients with simultaneous bilateral arthroplasties had ALTRs of equal Anderson grade on both sides (75%) as did more than half of the patients (56%) with sequential arthroplasties (P = 0.20). Six patients (14%) had a difference of one Anderson grade (C1/C2 or C2/C3) between hips (Fig. 1) and only three patients (7%) had a difference of more than one Anderson grade (C1/C3). Also, all patients with a C3 or C2 ALTR on one side also had ALTR findings on the contralateral side (Table 1). The mean volume of synovitis in the patients with ALTRs was 11.1 cm3 (range, 0.7–74.5 cm 3). The difference in volume of synovitis between hips was 3.5 cm3 (95% CI: 0–12.1 cm 3) for simultaneous and 8.0 cm 3 (95% CI: 0–32.6 cm 3) for sequential cases (P = 0.92). There was a high correlation in the ALTR volume for left and right hips of simultaneous cases (R 2 = 0.96), whereas the correlation in volume for the first and second hips of sequential cases was not substantial (R 2 = 0.12) (Fig. 2A and B). A little over half (52%) of the patients in the sequential group with an ALTR had a larger ALTR volume in the contralateral second hip and the remainder had a larger volume in the first hip. However, the overall mean ALTR volumes were similar for both hips in sequential cases (8.1 cm3 vs 8.3 cm3 for first and second hips, respectively, P = 0.96). Time between surgeries (P = 0.41), time from 1st surgery to MRI (P = 0.30), abduction angle of 1st hip (P = 0.93), difference in abduction angles between hips (P = 0.99), Co ion level (P = 0.48), and Cr ion level (P = 0.88) were not predictors for which hip had a larger ALTR volume. The mean synovial thickness in the patients with ALTRs was 3.2 mm (range, 1.2–6.4 mm). There was no difference in synovial thickness between left and right hips (P = 0.83). The mean difference in synovial thickness between hips was 1.2 mm (95% CI: 0–4.2 mm) for the simultaneous group and 1.3 mm (95% CI: 0–3.9 mm) for the sequential cases (P = 0.71). There was a low correlation in the synovial thickness for left and right hips of simultaneous cases (R2 = 0.25) as well as for the first and second hips of sequential cases (R2 = 0.25) (Fig. 3A and B). Looking at ASR and ASR XL implants separately, the difference in volume of synovitis between ASR hips was 3.8 cm 3 for simultaneous and 3.9 cm 3 for sequential cases (P = 0.69). In ASR XL patients, the difference in volume of synovitis between hips was 3.2 cm 3 for simultaneous and 12.4 cm3 for sequential cases (P = 0.43). The mean difference in synovial thickness between ASR hips was 1.1 mm for the simultaneous group and 0.7 mm for the sequential cases (P = 0.44). For ASR XL patients, the difference in synovial thickness between hips was 1.2 mm for the simultaneous group and 1.9 mm for the sequential cases (P = 0.21). The overall subjective outcomes of the patients in the study based on PROMs were good to excellent. The mean EQ-5D, Harris Hip Score (HHS), and UCLA activity score were 0.79 (range 0.12–1.0), 84.5 (range 52–100), and 5.9 (range 3–10), respectively. The mean VAS Pain score was low 1.16 (range 0–10). Discussion The first aim of this study was to evaluate if patients with simultaneous bilateral ASR hip replacements have symmetrical soft tissue findings on MRI. The second purpose was to assess if sequential hip
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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Table 1 Grid Showing the Distribution of ALTR Findings in Left and Right Hips According to Severity in All 43 Patients. Right Hip
Left Hip
Fig. 1. AP hip radiographs of a 79 year-old female (A and B) with bilateral ASR XL THA. The right hip THA was performed 7 years prior to imaging and the left hip one year after the right hip. Coronal STIR MR image of the right and left hips show a larger ALTR on the left side classified as C2, whereas the smaller ALTR on the right side was classified as C1 (C and D). Similarly, the axial STIR MR images show the larger extracapsular ALTR in the left hip (E and F).
arthroplasty results in asymmetric MRI findings with more severe ALTRs in the later hip. We demonstrated that in patients with bilateral ASR implants the prevalence and severity of ALTRs appear to be similar in both hips at mid-term with some differences in sequential cases.
