Nationwide investigation into adverse tissue reactions to metal debris after metal-on-metal total hip arthroplasty in Japan

Sugano, Nobuhiko; Iida, Hiroya; Akiyama, Haruhiko; Takatori, Yoshio; Nagoya, Satoshi; Hasegawa, Masahiro; Kabata, Tamon; Hachiya, Yudo; Yasunaga, Yuji

doi:10.1007/s00776-013-0490-2

Cited by 17 publications

(13 citation statements)

References 32 publications

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“…Our results and those of other published studies demonstrate that ARMD does occur with small-diameter heads in MoM THA [5,8,12,19,20,39,44,48]. Unlike large-diameter MoM THA, in which aseptic loosening and early failure of ingrowth appear to be the main failure modes with ARMD appearing in the early to midterm, MoM THA with a titanium shell and cobalt-chromium insert had very low rates of aseptic loosening.…”

Section: Discussionsupporting

confidence: 62%

“…In comparison, in the current study the frequency of ARMD was 5% (14 of 300) at a mean followup of 10 years (range, 2-19 years), but frequency of revision for aseptic loosening was much lower at 1% (four of 300). In an investigation into frequency of ARMD after MoM THA performed from 2000 to 2011 in Japan that involved questionnaires returned from 82 hospitals, ARMD was reported in 1.2% of THAs (160 of 12,961) [48]. The frequency in 28-mm Metasul bearings was 0.5% (seven of 1535).…”

Section: Discussionmentioning

confidence: 99%

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Adverse Reactions to Metal on Metal Are Not Exclusive to Large Heads in Total Hip Arthroplasty

Lombardi

Berend

Adams

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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Background There is some suggestion that smaller diameter heads in metal-on-metal total hip arthroplasty (MoM THA) may be less prone to the adverse reactions to metal debris (ARMD) seen with large-diameter heads. Questions/purposes We reviewed our population of patients with small head (B 32 mm) MoM THA to determine (1) the frequency of ARMD; (2) potential risk factors for ARMD in this population; and (3) the etiology of revision and Kaplan-Meier survivorship with revision for all causes. Methods Small-diameter head MoM devices were used in 9% (347 of 3753) of primary THAs during the study period (January 1996 to March 2005. We generally used these implants in younger, more active, higher-demand patients. Three hundred hips (258 patients) had MoM THA using a titanium modular acetabular component with a cobaltchromium tapered insert and were available for review with minimum 2-year followup (mean, 10 years; range, 2-19 years). Complete followup was available in 86% of hips (300 of 347). Clinical records and radiographs were reviewed to determine the frequency and etiology of revision. Kaplan-Meier survivorship analysis was performed. Results ARMD frequency was 5% (14 of 300 hips) and represented 70% (14 of 20) of revisions performed. Using multivariate analysis, no variable tested, including height, weight, body mass index, age, cup diameter, cup angle, use of screws, stem diameter, stem type, head diameter, preoperative clinical score, diagnosis, activity level, or sex, was significant as a risk factor for revision. Twenty hips have been revised: two for infection, four for aseptic loosening, and 14 for ARMD. Kaplan-Meier analysis The institution of one or more of the authors (AVL, KRB, JBA, KLS) has received funding from Biomet, Inc (Warsaw, IN, USA), Pacira Pharmaceuticals Inc (Parsippany, NJ, USA), and Orthosensor (Dania Beach, FL, USA). One of the authors certifies that he (AVL) has or may receive payments or benefits, during the study period, an amount of more than USD 1,000,001 from Biomet, Inc, an amount of USD 10,000 to USD 100,000 from Innomed, Inc (Savannah, GA, USA), an amount of less than USD 10,000 from Pacira Pharmaceuticals Inc, and an amount of less than USD 10,000 from Orthosensor. One of the authors certifies that he (KRB) has or may receive payments or benefits, during the study period, an amount of more than USD 1,000,001 from Biomet, Inc. revealed survival free of component revision for all causes was 95% at 10 years (95% confidence interval [CI], 91%-97%), 92% at 15 years (95% CI, 87%-95%), and 72% at 19 years (95% CI, 43%-90%), and survival free of component revision for aseptic causes was 96% at 10 years (95% CI, 92%-98%), 92% at 15 years (95% CI, 88%-95%), and 73% at 19 years (95%

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Section: Discussionsupporting

confidence: 62%

Section: Discussionmentioning

confidence: 99%

Adverse Reactions to Metal on Metal Are Not Exclusive to Large Heads in Total Hip Arthroplasty

