Pseudotumors and High-Grade Aseptic Lymphocyte-Dominated Vasculitis-Associated Lesions Around Total Knee Replacements Identified at Aseptic Revision Surgery: Findings of a Large-Scale Histologic Review.

BACKGROUND: Aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) development (including pseudotumors) secondary to metal debris generation around total hip arthroplasties is a well-recognized histopathologic phenomenon. Emerging data have highlighted a similar potential concern around TKAs although the body-of-knowledge has largely been limited to individual case reports or small retrospective case series. This study sought to establish the prevalence of pseudotumors or high-grade ALVALs seen at the revision of primary TKAs and to establish the correlation between histologic ALVAL grade and patient-reported functional outcome measures. METHODS: The findings of 321 non-infective (aseptic) patients undergoing unilateral revision knee surgery, at a high-volume tertiary referral center, were reviewed. Each case was independently histologically classified. Complete patient-reported functional outcome measures were available for 134 patients (42%) allowing correlation between functional performance and histopathology results. RESULTS: Five distinct pseudotumors and a further 18 high-grade ALVALs were histologically identified representing 1.6% and 5.6% of the cohort, respectively. When compared by histologic grade, Oxford Knee Score and Western Ontario and McMaster University's Osteoarthritis Index suggested a high correlation between ALVAL grade and functional knee scores. CONCLUSION: These findings suggest a prevalence of pseudotumors or high-grade ALVALs at revision TKA surgery of >7%. This unexpectedly high result may contribute insight into the previously under-appreciated significance of metal debris-related local tissue reactions around TKAs. The findings also demonstrate a strong near-linear inverse relationship between patient-reported clinical knee performance and the underlying histologic grade of local tissue reaction. These results have potential management implications for patients with underperforming TKAs and should prompt consideration of an ALVAL secondary to metallosis in the differential diagnosis. LEVEL OF EVIDENCE: This is a retrospective cohort study with Level III evidence.

Trends in total hip arthroplasty.

This article discusses developments in total hip arthroplasty related to the use of highly cross-linked polyethylene (HXLPE) liner material as the new standard of care for acetabular cup articulation surfaces. The pathologic implications of metal-on-metal hip prostheses in asymptomatic patients also are discussed.

Pseudotumor in metal-on-metal hip arthroplasty: a comparison study of three grading systems with MRI.

OBJECTIVE: Pseudotumors, a well-known complication of metal-on-metal total hip arthroplasty (MoM THA), are well identified on metal artifact-reducing sequences magnetic resonance imaging (MARS-MRI). Several MRI grading systems are described in the orthopedic literature, but their validity is unknown in large clinical studies. Our study was undertaken to describe the classification of pseudotumors in a preselected cohort divided into high- and low-risk patients, using three pseudotumor grading systems applied on MARS-MRI, and to determine the interobserver reliability of the grading systems. PATIENTS AND METHODS: A retrospective study was performed on 377 consecutive patients (240 MRI scans) treated with an M2a-38 and Taperloc stem combination (Biomet, Warsaw, IN, USA). Patients were divided into a high-risk and a low-risk group based on previous published risk factors. Two observers determined the presence of pseudotumors using three different pseudotumor grading systems for classifying MARS-MRI results. RESULTS: The prevalence of pseudotumors as determined with MARS-MRI was 59% in our high-risk group, 0% in the low-risk group and 43% in the control group. Serum cobalt values were increased in the high-risk group. The kappa values of the Anderson, Hauptfleisch and Matthies grading system scores were 0.43, 0.44, and 0.49 respectively. CONCLUSIONS: High-risk patients are at a high risk for pseudotumor development. No pseudotumor development was found in low-risk patients. Interobserver reliability scored best with the Matthies system, but all three grading systems showed only a moderate agreement.

Implant failure in bilateral metal-on-metal hip resurfacing arthroplasties: a clinical and pathological study.