No ALTR C1 C2 C3
No ALTR
C1
C2
C3
9 2 0 0
7 13 3 1
0 2 4 0
0 2 1 1
We also showed that the order and timing of sequential ASR hip arthroplasties do not seem to affect the severity of subsequent ALTRs. The prevalence of ALTRs in this cohort of bilateral ASR patients was 70%. This is at the higher end of the 36%–69% reported prevalence in previous studies assessing MRI findings in patients with mainly unilateral ASR implants [15–17]. One might expect a larger prevalence of adverse reactions in patients with bilateral implants as it has been shown that blood metal ion levels are also higher in the case of two MoM articulations and CoCr wear particles as well as Co ions stimulate apoptosis and toxicology related genes [8,18]. The severity distribution of ALTR findings was similar to previous studies of MoM implants as most patients had mild or moderate ALTRs and only a few had ALTRs classified as severe [16,17,19]. Most of the patients in the current study who had undergone simultaneous arthroplasty procedures were found to have ALTRs of equal severity when present. Similarly, more than half the patients with sequential arthroplasties also had similar adverse soft tissue reactions around both hip joints. This observation was true for Anderson grade, overall ALTR volume and synovial thickness. The larger proportion of patients with differences in ALTR severity in the sequential arthroplasty group compared to the simultaneous group would imply that there is a temporal relationship between exposure to the implant and ALTR development. The surprising finding was that the probability of the earlier vs. the later hip having a more severe ALTR was close to 50%. When assessing each of the two implant types (ASR and ASR XL) separately, there were also no significant differences in ALTR volume or synovial thickness between left and right hips for sequential or simultaneous patients. Only a few studies have assessed and quantified the volume of synovitis or synovial thickness from MR images of MoM patients [12–14,16]. The mean volume of synovitis and synovial thickness in the current patient population with ALTRs were similar to the values reported for patients with no subjective symptoms in a previous study [12]. This is further supported by the good to excellent outcomes of patients in the current study. There is growing evidence that ALTR volume and synovial thickness may be clinically relevant in predicting both tissue damage and patient symptoms, which may be especially relevant in the longitudinal follow-up of these patients [12–14]. Unlike the Anderson classification, both the Matthies and Hauptfteisch pseudotumor grading systems have included the pseudotumor wall thickness as a criterion in the classification of severity [10]. Although this probably increases the clinical relevance of the grading severity per se, the reliability of the grading is inferior to Anderson classification [10]. Thus, in this study we chose to use the Anderson classification and perform an additional separate assessment of volume and synovial thickness. The current study had some limitations. The MR imaging in the current study was performed at different times for different patients with the time from surgery to MRI ranging from 2.8 to 9.9 years. On the other hand the aim of this study was not to assess longitudinal or temporal changes in ALTRs but rather to investigate differences between left and right hips of simultaneously and sequentially performed arthroplasties. Furthermore the MR imaging of both hips in each patient was performed at the same time, which was more important for the scope of the study. The inclusion of multiple imaging assessment time points would be expected to demonstrate ALTRs of varying severity,
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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Fig. 2. The relationship between ALTR volume in left and right hips for simultaneous arthroplasties (A) and between the first and second hips for sequential arthroplasties (B).
further increasing the significance of the ALTR findings if symmetrical. Another limitation of the study was that due to the relatively small number of patients we were unable to reliably assess the relationship between ALTR volume and PROMs. However, the clinical relevance of such an analysis might have been limited as the PROMs were generally good to excellent and there is growing evidence that silent ALTRs are not a rare occurrence [16,17]. Finally, our MARS MRI assessment did not include newer sequences such as multiacquisition variableresonance image combination (MAVRIC) [20]. Such sequences have been shown to further reduce susceptibility to artifact and improve visualization of small but potentially biologically significant intracapsular reactions that might otherwise be obscured [21]. The study of bilateral patients is clinically relevant as patients with bilateral hip implants are usually included and often grouped together with unilateral patients in studies of MoM hip arthroplasty. Occasionally, bilateral cases are excluded as it is simpler to assess patients with only one side operated due to potential confounding effects of a second hip implant on both subjective outcomes and especially on blood metal ions [15,22,23]. Patients with bilateral implants can be a valuable source of information about MoM implants as both implants are in a similar in vivo environment and each implant has a reliable control thereby minimizing the number of confounding factors akin to epidemiological twin studies. Studying these patients may also shed some light on the manner in which the immune system addresses metal debris. The presence of wear debris in the peri-implant region leads to phagocytosis of particulate debris by macrophages and activation of these cells stimulates the release of various mediators such as free radicals, nitric oxide and bone resorbing mediators [24]. Additionally, metal debris and metal ions can also activate the immune system by inducing a delayed type IV hypersensitivity reaction [25]. Based on this foreign body response, it is likely that patients with simultaneous bilateral implants display metal debris at a similar level in both hips and in a larger volume when compared to patients with staged procedures. Our results support this as patients with simultaneous bilateral implants had similar
severity ALTRs on both sides. It is possible that in the case of sequential implants a type IV hypersensitivity reaction also plays a role and contributes to the ALTR differences, which may be related to patient characteristics. To our knowledge, this is the first comprehensive study of ALTRs in a subcohort of patients with bilateral MoM implants. A significant number of patients have bilateral MoM hip replacements and the clinical scenario of a patient presenting with symptoms on only one side is not uncommon. Van Der Straeten et al noted that Co and Cr ion levels in unilateral and bilateral MoM resurfacing patients are different, but the role of metal ions in the clinical management of these patients is still controversial [18,22]. The most recently published risk stratification algorithm for management of patients with metal-onmetal hip arthroplasty does not address the issue of patients with bilateral implants [26]. Based on our study, patients with bilateral implants are likely to develop similar ALTRs in both hips. Thus, if a patient has been diagnosed with an ALTR on one side we believe that their contralateral hip should routinely be considered moderate to high risk and followed-up accordingly. We also suggest that for patients with sequential or simultaneous bilateral MoM hips, both hips should be followed-up at similar intervals based on the risk stratification of the more severe hip. Currently we are unable to predict which ALTRs will progress from mild and moderate to severe. Some studies have demonstrated that asymptomatic ALTRs after MoM THA and HR show little change over one year [27,28], whereas others have demonstrated increases in size over a mean follow-up time of 20–26 months especially for larger ALTRs [29,30]. Interestingly, in the study by Reito et al examining longitudinal soft tissue changes in ASR patients using MRI, the proportion of patients with progressive changes in MRI was higher in bilateral patients (38%) compared to unilateral patients (11%), but the overall change in pseudotumor classification was rare (11% hips) [27]. On the other hand, evidence in the literature does suggest that most patients with severe adverse tissue reactions present early on and if patients with normal initial MRI examinations develop an adverse reaction, this usually happens at around 7–10 years after surgery [31].
Fig. 3. The relationship between ALTR synovial thickness in left and right hips for simultaneous arthroplasties (A) and between the first and second hips for sequential arthroplasties (B).
