Abstract
Background
Metallosis is a well-described complication of total hip arthroplasty (THA); however, its impact on periprosthetic joint infection (PJI) diagnosis and treatment remains unknown. We assessed whether coexisting metallosis at the time of revision THA is associated with delayed diagnosis and poorer PJI treatment outcomes.
Methods
We retrospectively reviewed patients undergoing revision THA due to chronic and acute hematogenous PJI with coexisting metallosis (metallosis and PJI group). A matched cohort of patients with chronic and acute hematogenous PJI without metallosis was established (control group). The 2018 International Consensus Meeting criteria were used to define PJI. Metallosis was diagnosed based on the intraoperative findings or serum chromium/cobalt levels. The primary outcomes were culture positivity and survival free of reoperation or revision. Thirteen and 42 patients were included in the metallosis and PJI and the control groups, respectively.
Results
The initial set of cultures was negative in 38% of patients in the metallosis and PJI group, compared to only 12% in the control group (P = .03). Time elapsed between presentation of symptoms and first positive culture was significantly longer in the metallosis and PJI group compared to the control (14.5 vs 0 days, P < .001). The revision rate was 46% in the metallosis and PJI group and 24% in the control group (P = .12). Revision-free survival in patients treated with debridement, antibiotics, and implant retention was 28% in the metallosis and PJI group and 79.7% in the control group, (P = .21).
Conclusions
Metallosis may increase the likelihood of initial false negative culture results and delay PJI diagnosis in patients undergoing revision THA.
Keywords: Periprosthetic joint infection, Revision arthroplasty, Total hip arthroplasty, Metallosis
Introduction
The collection of metallic particulate debris in the joint, synovial fluid and surrounding soft tissues following total hip arthroplasty (THA) is known as metallosis [1,2]. Metallosis can result in the formation of adverse local tissue reactions as a result of an extensive inflammatory soft tissue response [[3], [4], [5], [6]]. Intra-articular metal ions can be generated from a variety of metal interfaces depending on the type of implant and bearing surface [4]. While metallosis is most often associated with metal-on-metal (MoM) implants [7,8], it can also arise on ceramic-on-metal implants, or implants with modular femoral components [[9], [10], [11]]. Adverse local tissue reactions have been reported in dual taper stems secondary to corrosion at the modular neck-body junction [10]. Furthermore, the advent of dual mobility constructs introduces another potential source of metal ions due to backside wear between the metal acetabular component and metal liner [12].
The bactericidal properties of certain metal ions are well-documented, with silver ions used in modern dressings to prevent infection in surgical wounds [13,14]. In arthroplasty, however, metallosis has been reported to complicate the diagnosis of periprosthetic joint infections (PJIs) by causing false positive results in synovial fluid alpha-defensin tests [[15], [16], [17]]. While the underlying mechanism is not fully understood, metal particles and ions can spread throughout the body and alter the immune response, potentially impairing the host's ability to combat infections [[18], [19], [20]]. To the best of our knowledge, the impact of metallosis on diagnosis and treatment of PJI in patients undergoing septic revisions remains unknown.
Therefore, our study aimed to assess whether coexisting metallosis at the time of revision THA is associated with delayed diagnosis of PJI and poorer treatment outcomes compared to patients without metallosis. We hypothesize that coexisting metallosis and PJI will result in delayed culture growth and lower rates of infection eradication compared to patients with only PJI.
Material and methods
Study design and setting
Institutional review board approval was obtained prior to the start of the study. We conducted a retrospective review from a prospectively collected arthroplasty registry. This registry includes all total joint arthroplasty procedures performed at 2 tertiary care academic medical centers in the northeastern United States.