Metal-on-metal hip resurfacing arthroplasties (MoMHRAs) have a high failure rate due to pseudotumour formation. It is not certain whether pseudotumours in bilateral MoMHRAs form on the basis of an adverse reaction to metal debris (ARMD) that is entirely due to a local innate and adaptive immune response to Cobalt-Chrome (Co-Cr) wear particles. To determine if there is a systemic component to ARMD in bilateral MoMHRAs, we examined the histology of ARMD in unilateral and bilateral MoMHRAs revised for pseudotumour and determined whether implant survival differed between these two groups. Periprosthetic tissue specimens from 119 hips revised for pseudotumour were examined. These were derived from 109 patients including 10 patients with bilateral MoMHRAs and 99 with sunilateral MoMHRAs including a cohort of 20 patients with bilateral MoMHRAs that had undergone only one MoMHRA revision for pseudotumour. The mean time to revision for pseudotumour of unilateral and bilateral MoMHRAs was determined. The histology of periprosthetic tissue was examined for evidence of the innate and adaptive immune response and scored semi-quantitatively. There was no significant difference in histological features of the innate / adaptive response between Group 1 bilateral pseudotumours and Group 2 and Group 3 unilateral pseudotumours. Histological features, including ALVAL scores, were similar in the periprosthetic tissues of right and left hips in Group 1 bilateral MoMHRAs. The mean time to first revision for pseudotumour of bilateral MoMHRAs (6.59 years) was not decreased compared with unilateral MoMHRAs (5.66 years) or bilateral MoMHRAs that had only one revision (7.05 years). Right and left hip pseudotumours in bilateral MoMHRAs exhibit similar histological features of the innate and adaptive immune response. Mean implant survival is not decreased in bilateral compared with unilateral MoMHRA cases. The findings suggest that pseudotumour formation is due more to a local than a systemic innate /adaptive immune response to components of metal wear.

Higher Prevalence of Mixed or Solid Pseudotumors in Metal-on-Polyethylene Total Hip Arthroplasty Compared With Metal-on-Metal Total Hip Arthroplasty and Resurfacing Hip Arthroplasty.

BACKGROUND: Pseudotumors are a common finding in metal-on-metal (MoM) total hip arthroplasty (THA) and resurfacing hip arthroplasty (RHA). However, information on pseudotumors in metal-on-polyethylene (MoP) THA is limited. METHODS: One hundred eleven patients with 148 hip articulations-30 MoM THA, 47 MoM RHA, and 71 MoP THA-participated in a cross-sectional study at mean 7.1 (range: 0.2-21.5) years postoperatively. Patients were evaluated with metal artifact reducing sequence magnetic resonance imaging, measurements of metal ions, clinical scores of Harris Hip Score, Oxford Hip Score, the Copenhagen Hip and Groin Outcome Score, and conventional radiographs. RESULTS: Pseudotumors were present in 13 of 30 (43%) MoM THA, 13 of 47 (28%) MoM RHA, and 29 of 71 (41%) MoP THA patients, which was a similar prevalence (P = .10). The prevalence of mixed or solid pseudotumors was significantly higher in patients with MoP THA (n = 10) compared to MoM THA (n = 3) and MoM THA (n = 0), (P = .01). Hips with a mixed or solid pseudotumor had significantly poorer scores of Harris Hip Score (P = .01) and OHS (P = .002) and higher metal ion levels of cobalt (P = .0009) compared to hips without a pseudotumor or with a cystic pseudotumor. CONCLUSION: Pseudotumors have primarily been associated with MoM hip articulations, but we found a similar pseudotumor prevalence in MoP THA, which is the most common bearing worldwide. Mixed or solid pseudotumors were more often seen in MoP THA compared with MoM hip articulations, and patients with a mixed or solid pseudotumor had poorer clinical scores and higher metal ion levels than patients without a pseudotumor or with a cystic pseudotumor.

Epiphyseal pseudotumor of the tibia:an uncommon presentation of osteoarthritis.

Epiphyseal pseudotumor secondary to osteoarthritis are rare in patients under 50 years. We report here the case of a 48-year-old woman who complained of pain in the medial side of the left knee for three years. X-rays of the left knee showed a large lytic lesion containing multiple septae, with sclerotic margins at the upper end of the tibia, associated with knee osteoarthritis. An epiphyseal tumor of the left tibia was suspected. CT scan of the left knee concluded in a giant subchondral cyst secondary to osteoarthritis. Subchondral cysts or geodes are a common finding in patients with knee osteoarthritis. Nevertheless, some unusual aspects of the lesions may lead to diagnosis difficulties.

What Is the Natural History of Asymptomatic Pseudotumors in Metal-on-metal THAs at Mid-term Followup?