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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In addition to metal ion exposure from an earlier MoM implant, other factors may also play a role in the progression of ALTRs. In patients with bilateral ASR implants, problems on one side are likely to be a harbinger of progressive adverse events on the contralateral side. Furthermore, due to the often symmetrical prevalence of ALTR findings, bilateral implants should be given special consideration in the risk stratification algorithm for management of patients with metal-on-metal hip arthroplasty. Acknowledgements This study was supported by DePuy Orthopaedics, Warsaw, Indiana. We thank Clinical Research Project Manager Slav Lerner for his help with the study and Marc Bragdon for technical assistance. References 1. Langton DJ, Jameson SS, Joyce TJ, et al. Accelerating failure rate of the ASR total hip replacement. J Bone Joint Surg Br 2011;93(8):1011. 2. Chang EY, McAnally JL, Van Horne JR, et al. Relationship of plasma metal ions and clinical and imaging findings in patients with ASR XL metal-on-metal total hip replacements. J Bone Joint Surg Am 2015;95(22):2013. 3. Whitwell GS, Shine A, Young SK. The articular surface replacement implant recall: a United Kingdom district hospital experience. Hip Int 2012;22(4):362. 4. Huang DC, Tatman P, Mehle S, et al. Cumulative revision rate is higher in metal-onmetal THA than metal-on-polyethylene THA: analysis of survival in a community registry. Clin Orthop Relat Res 1920;471(6):2013. 5. De Smet K, De Haan R, Calistri A, et al. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am 2008; 90(Suppl. 4):202. 6. Langton DJ, Joyce TJ, Jameson SS, et al. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br 2011;93(2):164. 7. Haddad FS. Metal-on-metal: more questions than answers. Bone Joint J 2013;95B(8):1009. 8. Posada OM, Gilmour D, Tate RJ, et al. CoCr wear particles generated from CoCr alloy metal-on-metal hip replacements, and cobalt ions stimulate apoptosis and expression of general toxicology-related genes in monocyte-like U937 cells. Toxicol Appl Pharmacol 2014;281(1):125. 9. Anderson H, Toms AP, Cahir JG, et al. Grading the severity of soft tissue changes associated with metal-on-metal hip replacements: reliability of an MR grading system. Skelet Radiol 2011;40(3):303. 10. van der Weegen W, Brakel K, Horn RJ, et al. Comparison of different pseudotumor grading systems in a single cohort of metal-on-metal hip arthroplasty patients. Skelet Radiol 2014;43(2):149. 11. Potter HG, Nestor BJ, Sofka CM, et al. Magnetic resonance imaging after total hip arthroplasty: evaluation of periprosthetic soft tissue. J Bone Joint Surg Am 1947;86A(9):2004.
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12. Nawabi DH, Hayter CL, Su EP, et al. Magnetic resonance imaging findings in symptomatic versus asymptomatic subjects following metal-on-metal hip resurfacing arthroplasty. J Bone Joint Surg Am 2013;95(10):895. 13. Nawabi DH, Gold S, Lyman S, et al. MRI predicts ALVAL and tissue damage in metalon-metal hip arthroplasty. Clin Orthop Relat Res 2014;472(2):471. 14. Hayter CL, Gold SL, Koff MF, et al. MRI findings in painful metal-on-metal hip arthroplasty. AJR Am J Roentgenol 2012;199(4):884. 15. Fox CM, Bergin KM, Kelly GE, et al. MRI findings following metal on metal hip arthroplasty and their relationship with metal ion levels and acetabular inclination angles. J Arthroplast 2014;29(8):1647. 16. Chang EY, McAnally JL, Van Horne JR, et al. Metal-on-metal total hip arthroplasty: do symptoms correlate with MR imaging findings? Radiology 2012;265(3):848. 17. Wynn-Jones H, Macnair R, Wimhurst J, et al. Silent soft tissue pathology is common with a modern metal-on-metal hip arthroplasty. Acta Orthop 2011;82(3):301. 18. Van Der Straeten C, Grammatopoulos G, Gill HS, et al. The 2012 Otto Aufranc Award: the interpretation of metal ion levels in unilateral and bilateral hip resurfacing. Clin Orthop Relat Res 2013;471(2):377. 19. van der Weegen W, Smolders JM, Sijbesma T, et al. High incidence of pseudotumours after hip resurfacing even in low risk patients; results from an intensified MRI screening protocol. Hip Int 2013;23(3):243. 20. Choi SJ, Koch KM, Hargreaves BA, et al. Metal artifact reduction with MAVRIC SL at 3-T MRI in patients with hip arthroplasty. AJR Am J Roentgenol 2015;204(1):140. 21. Hayter CL, Koff MF, Shah P, et al. MRI after arthroplasty: comparison of MAVRIC and conventional fast spin-echo techniques. AJR Am J Roentgenol 2011;197(3): W405. 22. Hart AJ, Sabah SA, Sampson B, et al. Surveillance of patients with metal-on-metal hip resurfacing and total hip prostheses: a prospective cohort study to investigate the relationship between blood metal ion levels and implant failure. J Bone Joint Surg Am 2014;96(13):1091. 23. Reito A, Moilanen T, Puolakka T, et al. Repeated metal ion measurements in patients with high risk metal-on-metal hip replacement. Int Orthop 2014;38(7): 1353. 24. Sethi RK, Neavyn MJ, Rubash HE, et al. Macrophage response to cross-linked and conventional UHMWPE. Biomaterials 2003;24(15):2561. 25. Hallab N, Merritt K, Jacobs JJ. Metal sensitivity in patients with orthopaedic implants. J Bone Joint Surg Am 2001;83-A(3):428. 26. Kwon YM, Lombardi AV, Jacobs JJ, et al. Risk stratification algorithm for management of patients with metal-on-metal hip arthroplasty: consensus statement of the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and the Hip Society. J Bone Joint Surg Am 2014;96(1):e4. 27. Reito A, Elo P, Puolakka T, et al. Repeated magnetic resonance imaging in 154 hips with large-diameter metal-on-metal hip replacement. Acta Orthop 2014;1. 28. van der Weegen W, Brakel K, Horn RJ, et al. Asymptomatic pseudotumours after metal-on-metal hip resurfacing show little change within one year. Bone Joint J 2013;95-B(12):1626. 29. Almousa SA, Greidanus NV, Masri BA, et al. The natural history of inflammatory pseudotumors in asymptomatic patients after metal-on-metal hip arthroplasty. Clin Orthop Relat Res 2013;471(12):3814. 30. Hasegawa M, Miyamoto N, Miyazaki S, et al. Longitudinal magnetic resonance imaging of pseudotumors following metal-on-metal total hip arthroplasty. J Arthroplast 2014;29(12):2236. 31. Thomas MS, Wimhurst JA, Nolan JF, et al. Imaging metal-on-metal hip replacements: the Norwich experience. HSS J 2013;9(3):247.