Inclusion criteria
We identified patients undergoing revision THA between January 2009 and December 2019 using the Current Procedural Terminology codes 27134, 27137 and 27138. Inclusion criteria were (1) chronic or acute hematogenous PJI as the indication for revision THA and (2) coexisting metallosis at the time of revision. Diagnosis of PJI was established using the 2018 International Consensus Meeting (ICM) criteria [21]. Both major and minor criteria were used for diagnosis and, for all cases, consensus between an infectious disease specialist and an orthopedic surgeon was required. PJIs occurring more than 3 months after index surgery were defined as chronic [[21], [22], [23]]. Metallosis was diagnosed based on the gross intraoperative findings documented in the surgeon's operative report including metallic/black staining of the periarticular soft tissues, visible corrosion debris at modular interfaces including the trunnion, and/or elevated serum cobalt and chromium levels. This group of patients with coexisting PJI and metallosis was classified as the metallosis and PJI group. We additionally identified a control group, consisting of patients undergoing revision THA due to chronic or acute hematogenous PJI and no documented evidence of metallosis at the time of revision. Thirteen patients were identified in the metallosis and PJI and matched to 42 control patients with a 1:3 ratio of study to control patients, matched by American Society of Anesthesiologists (ASA) class, age, and gender.
Study variables
Demographic and clinical variables collected included age, sex, race, ASA physical status classification, presence of clinical symptoms or sinus tract at the time of revision, preoperative laboratory tests, and follow-up time in months. Preoperative tests included serum inflammatory markers (C-reactive protein [mg/L] and erythrocyte sedimentation rate [mm/h]) and synovial fluid tests (white blood cell count [WBC count, cells/μL] and polymorphonuclear leukocyte percentage). Threshold values for each laboratory parameters were based on the 2013 and 2018 ICM criteria [21,23]. Microbiological data were based on intraoperative samples and when available, preoperative joint aspiration. For each case, 3 to 8 intraoperative samples were collected, including soft tissue and bone specimens, as well as samples from the tibial and femoral canals in 2-stage revisions. These were sent for aerobic, anaerobic, fungal, and mycobacterial cultures. At our institution, cultures are routinely performed on solid media, including blood, chocolate, and MacConkey agar plates, as well as thioglycolate broth. Aerobic and anaerobic cultures are incubated for 14 days, while fungal and mycobacterial cultures are held for 28 and 56 days, respectively.
The primary outcomes of the study were (1) culture positivity and (2) survival free of reoperation or revision due to infection recurrence. A reoperation was defined as any surgery with complete implant retention, while a revision involved the removal or exchange of fixed or modular components. All revisions by definition were reoperations, but not all reoperations were revisions. Treatment success was defined as a composite of no further surgical treatment for PJI, symptom remission, and normalization of laboratory parameters. The 2 surgical strategies performed for PJI were debridement, antibiotics, and implant retention (DAIR) and 2-stage revision. DAIR was performed if the infection was deemed to be acute hematogenous spread; 2-stage revision was performed for chronic infections [24]. All DAIR procedures entailed exchange of the head and liner.
Patient characteristics
Thirteen and 42 patients were included in the metallosis and PJI and the control groups, respectively. Median age was 66 for the metallosis and PJI group, and 68 for the control group (Table 1). There were no differences in sex distribution (P = .81) or ASA class (P = .14) between groups. The majority of patients in both metallosis and PJI and control group displayed clinical symptoms (77% and 93%, respectively). There was no difference in median follow-up between the metallosis and PJI and the control groups (9 vs 13 months, P = .34).
Table 1.
Baseline characteristics and preoperative laboratory parameters.