BACKGROUND: The risk of early revision because of pseudotumors in patients who have undergone large-head metal-on-metal (MoM) total hip arthroplasty (THA) is well documented. However, the natural history of asymptomatic pseudotumors or of MoM articulations without pseudotumors is less well understood. The aim of our study was to investigate the natural history of primary MoM THA at mid-term followup. QUESTIONS/PURPOSES: The purposes of this study were: (1) Did previously detected pseudotumors persist or worsen in asymptomatic patients at mid-term followup; and if so, did any of them require revision THA? (2) Did new pseudotumors form in asymptomatic patients at mid-term followup? (3) What happened to serum trace metal ions at mid-term followup? (4) Were postoperative patient-reported outcome measures (PROMs) maintained at mid-term followup? METHODS: Seventy-one patients who underwent a MoM THA using a Metasul LDH implant with a Durom acetabular cup and an M/L Taper stem between September 2005 and October 2008 were reviewed. All patients for this study were part of two previously published studies from our early followup. Data from the previous studies were used for comparison only. Two of the 71 patients (2.8%) were lost to followup. The mean age at operation was 56 years (range, 34-68 years). There were 24 female patients. All patients had serum trace metal ions testing, ultrasound imaging, and PROMs at a mean 3.5 years (early followup) after the index operation (range, 3-5 years) and delayed followup at a mean 7 years (range, 6.5-9 years). The indication to undertake revision THA was based on clinical evaluation and not solely on the investigation results. RESULTS: Twenty-three of 71 patients (32%) had a positive ultrasound scan for pseudotumor at early followup. Of these, eight patients underwent revision THA (11% of MoM THA or 35% of patients with an early positive ultrasound scan). The mean time between positive ultrasound scan and revision surgery was 13 months (range, 5-22 months). Of the remaining 15 patients with pseudotumor noted on early ultrasound, 12 had persistent pseudotumor, two resolved, and one was lost to followup. Six patients (13%) with a normal ultrasound scan at early followup showed new ultrasound findings at delayed followup. Of these, four (8%) were conclusively diagnosed as pseudotumor and one was revised. Serum trace metal ion increased at mid-term followup in the seven cases that showed an increase in volume of pseudotumor. Of the five patients in whom the volume of pseudotumor decreased on ultrasound at mid-term followup, three showed a decrease in serum trace ions levels, whereas two showed an increase. New-onset pseudotumors at mid-term followup was associated with an increase in serum trace metal ions at mid-term followup only in two of six cases. PROMs at mid-term followup of patients in this study remain high. CONCLUSIONS: At mid-term followup, approximately 35% of patients who develop an early pseudotumor undergo revision arthroplasty, whereas the remaining are asymptomatic. The incidence of new-onset ultrasound findings suggestive of pseudotumors at mid- to long-term followup is approximately 8% and these require continued surveillance. LEVEL OF EVIDENCE: Level II, prognostic study.

Poor Survivorship and Frequent Complications at a Median of 10 Years After Metal-on-Metal Hip Resurfacing Revision.