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement Rami Madanat, MD, PhD a,b, Daniel K. Hussey, BA a, Gabrielle S. Donahue, BA a, Hollis G. Potter, MD c, Robert Wallace, MD d, Charles R. Bragdon, PhD a,b, Orhun K. Muratoglu, PhD a,b, Henrik Malchau, MD, PhD a,b a
Harris Orthopaedic Laboratory, Massachusetts General Hospital, Boston, Massachusetts Harvard Medical School, Department of Orthopaedic Surgery, Boston, Massachusetts Department of Radiology and Imaging, Hospital for Special Surgery, New York, New York d Sportsmed SA, Stepney, South Australia b c
a r t i c l e
i n f o
Article history: Received 10 February 2015 Accepted 27 April 2015 Available online xxxx Keywords: metal-on-metal hip arthroplasty bilateral ASR adverse local tissue reaction
a b s t r a c t The purpose of this study was to evaluate whether patients with bilateral metal-on-metal (MoM) hip replacements have symmetric adverse local tissue reactions (ALTRs) at follow-up. An MRI of both hips was performed at a mean time of six years after surgery in 43 patients. The prevalence and severity of ALTRs were found to be similar in simultaneous hips but differences were observed in sequential hips. The order and timing of sequential hip arthroplasties did not affect the severity of ALTRs. Thus, in addition to metal ion exposure from an earlier MoM implant other factors may also play a role in the progression of ALTRs. Bilateral implants should be given special consideration in risk stratification algorithms for management of patients with MoM hip arthroplasty. © 2015 Elsevier Inc. All rights reserved.
Adverse local tissue reaction (ALTR) is a significant cause of failure in metal-on-metal (MoM) hip implants [1]. Previous studies have shown the prevalence of these adverse reactions based on MRI to be as high as 69% in some series of MoM hip systems [2]. The ASR hip resurfacing system and the ASR XL total hip replacement (DePuy Orthopaedics, Warsaw, Indiana) were commercially introduced in 2003. This system was recalled in 2010 due to a higher than expected revision rate at five years, after an estimated 93,000 acetabular components had been implanted worldwide [3,4]. Systemic levels of chromium (Cr) and cobalt (Co) ions have been correlated with the linear and volumetric wear rates of the femoral component in MoM arthroplasty [5,6]. There are still unanswered questions regarding the susceptibility of some patients to metal ions [7]. A recent in vitro study found that CoCr metal debris may be more toxic to cells in the presence of previous exposure to Co ions [8]. It remains unclear if patients with bilateral metal-on-metal implants who develop an ALTR on one side will also develop an adverse reaction on the contralateral side. The first purpose of this observational cohort study was to evaluate whether patients with simultaneous bilateral ASR hip replacements One or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to http://dx.doi.org/10.1016/j.arth.2015.04.036. Reprint requests: Henrik Malchau, M.D., Ph.D., Orthopedic Department, Massachusetts General Hospital, 55 Fruit Street, GRJ 1126, Boston, Massachusetts, 02114–2696.
have symmetric soft tissue findings on MRI at follow-up. The second purpose was to assess if patients with sequential ASR hip replacements have differences in MRI findings regarding prevalence and severity of ALTRs. Our first hypothesis was that MRI findings would be similar in both hips for patients with simultaneous procedures. We further hypothesized that ALTR severity would correlate to the time interval from surgery in cases with sequential arthroplasties, and that longer intervals would result in more severe ALTRs in accordance with in vitro observations mentioned above. Materials and Methods The study population consisted of 45 patients with bilateral hip replacements enrolled in a multicenter follow-up study of the Articular Surface Replacement (ASR) Hip System (ASR resurfacing and ASR XL total hip replacement, DePuy Orthopaedics, Warsaw, Indiana). There were 21 patients with bilateral ASR hip resurfacings (HRs), 22 with bilateral total hip arthroplasties (THAs) and 2 with a combination of HR on one side and THA on the other. These 2 patients were excluded as they were not considered comparable to the rest of the study population. Thus, a total of 43 patients were included in the analysis. Patients from one center were included in this study and enrollment took place from 2012 to 2014. All patients had an MRI of the hip performed using metal artifact reduction (MARS) protocol at a mean time of 6.3 years after surgery (range 2.8–9.9 years). The EQ-5D, Harris Hip Score (HHS), UCLA activity score, and VAS Pain score (0–10) were also obtained for all patients in order to assess subjective health related
http://dx.doi.org/10.1016/j.arth.2015.04.036 0883-5403/© 2015 Elsevier Inc. All rights reserved.