| Variable | All (N = 55) | Metallosisa PJI (N = 13) | Controls (N = 42) | P value |
|---|---|---|---|---|
| Agea | 67 (57-71) | 66 (56-72) | 68 (58-70) | .81 |
| Female sex | 23 (42%) | 6 (46%) | 17 (40%) | .72 |
| Race | .81 | |||
| White | 52 (95%) | 13 (100%) | 39 (93%) | |
| Black | 1 (2%) | 0 (0%) | 1 (2%) | |
| Asian | 1 (2%) | 0 (0%) | 1 (2%) | |
| Hispanic | 1 (2%) | 0 (0%) | 1 (2%) | |
| ASA class | .14 | |||
| 1 | 1 (2%) | 1 (8%) | 0 (0%) | |
| 2 | 13 (24%) | 4 (31%) | 9 (21%) | |
| 3 | 41 (75%) | 8 (62%) | 33 (79%) | |
| Clinical symptoms | 49 (89%) | 10 (77%) | 39 (93%) | .11 |
| Sinus tract | 3 (5%) | 1 (8%) | 2 (5%) | .68 |
| CRP (mg/dL)a | 62 (23-150) | 113 (25-164) | 54 (22-146) | .66 |
| >10 mg/dLb | 46 (90%) | 11 (92%) | 35 (90%) | .84 |
| ESR (mm/h)a | 55 (33-87) | 56 (33-79) | 52 (33-97) | .74 |
| >30 mm/hb | 37 (79%) | 6 (86%) | 31 (78%) | .62 |
| WBC count (cells/μL)a | 20,158 (8694-35,500) | 14,583 (10-35,089) | 20,316 (9813-60,000) | .48 |
| >3000 cells/μLb | 27 (79%) | 5 (71%) | 22 (81%) | .56 |
| PMN%a | 91 (84-96) | 86 (60-95) | 91 (85-96) | .36 |
| >80%b | 28 (85%) | 4 (67%) | 24 (89%) | .17 |
| Follow-up (mos)a | 11 (4, 31) | 9 (2, 26) | 13 (5, 31) | .34 |
CRP, C-reactive protein; PMN%, polymorphonuclear leukocyte percentage; ESR, erythrocyte sedimentation rate.
Values displayed in these rows refer to the median and IQR.
Thresholds established by the 2013 and 2018 ICM criteria for diagnosing chronic PJIs.
Elevated C-reactive protein (>10 mg/L) and erythrocyte sedimentation rate (>30 mm/h) were seen in 92% and 86% of patients in the metallosis and PJI group, and 90% and 78% in the control group, respectively (Table 1). We did not see any differences in the proportion of patients with elevated WBC count (>3000 cells/μL) and polymorphonuclear leukocyte percentage (>80%) between groups.
Gram-positive microorganisms were isolated in 88% and 86% of patients in the metallosis and PJI and control groups, respectively (Table 2). Coagulase-negative Staphylococci were isolated in 50% of patients with metallosis and PJI, and Staphylococcus aureus in 53% of control patients. Fungal microorganisms and Morganella morganii were more common in the metallosis and PJI group (P = .03 for both). The proportion of polymicrobial infections was 38% in the metallosis and PJI group, and 16% in the control group (P = .17).
Table 2.
Culture growth and microbiology.
| Variable | All (N = 55) | Metallosisa PJI (N = 13) | Controls (N = 42) | P value |
|---|---|---|---|---|
| Culture growth | .03 | |||
| No | 10 (18%) | 5 (38%) | 5 (12%) | |
| Yes | 45 (82%) | 8 (62%) | 37 (88%) | |
| Gram-positive | 39 (87%) | 7 (88%) | 32 (86%) | .94 |
| Staphylococcus aureus | 22 (50%) | 3 (38%) | 19 (53%) | .43 |
| Coagulase-negative Staphylococcus | 12 (27%) | 4 (50%) | 8 (22%) | .11 |
| Streptococcus spp. | 8 (18%) | 2 (25%) | 6 (17%) | .58 |
| Gram-negative | 10 (22%) | 1 (13%) | 9 (24%) | .47 |
| Pseudomonas aeruginosa | 4 (9%) | 0 (0%) | 4 (11%) | .33 |
| Salmonella spp. | 2 (4%) | 0 (0%) | 2 (5%) | .50 |
| Morganella morganii | 1 (2%) | 1 (13%) | 0 (0%) | .03 |
| Escherichia coli | 1 (2%) | 0 (0%) | 1 (3%) | .64 |
| Fungal | 1 (2%) | 1 (13%) | 0 (0%) | .03 |
| Polymicrobial | 9 (20%) | 3 (38%) | 6 (16%) | .17 |
Bold represents statistical significance.
Values displayed in these rows refer to the median and IQR.
Cobalt and chromium serum levels were also evaluated in 9 patients in the metallosis and PJI group. Median cobalt was 9.6 nmol/L (interquartile range [IQR], 1.6-6.6) and median chromium was 1.7 (IQR, 0.9-2.5). In the 9 patients in whom preoperative serum metal ions were measured, a manual cell count of the synovial fluid aspirate was also performed due to the preoperative suspicion for metallosis. In all other patients, only an automated cell count was performed.