BACKGROUND: High short-term failure rates have been reported for several metal-on-metal hip resurfacing (MoMHR) designs. Early observations suggested that MoMHRs revised to total hip arthroplasties (THAs) for pseudotumor had more major complications and inferior patient-reported outcomes compared with other revision indications. However, little is known about implant survivorship and patient-reported outcomes at more than 5 years after MoMHR revision. QUESTIONS/PURPOSES: (1) What are the implant survivorship, proportion of complications and abnormal radiological findings, and patient-reported outcomes at a median of 10 years after MoMHR revision surgery? (2) Are survivorship, complications, and patient-reported outcomes influenced by revision indication? (3) Do any other factors predict survivorship, complications, and patient-reported outcomes? METHODS: Between 1999 and 2008, 53 MoMHR revision procedures in 51 patients (mean age, 55 years; 62% female) were performed at one center and were all included in this retrospective study. Two patients (4%) were lost to followup and two patients (4%) died before a minimum followup of 7 years (median, 10.3 years; range 7-15 years). Revision indications included pseudotumor (n = 16), femoral neck fracture (n = 21), and other causes (n = 16). In most cases (62%, n = 33) both components were revised to a non-MoM bearing THA with the remainder (38%, n = 20: fracture, loosening, or head collapse) undergoing femoral-only revision to a large-diameter MoM THA. Postrevision complications, rerevision, Oxford Hip Score (OHS), and UCLA score were determined using both a longitudinally maintained institutional database and postal questionnaire. Implant survivorship was assessed using the Kaplan-Meier method (endpoint was rerevision surgery). Radiographs at latest followup were systematically assessed for any signs of failure (loosening, migration, osteolysis) by one observer blinded to all clinical information and not involved in the revision procedures. RESULTS: Overall, 45% (24 of 53) experienced complications and 38% (20 of 53) underwent rerevision. Ten-year survival free from rerevision for revised MoMHRs was 63% (95% confidence interval [CI], 48%-74%). Revision indications were not associated with differences in the frequency of complications or repeat revisions. With the numbers available, 10-year survival free from rerevision for pseudotumor revisions (56%; 95% CI, 30%-76%) was not different from the fracture (68%; 95% CI, 42%-85%; p = 0.359) and other groups (63%; 95% CI, 35%-81%; p = 0.478). Pseudotumor revisions had inferior OHSs (median, 21; range, 2-46; p = 0.007) and UCLA scores (median, 2; range, 2-7; p = 0.0184) compared with fracture and other revisions. Ten-year survival free from rerevision after femoral-only revision using another large-diameter MoM bearing was lower (p = 0.0498) compared with all component revisions using non-MoM bearings. After controlling for potential confounding variables such as age, sex, and revision indication, we found femoral-only revision as the only factor predicting rerevision (hazard ratio, 5.7; 95% CI, 1.1-29; p = 0.040). CONCLUSIONS: Poor implant survivorship and frequent complications were observed at a median of 10 years after MoMHR revision. However, patients undergoing femoral-only revisions with large-diameter MoM bearings had the worst survivorship, whereas patients revised for pseudotumor had the most inferior patient-reported outcomes. Our findings suggest these two patient subgroups require regular surveillance after MoMHR revision. LEVEL OF EVIDENCE: Level III, therapeutic study.

Sensitivity and Specificity of Metal Ion Levels in Predicting "Pseudotumors" due to Taper Corrosion in Patients With Dual Taper Modular Total Hip Arthroplasty.

BACKGROUND: Currently, no serum metal ion threshold exists to identify adverse tissue reactions in total hip arthroplasty (THA) patients with taper corrosion. Our study aims to investigate the sensitivity and specificity of serum metal ions in detecting taper corrosion related pseudotumors in patients with dual taper modular THA. METHODS: A total of 148 patients with dual taper modular THA were investigated: (1) 90 patients with pseudotumors detected with metal artifact reduction sequence-magnetic resonance imaging (MARS-MRI) and (2) 58 patients without pseudotumors on MARS-MRI. Receiver operating characteristic curves were constructed to determine the sensitivity and specificity using different metal ion thresholds. The severity of intraoperative tissue damage was correlated with preoperative metal ion levels. RESULTS: Pseudotumor was associated with higher cobalt (5.0 µg/L vs 3.7 µg/L, P < .01) and Co/Cr ratio (6.0 vs 3.7, P < .01). The sensitivity and specificity for cobalt level of 2.8 µg/L and Co/Cr ratio of 3.8 in detecting taper corrosion-related pseudotumors on MARS-MRI was 88% and 32% and 70% and 50%, respectively. Higher intraoperative tissue damage grades demonstrated significantly higher Co/Cr ratios (8.6 vs 3.4, P = .03). CONCLUSION: Although metal ion levels alone should not be relied on as the sole parameter to determine revision surgery, cobalt level >2.8 µg/L and the Co/Cr ratio >3.8 are useful clinical diagnostic adjuncts in the systematic clinical evaluation for taper corrosion-related adverse tissue reactions in patients with dual modular taper THA.

Metal-on-Metal Hip Replacement: MRI Signal Intensities of Different Body Tissues and Their Relations to Blood Metal Ion Levels.