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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quality of life, hip function, activity, and pain levels, respectively. The abduction angle of the acetabular components was determined from digital plain radiographs of all patients using mdesk software (RSA Biomedical, Umeå, Sweden). MR images were assessed for the presence of ALTRs and these were classified according to the Anderson classification system, which has the highest intra-observer and inter-observer reliability of the currently used systems [9,10]. In this classification, a mild ALTR (C1) is defined as a periprosthetic soft tissue mass with no hyperintense T2W fluid signal or a fluid filled periprosthetic cavity less than 5 cm in maximal diameter. A moderate ALTR (C2) is a periprosthetic soft tissue mass/ fluid-filled cavity greater than 5 cm in diameter or C1 lesion with either (1) muscle atrophy or edema in any muscle other than short external rotators or (2) bone marrow edema hyperintense on STIR (short tau inversion recovery) sequences. Severe ALTRs (C3) are any of the following: fluid-filled cavities extending through deep fascia, a tendon avulsion, intermediate T1W soft tissue cortical or marrow signal, or fracture [9]. This classification was originally devised to correspond with the decision and urgency to treat, such that C1 means no immediate intervention but follow-up is recommended, C2 implies that an elective revision of the hip should be considered, and C3 means that there is an urgent need for revision surgery. In addition to the Anderson grade, the volume of synovitis was calculated from axial images using the ROI volume function of OsiriX Imaging Software (OsiriX 6.0.2, Pixmeo, Geneva, Switzerland) and was validated using a previously published manual segmentation method [11,12]. The synovial thickness of the ALTR was also determined [13]. Synovial thickness and synovial volumes have been shown to correlate with ALVAL scores as well as intraoperative tissue damage [13,14]. MRI assessment was performed by one of the authors with two years of experience and validated by a musculoskeletal radiologist with more than ten years of experience with MARS MRI. Informed consent was obtained from all patients and the study was approved by the Institutional Review Board. A t-test for two independent samples was used to compare normally distributed variables and a Mann–Whitney U test was used for nonparametric continuous variables. When comparing between hips, paired samples t-tests were used for parametric variables and the Wilcoxon Sign Rank Test was used for non-parametric variables. The chi-square test was used in the assessment of categorical variables. For sequential hips, univariate logistic regression was used to assess the relationship between which hip had a larger ALTR volume (1st or 2nd hip) and the following six variables: time from 1st surgery to MRI, time between hip surgeries, abduction angle of 1st hip, difference in hip abduction angles, Co ion level, and Cr ion level. Interobserver reliability for the assessment of categorical variables was performed using Cohen’s kappa (κ) and for continuous variables using Pearson’s r. A P value b 0.05 was considered significant. Statistical analyses were performed using SPSS version 17.0. Results Of the 43 patients with bilateral ASR hip arthroplasties, 16 (9 ASR XL, 7 ASR) had the procedures performed simultaneously and 27 (13 ASR XL, 14 ASR) sequentially. The mean age of the patients at the time of MRI was 65 (range 37–84) and 18 (42%) were women. The mean time between surgeries for the sequential cases was 20 months (range 3–64 months). There were 41 hips with C1 (19 ASR, 22 ASR XL), 14 hips with C2 (8 ASR, 6 ASR XL), and 6 (all ASR XL) hips with C3 ALTRs. The interobserver reliability for assessment of synovial thickness and volume was high (r = 0.91 and r = 0.96, respectively) and the interobserver reliability for assessment of ALTR grade (κ = 0.64) was substantial. Of the 43 patients, 27 (63%) (15 ASR XL, 12 ASR) patients had a bilateral ALTR, 9 (21%) (3 ASR XL, 6 ASR) had a unilateral ALTR and 7 (16%) (4 ASR XL, 3 ASR) had no ALTR findings on either side. The mean acetabular component abduction angle was 43.3° (range 21.9°–52.4°) in the simultaneous group and 43.4° (range 20.5°–62.0°)
in the sequential group (P = 0.96). Also, the mean difference in abduction angle between left and right hips was 7.6° (0.0°–27.1°) in the simultaneous group and 5.6° (range 0.5°–13.6°) in the sequential group (P = 0.75). The mean head size was 51 mm (range 40–59 mm) in the simultaneous group and 51 mm (range 45–59 mm) in the sequential group (P = 0.69). The mean difference between head sizes of the left and right hip in the simultaneous group was 0.13 mm (range 0–4 mm) and 0.59 mm (range 0–11 mm) for the sequential group (P = 0.98). The mean Co ion levels were 7.8 μg/L (range, 0.8–25.9 μg/L) and 4.7 μg/L (range, 1.1–17.5 μg/L) for simultaneous and sequential hips, respectively (P = 0.20). Similarly, the mean Cr ion levels were 3.0 μg/L (range, 0.6–7.9 μg/L) and were 2.8 μg/L (range, 0.0–9.0 μg/L) for simultaneous and sequential hips, respectively (P = 0.43). The majority of patients with simultaneous bilateral arthroplasties had ALTRs of equal Anderson grade on both sides (75%) as did more than half of the patients (56%) with sequential arthroplasties (P = 0.20). Six patients (14%) had a difference of one Anderson grade (C1/C2 or C2/C3) between hips (Fig. 1) and only three patients (7%) had a difference of more than one Anderson grade (C1/C3). Also, all patients with a C3 or C2 ALTR on one side also had ALTR findings on the contralateral side (Table 1). The mean volume of synovitis in the patients with ALTRs was 11.1 cm3 (range, 0.7–74.5 cm 3). The difference in volume of synovitis between hips was 3.5 cm3 (95% CI: 0–12.1 cm 3) for simultaneous and 8.0 cm 3 (95% CI: 0–32.6 cm 3) for sequential cases (P = 0.92). There was a high correlation in the ALTR volume for left and right hips of simultaneous cases (R 2 = 0.96), whereas the correlation in volume for the first and second hips of sequential cases was not substantial (R 2 = 0.12) (Fig. 2A and B). A little over half (52%) of the patients in the sequential group with an ALTR had a larger ALTR volume in the contralateral second hip and the remainder had a larger volume in the first hip. However, the overall mean ALTR volumes were similar for both hips in sequential cases (8.1 cm3 vs 8.3 cm3 for first and second hips, respectively, P = 0.96). Time between surgeries (P = 0.41), time from 1st surgery to MRI (P = 0.30), abduction angle of 1st hip (P = 0.93), difference in abduction angles between hips (P = 0.99), Co ion level (P = 0.48), and Cr ion level (P = 0.88) were not predictors for which hip had a larger ALTR volume. The mean synovial thickness in the patients with ALTRs was 3.2 mm (range, 1.2–6.4 mm). There was no difference in synovial thickness between left and right hips (P = 0.83). The mean difference in synovial thickness between hips was 1.2 mm (95% CI: 0–4.2 mm) for the simultaneous group and 1.3 mm (95% CI: 0–3.9 mm) for the sequential cases (P = 0.71). There was a low correlation in the synovial thickness for left and right hips of simultaneous cases (R2 = 0.25) as well as for the first and second hips of sequential cases (R2 = 0.25) (Fig. 3A and B). Looking at ASR and ASR XL implants separately, the difference in volume of synovitis between ASR hips was 3.8 cm 3 for simultaneous and 3.9 cm 3 for sequential cases (P = 0.69). In ASR XL patients, the difference in volume of synovitis between hips was 3.2 cm 3 for simultaneous and 12.4 cm3 for sequential cases (P = 0.43). The mean difference in synovial thickness between ASR hips was 1.1 mm for the simultaneous group and 0.7 mm for the sequential cases (P = 0.44). For ASR XL patients, the difference in synovial thickness between hips was 1.2 mm for the simultaneous group and 1.9 mm for the sequential cases (P = 0.21). The overall subjective outcomes of the patients in the study based on PROMs were good to excellent. The mean EQ-5D, Harris Hip Score (HHS), and UCLA activity score were 0.79 (range 0.12–1.0), 84.5 (range 52–100), and 5.9 (range 3–10), respectively. The mean VAS Pain score was low 1.16 (range 0–10). Discussion The first aim of this study was to evaluate if patients with simultaneous bilateral ASR hip replacements have symmetrical soft tissue findings on MRI. The second purpose was to assess if sequential hip
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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Table 1 Grid Showing the Distribution of ALTR Findings in Left and Right Hips According to Severity in All 43 Patients. Right Hip
Left Hip
Fig. 1. AP hip radiographs of a 79 year-old female (A and B) with bilateral ASR XL THA. The right hip THA was performed 7 years prior to imaging and the left hip one year after the right hip. Coronal STIR MR image of the right and left hips show a larger ALTR on the left side classified as C2, whereas the smaller ALTR on the right side was classified as C1 (C and D). Similarly, the axial STIR MR images show the larger extracapsular ALTR in the left hip (E and F).
arthroplasty results in asymmetric MRI findings with more severe ALTRs in the later hip. We demonstrated that in patients with bilateral ASR implants the prevalence and severity of ALTRs appear to be similar in both hips at mid-term with some differences in sequential cases.
No ALTR C1 C2 C3
No ALTR
C1
C2
C3
9 2 0 0
7 13 3 1
0 2 4 0
0 2 1 1
We also showed that the order and timing of sequential ASR hip arthroplasties do not seem to affect the severity of subsequent ALTRs. The prevalence of ALTRs in this cohort of bilateral ASR patients was 70%. This is at the higher end of the 36%–69% reported prevalence in previous studies assessing MRI findings in patients with mainly unilateral ASR implants [15–17]. One might expect a larger prevalence of adverse reactions in patients with bilateral implants as it has been shown that blood metal ion levels are also higher in the case of two MoM articulations and CoCr wear particles as well as Co ions stimulate apoptosis and toxicology related genes [8,18]. The severity distribution of ALTR findings was similar to previous studies of MoM implants as most patients had mild or moderate ALTRs and only a few had ALTRs classified as severe [16,17,19]. Most of the patients in the current study who had undergone simultaneous arthroplasty procedures were found to have ALTRs of equal severity when present. Similarly, more than half the patients with sequential arthroplasties also had similar adverse soft tissue reactions around both hip joints. This observation was true for Anderson grade, overall ALTR volume and synovial thickness. The larger proportion of patients with differences in ALTR severity in the sequential arthroplasty group compared to the simultaneous group would imply that there is a temporal relationship between exposure to the implant and ALTR development. The surprising finding was that the probability of the earlier vs. the later hip having a more severe ALTR was close to 50%. When assessing each of the two implant types (ASR and ASR XL) separately, there were also no significant differences in ALTR volume or synovial thickness between left and right hips for sequential or simultaneous patients. Only a few studies have assessed and quantified the volume of synovitis or synovial thickness from MR images of MoM patients [12–14,16]. The mean volume of synovitis and synovial thickness in the current patient population with ALTRs were similar to the values reported for patients with no subjective symptoms in a previous study [12]. This is further supported by the good to excellent outcomes of patients in the current study. There is growing evidence that ALTR volume and synovial thickness may be clinically relevant in predicting both tissue damage and patient symptoms, which may be especially relevant in the longitudinal follow-up of these patients [12–14]. Unlike the Anderson classification, both the Matthies and Hauptfteisch pseudotumor grading systems have included the pseudotumor wall thickness as a criterion in the classification of severity [10]. Although this probably increases the clinical relevance of the grading severity per se, the reliability of the grading is inferior to Anderson classification [10]. Thus, in this study we chose to use the Anderson classification and perform an additional separate assessment of volume and synovial thickness. The current study had some limitations. The MR imaging in the current study was performed at different times for different patients with the time from surgery to MRI ranging from 2.8 to 9.9 years. On the other hand the aim of this study was not to assess longitudinal or temporal changes in ALTRs but rather to investigate differences between left and right hips of simultaneously and sequentially performed arthroplasties. Furthermore the MR imaging of both hips in each patient was performed at the same time, which was more important for the scope of the study. The inclusion of multiple imaging assessment time points would be expected to demonstrate ALTRs of varying severity,
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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Fig. 2. The relationship between ALTR volume in left and right hips for simultaneous arthroplasties (A) and between the first and second hips for sequential arthroplasties (B).