Data analysis
To reduce the effect of potential confounding between the metallosis and PJI and control groups, patients were matched using propensity scores. Propensity score matching was conducted using a 3-to-1 nearest neighbor matching without replacement and a caliper fixed at 0.1. The propensity scores were calculated using a logit model including the following variables: age, sex, and ASA class (Fig. 1).
Figure 1.
Propensity scores (a) before, and (b) after matching.
Demographic, clinical, and treatment variables were reported using descriptive statistics. Normality of data distribution was evaluated using the Shapiro–Wilk test. Continuous variables were displayed using median and IQRs, while categorical variables were displayed as proportions. The Mann–Whitney U-test (nonparametric) was used to compare continuous variables between groups; for categorical variables, the Chi-square test was used.
Survival free of revision or reoperation was evaluated using the Kaplan–Meier method. One- and 2-year reoperation- and revision-free survival were calculated. Differences in survival between groups at such time points were compared using the Log-rank test. A post hoc power analysis using the method described by Freedman et al. [25] was conducted calculate the effect size using Log-rank tests. Using a significance level of 0.05 (α = 0.05), the comparison of reoperation-free survival at 2 years after DAIR between the metallosis and PJI group and the control group yielded a power of 60.3%. To achieve 80% statistical power (β = 0.2) and effectively reject the null hypothesis, a minimum sample size of 26 patients per group, totaling 52 patients, would have been required. Our sample was smaller than the calculated sample and, therefore, larger studies are necessary to further evaluate the impact of coexisting metallosis and PJI on postoperative surgical outcomes
A P value <.05 was considered statistically significant. All statistical analyses were conducted using Stata (StataCorp, College Station, Texas).
Results
The initial set of preoperative cultures was negative in 38% of patients in the metallosis and PJI group, compared to only 12% in the control group (P = .03). All patients with negative cultures had a diagnosis of PJI based on the presence of an additional major criteria (draining sinus) or minor criteria. (Table 2)
Reoperation for PJI recurrence occurred in 46% of patients in the metallosis and PJI group, and 36% in the control group (P = .50) (Table 3). Revision rates in the metallosis and PJI and the control group were 46% and 24%, respectively (P = .12). There were no differences in the time to revision and the total reoperation count between groups.
Table 3.
Treatment and postoperative outcomes.
| Variable | All (N = 55) | Metallosisa PJI (N = 13) | Controls (N = 42) | P value |
|---|---|---|---|---|
| PJI index surgery | .10 | |||
| DAIR | 27 (49%) | 9 (69%) | 18 (43%) | |
| Two-stage revision | 28 (51%) | 4 (31%) | 24 (57%) | |
| Reoperation | .50 | |||
| No | 34 (62%) | 7 (54%) | 27 (64%) | |
| Yes | 21 (38%) | 6 (46%) | 15 (36%) | |
| Revision | .12 | |||
| No | 39 (71%) | 7 (54%) | 32 (76%) | |
| Yes | 16 (29%) | 6 (46%) | 10 (24%) | |
| Time to revision (months)a | 5 (1, 11) | 6 (1, 6) | 4 (1, 11) | .99 |
| Total reoperations (n)a | 1 (1, 3) | 1 (1, 3) | 1 (1, 3) | .79 |
Values displayed in these rows refer to the median and IQR.
Reoperation-free survival in patients treated with DAIR was 68.6% in the control group, and 28% in the metallosis and PJI group (P = .56) (Fig. 2a). Likewise, revision-free survival after DAIR treatment was 79.7% and 28% in the control group and metallosis and PJI groups, respectively (P = .21) (Fig. 2b). We saw no differences in revision free of reoperation or revision at 2 years in patients treated with two-stage revision (Fig. 3). The exact survival values at 1 and 2 years for each group are displayed on Table 4.
Figure 2.
Survival free of (a) reoperation, and (b) revision for patients treated with DAIR.
Figure 3.