Lombardi

Berend

Adams

et al. 2016

Clinical Orthopaedics &Amp; Related Research

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“…There is considerable variation in published reports as to the risk of revision and ARMD incidence between different largediameter MoM THA devices as well as for the devices used in the current study (Table 3) [9,16,26,29,32,34,44,46,47,60]. Several studies have reported good survival and a low incidence of ARMD with the devices we used in this report [12,29,32,34,44,47,51,57,60,61]. Two concerning studies involving the Magnum TM device in largediameter MoM THA have reported a high incidence of ARMD with pseudotumor formation when a comprehensive screening protocol was implemented [9,46] incidence of ARMD asymptomatic patients, raising concern that the need for routine cross-sectional imaging for all asymptomatic patients with MoM implants warrants further study [15].…”

Section: Discussionmentioning

confidence: 89%

Large-diameter Metal-on-metal Total Hip Arthroplasty: Dislocation Infrequent but Survivorship Poor

Lombardi

Berend

Morris

et al. 2015

Clinical Orthopaedics &Amp; Related Research

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“…ARMD is commonly associated with mechanically assisted metal corrosion at the head–neck taper interface as well as articulation wear 12 , 13 , 14 . Several studies have identified the use of large heads (≥36 mm) as a significant risk factor for ARMD in MoM THA because of large frictional torque at the modular head–neck interfaces 15 , 16 , 17 . ARMD is often asymptomatic, and its careful screening is hardly performed before clear symptoms appear.…”

Section: Introductionmentioning

confidence: 99%

Adverse Tissue Reactions and Metal Ion Behavior After Small‐Head Metasul Hip Arthroplasty: A Long‐Term Follow‐Up Study

Ishida

Tateiwa

Takahashi

et al. 2021

Orthopaedic Surgery

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Objective To investigate the long‐term survivorship, incidence of adverse reactions to metal debris (ARMD), and metal ion behavior in patients who underwent small‐head Metasul metal‐on‐metal (MoM) total hip arthroplasty (THA). Methods Between February 1998 and September 2003, a retrospective study was performed on 43 consecutive patients (43 hips) who underwent unilateral cementless Metasul MoM THAs at our institution. Of them, 35 patients (nine males and 26 females) who were available for follow‐up more than 15 years after THA were enrolled in this study and underwent metal artifact reduction sequence magnetic resonance imaging (MARS‐MRI) to identify ARMD. The mean age at surgery of the patients was 59.7 years old (range, 31–83). Clinical and radiographic outcomes were evaluated retrospectively. Clinical examinations were conducted using the Harris Hip Score (HHS). Serum cobalt (Co) and chromium (Cr) ion levels and Co/Cr ratio were assessed at different postoperative periods of <5, 5–10, 11–14, and ≥15 years. Results The mean follow‐up period for the 35 patients included was 18.1 years (range, 15–22). The mean HHS significantly improved from 44.6 ± 11.3 points preoperatively to 89.4 ± 7.9 points at the final follow‐up (P < 0.0001). ARMD was found in 20% of the patients using MARS‐MRI. No signs of stem loosening were found clinically or radiographically, whereas cup loosening and ARMD were observed in three patients (9%), for whom revision THAs were performed. The Kaplan–Meier survival rates with revision for any reason as the endpoint were 90.9% at 5 years, 84.8% at 10 years, 84.8% at 15 years (95% CI, 67.1–93.6), and 70.3% at 20 years (95% CI, 43.6–87.0). The survival rates with revision for ARMD as the endpoint were 100% at 5 years, 96.6% at 10 years, 96.6% at 15 years (95% CI, 77.2–99.7), and 80.1% at 20 years (95% CI, 45.3–95.2). Serum Co ion level peaked at 5–10 years after THA, which was significantly higher than that <5 years; however, it decreased to the initial level after 15 years. In contrast, serum Cr ion level significantly increased at 5–10 years and then remained almost constant. Significant differences in Cr ion levels (1.0 vs 2.0 μg/L, P = 0.024) and Co/Cr ratio (1.3 vs 0.9, P = 0.037) were found between non‐ARMD and ARMD patients at >11 years postoperatively. Conclusion Our results suggest that increased Cr ion levels and decreased Co/Cr ratio may be signs of ARMD in patients who underwent small‐head Metasul MoM THA.

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Nationwide investigation into adverse tissue reactions to metal debris after metal-on-metal total hip arthroplasty in Japan

Cited by 17 publications

References 32 publications

Adverse Reactions to Metal on Metal Are Not Exclusive to Large Heads in Total Hip Arthroplasty

Adverse Reactions to Metal on Metal Are Not Exclusive to Large Heads in Total Hip Arthroplasty

Large-diameter Metal-on-metal Total Hip Arthroplasty: Dislocation Infrequent but Survivorship Poor

Adverse Tissue Reactions and Metal Ion Behavior After Small‐Head Metasul Hip Arthroplasty: A Long‐Term Follow‐Up Study

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