further increasing the significance of the ALTR findings if symmetrical. Another limitation of the study was that due to the relatively small number of patients we were unable to reliably assess the relationship between ALTR volume and PROMs. However, the clinical relevance of such an analysis might have been limited as the PROMs were generally good to excellent and there is growing evidence that silent ALTRs are not a rare occurrence [16,17]. Finally, our MARS MRI assessment did not include newer sequences such as multiacquisition variableresonance image combination (MAVRIC) [20]. Such sequences have been shown to further reduce susceptibility to artifact and improve visualization of small but potentially biologically significant intracapsular reactions that might otherwise be obscured [21]. The study of bilateral patients is clinically relevant as patients with bilateral hip implants are usually included and often grouped together with unilateral patients in studies of MoM hip arthroplasty. Occasionally, bilateral cases are excluded as it is simpler to assess patients with only one side operated due to potential confounding effects of a second hip implant on both subjective outcomes and especially on blood metal ions [15,22,23]. Patients with bilateral implants can be a valuable source of information about MoM implants as both implants are in a similar in vivo environment and each implant has a reliable control thereby minimizing the number of confounding factors akin to epidemiological twin studies. Studying these patients may also shed some light on the manner in which the immune system addresses metal debris. The presence of wear debris in the peri-implant region leads to phagocytosis of particulate debris by macrophages and activation of these cells stimulates the release of various mediators such as free radicals, nitric oxide and bone resorbing mediators [24]. Additionally, metal debris and metal ions can also activate the immune system by inducing a delayed type IV hypersensitivity reaction [25]. Based on this foreign body response, it is likely that patients with simultaneous bilateral implants display metal debris at a similar level in both hips and in a larger volume when compared to patients with staged procedures. Our results support this as patients with simultaneous bilateral implants had similar
severity ALTRs on both sides. It is possible that in the case of sequential implants a type IV hypersensitivity reaction also plays a role and contributes to the ALTR differences, which may be related to patient characteristics. To our knowledge, this is the first comprehensive study of ALTRs in a subcohort of patients with bilateral MoM implants. A significant number of patients have bilateral MoM hip replacements and the clinical scenario of a patient presenting with symptoms on only one side is not uncommon. Van Der Straeten et al noted that Co and Cr ion levels in unilateral and bilateral MoM resurfacing patients are different, but the role of metal ions in the clinical management of these patients is still controversial [18,22]. The most recently published risk stratification algorithm for management of patients with metal-onmetal hip arthroplasty does not address the issue of patients with bilateral implants [26]. Based on our study, patients with bilateral implants are likely to develop similar ALTRs in both hips. Thus, if a patient has been diagnosed with an ALTR on one side we believe that their contralateral hip should routinely be considered moderate to high risk and followed-up accordingly. We also suggest that for patients with sequential or simultaneous bilateral MoM hips, both hips should be followed-up at similar intervals based on the risk stratification of the more severe hip. Currently we are unable to predict which ALTRs will progress from mild and moderate to severe. Some studies have demonstrated that asymptomatic ALTRs after MoM THA and HR show little change over one year [27,28], whereas others have demonstrated increases in size over a mean follow-up time of 20–26 months especially for larger ALTRs [29,30]. Interestingly, in the study by Reito et al examining longitudinal soft tissue changes in ASR patients using MRI, the proportion of patients with progressive changes in MRI was higher in bilateral patients (38%) compared to unilateral patients (11%), but the overall change in pseudotumor classification was rare (11% hips) [27]. On the other hand, evidence in the literature does suggest that most patients with severe adverse tissue reactions present early on and if patients with normal initial MRI examinations develop an adverse reaction, this usually happens at around 7–10 years after surgery [31].
Fig. 3. The relationship between ALTR synovial thickness in left and right hips for simultaneous arthroplasties (A) and between the first and second hips for sequential arthroplasties (B).
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
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In addition to metal ion exposure from an earlier MoM implant, other factors may also play a role in the progression of ALTRs. In patients with bilateral ASR implants, problems on one side are likely to be a harbinger of progressive adverse events on the contralateral side. Furthermore, due to the often symmetrical prevalence of ALTR findings, bilateral implants should be given special consideration in the risk stratification algorithm for management of patients with metal-on-metal hip arthroplasty. Acknowledgements This study was supported by DePuy Orthopaedics, Warsaw, Indiana. We thank Clinical Research Project Manager Slav Lerner for his help with the study and Marc Bragdon for technical assistance. References 1. Langton DJ, Jameson SS, Joyce TJ, et al. Accelerating failure rate of the ASR total hip replacement. J Bone Joint Surg Br 2011;93(8):1011. 2. Chang EY, McAnally JL, Van Horne JR, et al. Relationship of plasma metal ions and clinical and imaging findings in patients with ASR XL metal-on-metal total hip replacements. J Bone Joint Surg Am 2015;95(22):2013. 3. Whitwell GS, Shine A, Young SK. The articular surface replacement implant recall: a United Kingdom district hospital experience. Hip Int 2012;22(4):362. 4. Huang DC, Tatman P, Mehle S, et al. Cumulative revision rate is higher in metal-onmetal THA than metal-on-polyethylene THA: analysis of survival in a community registry. Clin Orthop Relat Res 1920;471(6):2013. 5. De Smet K, De Haan R, Calistri A, et al. Metal ion measurement as a diagnostic tool to identify problems with metal-on-metal hip resurfacing. J Bone Joint Surg Am 2008; 90(Suppl. 4):202. 6. Langton DJ, Joyce TJ, Jameson SS, et al. Adverse reaction to metal debris following hip resurfacing: the influence of component type, orientation and volumetric wear. J Bone Joint Surg Br 2011;93(2):164. 7. Haddad FS. Metal-on-metal: more questions than answers. Bone Joint J 2013;95B(8):1009. 8. Posada OM, Gilmour D, Tate RJ, et al. CoCr wear particles generated from CoCr alloy metal-on-metal hip replacements, and cobalt ions stimulate apoptosis and expression of general toxicology-related genes in monocyte-like U937 cells. Toxicol Appl Pharmacol 2014;281(1):125. 9. Anderson H, Toms AP, Cahir JG, et al. Grading the severity of soft tissue changes associated with metal-on-metal hip replacements: reliability of an MR grading system. Skelet Radiol 2011;40(3):303. 10. van der Weegen W, Brakel K, Horn RJ, et al. Comparison of different pseudotumor grading systems in a single cohort of metal-on-metal hip arthroplasty patients. Skelet Radiol 2014;43(2):149. 11. Potter HG, Nestor BJ, Sofka CM, et al. Magnetic resonance imaging after total hip arthroplasty: evaluation of periprosthetic soft tissue. J Bone Joint Surg Am 1947;86A(9):2004.