Survival free of (a) reoperation, and (b) revision for patients treated with 2-stage revision.
Table 4.
Survival free of reoperation or revision by group.
| Variable | Survival free of reoperation |
Survival free of revision |
||
|---|---|---|---|---|
| 1 y | 2 y | 1 y | 2 y | |
| DAIR | ||||
| Controls | 68.6 (39.1-85.9) | 68.6 (39.1-85.9) | 79.7 (48-93.2) | 79.7 (48-93.2) |
| Metallosis + PJI | 56 (14.5-84) | 28 (1.4-68.7) | 56 (14.5-84) | 28 (1.4-68.7) |
| P value | 0.87 | 0.56 | 0.40 | 0.21 |
| Two-stage | ||||
| Controls | 65.9 (40.7-82.4) | 48.8 (22.2-71.1) | 75.7 (50.4-89.3) | 66.2 (37-84.3) |
| Metallosis + PJI | 50 (5.8-84.5) | 50 (5.8-84.5) | 50 (5.8-84.5) | 50 (5.8-84.5) |
| P value | 0.53 | 0.72 | 0.29 | 0.37 |
Values displayed in all rows refer to the survival at that time point and 95% confidence interval in parenthesis.
Discussion
Although the use of MoM implants in THA has significantly decreased over the past 15 years, it is estimated that >1 million MoM articulations have been implanted globally since 1996 [2,26]. Moreover, the advent of modular stems and dual taper stems has raised new concerns for metallosis due to corrosion at the head–neck or neck–body junction [27,28]. Despite the growing burden of PJIs in the United States, which are expected to cost $1.85 billion by 2030 [29], the relationship between PJI and metallosis has not been evaluated. Our study findings revealed that coexistence of metallosis and PJI after THA was associated with a higher rate of initial negative cultures and a longer time to positive culture. To our knowledge, this is the first study to investigate the impact of metallosis and PJI on the diagnosis and treatment of PJIs.
In our study, the metallosis and PJI group had higher negative culture rates on initial testing (38% vs 12%). Due to its devastating consequences, prompt diagnosis of PJI using the 2013 and 2015 ICM criteria is critical [21,23]. However, only 2 studies have investigated how metallosis affects serum inflammatory biomarkers used for diagnosing PJIs [15,16]. Bonanzinga et al. found metallosis in 2 of 4 patients with false positive alpha-defensin immunoassay results [16], while Dermengian et al reported a 16% false positive rate for PJIs in patients with metallosis [15]. Notably, neither study included a group with both metallosis and PJI, limiting the applicability of their findings to patients with both conditions. We attribute the higher culture negative rate and delayed time to positive culture to the antibacterial properties of cobalt–chromium metal ions. Metallosis can further complicate the diagnosis of infection due to falsely elevated WBC counts in aspirated fluid and tissue when using automated cell counters due to the metallic debris being incorrectly identified as cells, necessitating the use of manual cell count in this setting [30]. In the spine literature, cobalt–chromium alloys have been associated with reduced S. aureus and Cutibacterium acnes proliferation [31] and lower biofilm coverage rates [32] compared to titanium. Thus, orthopedic surgeons should be particularly cautious with patients suspected of metallosis, as it can affect accuracy of PJI diagnostic tests like alpha-defensin and intraoperative cultures.
Our study found no significant difference in reoperation- and revision-free survival between groups at 1 and 2 years postoperatively. The 28% 2-year revision-free survival in the metallosis and PJI group aligns with the 36.4% reported by Rahardja et al in a recent multicentric study [33]. While we expected that metallosis and PJI would lead to lower infection control rates due to delayed diagnosis, the lack of statistical significance may be attributed to the small sample size.