BACKGROUND: Metal-on-metal total hip prostheses (MoM-THR) have been shown to produce hypersensitivity reactions and fluid collection (pseudotumor) by the hip as well as high blood metal ions levels (BMILs). OBJECTIVES: To evaluate the magnetic resonance imaging (MRI) signal-to-noise ratio (S/N) in selected body tissues around the hip of patients who underwent MoM hip replacement and to correlate to BMILs. METHODS: Sixty-one MRI hip examinations in 54 post-MoM-THR patients (18 males, 36 females, mean age 65 years) were retrospectively evaluated independently by two readers. The mean S/N ratio in a region of interest was calculated for periprosthetic pseudotumor collection (PPC), the bladder, fat, and muscle on axial T1w, FSE-T2w, and short tau inversion recovery (STIR) sequences on the same location. BMILs were retrieved from patient files. RESULTS: PPC was detected in 32 patients (52%) with an average volume of 82.48 mm3. BMIL did not correlate with the presence of PPCs but positively correlated with the PPC's volume. A trend for positive correlation was found between BMILs and S/N levels of STIR images for muscle and bladder as well as for PPC and cobalt levels. A trend for correlation was also seen between BMIL with PPC's T1 w S/N. CONCLUSIONS: Alteration of MRI S/N for different hip tissues showed a tendency for correlation with BMILs, possibly suggesting that metal deposition occurs in the PPC as well as in the surrounding tissues and bladder.

Metal-on-metal total hip arthroplasty: risk factors for pseudotumours and clinical systematic evaluation.

The potential advantages of contemporary MoM THA implants include less volumetric wear with subsequent reduction of polyethylene wear-induced osteolysis and greater component stability with use of large-diameter femoral heads. However, there have been concerns regarding significantly elevated revision rates in MoM THA due to MoM-related complications such as adverse local tissue reaction (pseudotumour) formation. The increased failure rate in MoM hip arthroplasty is associated with the generation of biologically active, nanometer sized metal particles from the MoM bearing surfaces and taper junctions, which result in the development of a localized, adverse periprosthetic soft tissue response. The focus of this article is to provide an update on (1) implant, surgical and patient factors associated with adverse local tissue reactions (pseudotumours) and (2) the clinical systematic evaluation and management of patients with MoM hip arthroplasty based on the currently available evidence. There should be a low threshold to conduct a systematic clinical evaluation of patients with MoM hip arthroplasty as early recognition and diagnosis will allow the initiation of prompt and appropriate treatment. As a symptomatic MoM total hip arthroplasty may have intrinsic and extrinsic causes, patients should be evaluated systematically, utilizing risk stratification algorithms. Although specialized laboratory tests such as metal ion levels and cross sectional imaging modalities such as MARS MRI can be used to facilitate clinical decision making, over-reliance on any single investigative tool in the clinical decision-making process should be avoided. Further research is required to obtain a better understanding of implant and patient risk factors associated with tribocorrosion in MoM total hip arthroplasty.

Inflammatory myofibroblastic tumor as a second neoplasm after Wilms tumor.

We report two survivors of Wilms tumor (WT) who developed inflammatory myofibroblastic tumor (IMT). The first patient had IMT in the mainstem bronchus 1 year after WT therapy that included vincristine, dactinomycin, doxorubicin (VDA) and whole lung radiation therapy (XRT). The second patient had IMT in the cecum 7 years after WT therapy consisting of VDA and abdominal XRT. The unlikely co-occurrence of WT and IMT suggests a genetic link between these tumors or that IMT can arise as a complication of cancer therapy. IMT should be considered in WT survivors who develop secondary tumors, especially at unusual sites.

What are the predictors and prevalence of pseudotumor and elevated metal ions after large-diameter metal-on-metal THA?

BACKGROUND: Soft tissue masses, or "pseudotumors," around metal-on-metal total hip arthroplasty (MoM THA) have been reported frequently; however, their prevalence remains unknown. Several risk factors, including elevated metal ion levels, have been associated with the presence of pseudotumor, although this remains controversial. QUESTIONS/PURPOSES: The goals of this study were to (1) determine the prevalence of pseudotumors after large-diameter head MoM THA; (2) identify risk factors associated with pseudotumor formation and elevated metal ion levels; and (3) determine the early failure rate of large-diameter MoM THA. METHODS: Between December 2005 and November 2012, 258 hips (215 patients) underwent large-diameter head primary MoM THA at our institution. Clinical followup was obtained in 235 hips (91%). Using an inclusion criteria of a minimum followup of 1 year, a subset of 191 hips (mean followup, 4 years; range, 1-7 years) was recruited for high-resolution ultrasound screening for the presence of pseudotumor. Whole blood cobalt and chromium ion levels, UCLA activity level, WOMAC score, patient demographics as well as surgical, implant, and radiographic data were collected. Bivariate correlations and multivariate log-linear regression models were used to compare the presence of pseudotumor and elevated metal ions with all other factors. RESULTS: Ultrasound detected a solid, cystic, or mixed mass in 20% hips (38 of 191). No correlation was found between the presence of pseudotumor and any risk factor that we examined. After controlling for confounding variables, elevated cobalt ions were correlated (p<0.001, R=0.50, R2=0.25) with smaller femoral head size, the presence of bilateral MoM THA, and female sex. Elevated chromium ions were correlated (p<0.001, R=0.59, R2=0.34) with smaller femoral head size, presence of bilateral MoM THA, and lower body mass index. The overall survival of MoM THA was 96% at a mean followup of 4.5 years (range, 2-8 years). CONCLUSIONS: With the numbers available, we found no associations between the presence of pseudotumor and the potential risk factors we analyzed, including elevated metal ion levels. Further work is needed to explain why larger femoral head sizes resulted in lower metal ion levels despite being associated with higher early failure rates in joint registry data. LEVEL OF EVIDENCE: Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Inflammatory pseudotumor around metal-on-polyethylene total hip arthroplasty in patients with ankylosing spondylitis: description of two cases and review of literature.