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12. Nawabi DH, Hayter CL, Su EP, et al. Magnetic resonance imaging findings in symptomatic versus asymptomatic subjects following metal-on-metal hip resurfacing arthroplasty. J Bone Joint Surg Am 2013;95(10):895. 13. Nawabi DH, Gold S, Lyman S, et al. MRI predicts ALVAL and tissue damage in metalon-metal hip arthroplasty. Clin Orthop Relat Res 2014;472(2):471. 14. Hayter CL, Gold SL, Koff MF, et al. MRI findings in painful metal-on-metal hip arthroplasty. AJR Am J Roentgenol 2012;199(4):884. 15. Fox CM, Bergin KM, Kelly GE, et al. MRI findings following metal on metal hip arthroplasty and their relationship with metal ion levels and acetabular inclination angles. J Arthroplast 2014;29(8):1647. 16. Chang EY, McAnally JL, Van Horne JR, et al. Metal-on-metal total hip arthroplasty: do symptoms correlate with MR imaging findings? Radiology 2012;265(3):848. 17. Wynn-Jones H, Macnair R, Wimhurst J, et al. Silent soft tissue pathology is common with a modern metal-on-metal hip arthroplasty. Acta Orthop 2011;82(3):301. 18. Van Der Straeten C, Grammatopoulos G, Gill HS, et al. The 2012 Otto Aufranc Award: the interpretation of metal ion levels in unilateral and bilateral hip resurfacing. Clin Orthop Relat Res 2013;471(2):377. 19. van der Weegen W, Smolders JM, Sijbesma T, et al. High incidence of pseudotumours after hip resurfacing even in low risk patients; results from an intensified MRI screening protocol. Hip Int 2013;23(3):243. 20. Choi SJ, Koch KM, Hargreaves BA, et al. Metal artifact reduction with MAVRIC SL at 3-T MRI in patients with hip arthroplasty. AJR Am J Roentgenol 2015;204(1):140. 21. Hayter CL, Koff MF, Shah P, et al. MRI after arthroplasty: comparison of MAVRIC and conventional fast spin-echo techniques. AJR Am J Roentgenol 2011;197(3): W405. 22. Hart AJ, Sabah SA, Sampson B, et al. Surveillance of patients with metal-on-metal hip resurfacing and total hip prostheses: a prospective cohort study to investigate the relationship between blood metal ion levels and implant failure. J Bone Joint Surg Am 2014;96(13):1091. 23. Reito A, Moilanen T, Puolakka T, et al. Repeated metal ion measurements in patients with high risk metal-on-metal hip replacement. Int Orthop 2014;38(7): 1353. 24. Sethi RK, Neavyn MJ, Rubash HE, et al. Macrophage response to cross-linked and conventional UHMWPE. Biomaterials 2003;24(15):2561. 25. Hallab N, Merritt K, Jacobs JJ. Metal sensitivity in patients with orthopaedic implants. J Bone Joint Surg Am 2001;83-A(3):428. 26. Kwon YM, Lombardi AV, Jacobs JJ, et al. Risk stratification algorithm for management of patients with metal-on-metal hip arthroplasty: consensus statement of the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and the Hip Society. J Bone Joint Surg Am 2014;96(1):e4. 27. Reito A, Elo P, Puolakka T, et al. Repeated magnetic resonance imaging in 154 hips with large-diameter metal-on-metal hip replacement. Acta Orthop 2014;1. 28. van der Weegen W, Brakel K, Horn RJ, et al. Asymptomatic pseudotumours after metal-on-metal hip resurfacing show little change within one year. Bone Joint J 2013;95-B(12):1626. 29. Almousa SA, Greidanus NV, Masri BA, et al. The natural history of inflammatory pseudotumors in asymptomatic patients after metal-on-metal hip arthroplasty. Clin Orthop Relat Res 2013;471(12):3814. 30. Hasegawa M, Miyamoto N, Miyazaki S, et al. Longitudinal magnetic resonance imaging of pseudotumors following metal-on-metal total hip arthroplasty. J Arthroplast 2014;29(12):2236. 31. Thomas MS, Wimhurst JA, Nolan JF, et al. Imaging metal-on-metal hip replacements: the Norwich experience. HSS J 2013;9(3):247.
Please cite this article as: Madanat R, et al, The Symmetry of Adverse Local Tissue Reactions in Patients with Bilateral Simultaneous and Sequential ASR Hip Replacement, J Arthroplasty (2015), http://dx.doi.org/10.1016/j.arth.2015.04.036