Our study displayed several limitations. First, the retrospective design means we can only identify associations, not causal relationships. Second, although this multi-institutional study is the first to focus on the metallosis and PJI population, the sample size remains small. Insufficient statistical power may partially explain the lack of significance in our survival analysis comparing metallosis and PJI patients to controls. Third, the high heterogeneity within our study population introduces potential confounding, which may affect the validity of our findings. Although we performed a propensity score matching analysis to control for potential confounders, other variables not captured in our study may still differ between groups. Fourth, the choice between DAIR and 2-stage procedures for PJI was highly selective, so results from one approach should not be directly compared to the other. To address this, we stratified our analysis of reoperation- and revision-free survival by type of treatment. Fifth, chromium and cobalt serum levels as well as manual synovial fluid cell counts were not available for all patients; for those patients, diagnosis of metallosis was made based on gross intraoperative findings, which could have led to an underestimation of the true prevalence of metallosis. Patients with a presumptive diagnosis of metallosis, absent gross intraoperative findings, and unavailable serum metal ion levels may have been reclassified as PJI once cultures became positive. Sixth, intraoperative specimens were sent to pathology at the surgeon's discretion to evaluate for metallosis. While this approach may introduce some heterogeneity, all metallosis diagnoses were confirmed through gross pathology or serum metal ion levels. Conversely, patients with only PJI showed no clinical, laboratory, or intraoperative markers indicative of metallosis. Pathology assessment of intraoperative samples is not routinely requested at our institutions, and the likelihood of undetected metallosis in the PJI-only group is exceedingly low. While these factors might affect the internal validity of our findings, this study represents the first and largest cohort to examine microbiology, diagnosis, and outcomes of PJI in the context of metallosis.
Conclusions
The simultaneous occurrence of metallosis and PJI after total joint arthroplasty is rare and often leads to negative cultures and delayed PJI diagnosis. For patients with inconclusive diagnosis of PJI, especially those with multiple minor criteria but lacking major criteria or systemic signs, a multidisciplinary approach with an infectious disease specialist should be considered. Further research with larger sample sizes and stringent criteria is needed to assess how metallosis affects postoperative outcomes. Surgeons should maintain a high index of suspicion for occult PJI in patients with metallosis whose symptoms do not resolve with revision for mechanical failure alone.
CRediT authorship contribution statement
Ayesha Abdeen: Writing – original draft, Data curation, Conceptualization. Nelson Merchan: Writing – original draft, Data curation. Marcos R. Gonzalez: Writing – original draft, Data curation. Joshua B. Davis: Data curation. Jacob Drew: Writing – review & editing, Conceptualization. Rubén Monárrez: Writing – review & editing. Antonia F. Chen: Writing – review & editing. Edward K. Rodriguez: Writing – review & editing, Project administration.
Conflicts of interest
Ayesha Abdeen is a paid consultant for Teledoc, Brixton Biosciences, Depuy, and Smith & Nephew; owns stock or stock options in Brixton Biosciences; has Medical/Orthopaedic publications editorial or is on the governing board of Journal of Arthroplasty; and is a board member or has committee appointments for AAHKS Quality Measures Committee.
Jacob Drew is on the speakers bureau/ receives paid presentations for Depuy/Synthes and receives educational grant for fellowship from Medacta.
Antonia F. Chen receives royalties from Stryker; is a paid consultant for Adaptive Phage Therapeutics, Avanos, BICMD, Convatec, Ethicon, GLG, Guidepoint, Heraeus, IrriMax, Osteal Therapeutics, Peptilogics, Pfizer, Smith & Nephew, Stryker, and TrialSpark; owns stock or stock options in Hyalex, Irrimax, Osteal Therapeutics, Sonoran, and IlluminOss; receives research support as the principal investigator from Adaptive Phage Therapeutics, Elute, Peptilogics, and Sectra; receives royalties, financial, or material support form SLACK Incorporated, UpToDate, Taylor & Francis Group, Journal of Bone and Joint Surgery; has Medical/Orthopaedic publications editorial or is on the governing board of Journal of Arthroplasty, Journal of Bone and Joint Infection, Journal of Bone and Joint Surgery, Arthroplasty Today; and is a board member or has committee appointments for AAOS, AJRR, and AAHKS.
Edward K. Rodriguez receives royalties from Globus; is a paid consultant for Globus and Riverside Partners; and owns stock or stock options at Ortholevo.
The other authors declare no potential conflicts of interest.
For full disclosure statements refer to https://doi.org/10.1016/j.artd.2025.101910.
Appendix A. Supplementary data
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