Inflammatory pseudotumor has been commonly reported in patients undertaking total hip replacement (THR) for different reasons. The precise etiology of this biological reaction and whether the primary disease has an influence on pseudotumor formation remain unclear. There seems to be a consensus that metal ions and debris do play an important role during this process. Recently, however, compared to metal particles along, immune response induced by metal particles attracts more attention. We present two cases of pseudotumor who have accepted THR for ankylosing spondylitis (AS) and later required revision surgery and hindquarter amputation, respectively. By thorough literature review, we tried to investigate the association between inflammatory pseudotumors and immunology.

Usefulness of ultrasonography for detection of pseudotumors after metal-on-metal total hip arthroplasty.

We retrospectively analyzed 83 metal-on-metal total hip arthroplasties in 74 patients. Ultrasonography and magnetic resonance imaging (MRI) of each hip were performed to detect abnormal patterns and pseudotumors. We examined the reliability of ultrasonography for detecting pseudotumors in comparison with MRI. We also compared the acetabular component inclination between patients with and without pseudotumors. The mean positive and negative predictive values for pseudotumor detection by ultrasonography were 65% and 91%, respectively. The mean positive and negative likelihood ratios were 5.78 and 0.32, respectively. There was no clear association between pseudotumor presence and acetabular component inclination. We concluded that ultrasonography is a suitable technique to screen for the presence of pseudotumors. We also need to distinguish between bearing-related and taper junction corrosion-related complications.

Large fixed-size metal-on-metal total hip arthroplasty: higher serum metal ion levels in patients with pain.

PURPOSE: Recently, concerns have arisen about metal-on-metal (MoM) total hip arthroplasty (THA). Therefore, the purpose of this cross-sectional cohort study was to describe the incidence of pain, pseudotumours, revisions and the relation between elevated metal ion levels, functional outcome and quality of life after MoM THA. METHODS: In 351 patients, 377 MoM THA with a fixed-size 38-mm head were evaluated with a mean follow-up of 30 months (range 11-58). Evaluation included pain, serum metal ions, patient-reported questionnaires (Short Form-36 [SF-36], Hip disability and Osteoarthritis Outcome Score [HOOS] and the Oxford Hip Score [OHS]) and radiological imaging. Sixteen patients did not participate in the screening. RESULTS: One hundred and eighteen (35 %) patients reported pain and showed significantly higher cobalt and chromium levels compared to patients without pain. Median serum cobalt levels were 4.4 µg/l (interquartile range [IQR] 6.6) and chromium levels were 3.6 µg/l (IQR 4.8). Patients with cobalt levels of ≤5 µg/l reported significantly better outcome on the SF-36 and HOOS. Fifty-seven pseudotumours were identified in 227 THAs. A revision rate of 19 % was observed. CONCLUSIONS: In conclusion, 35 % of the patients experienced pain after MoM THA. These patients showed significantly higher serum metal ion levels. The patient-reported questionnaires indicated significantly better outcome in patients with cobalt levels ≤5 µg/l.

Pseudotumor formation and serum ions after large head metal-on-metal stemmed total hip replacement. Risk factors, time course and revisions in 706 hips.

INTRODUCTION: The incidence and natural course of pseudotumors in metal-on-metal total hip arthroplasties is largely unknown. The objective of this study was to identify the true incidence and risk factors of pseudotumor formation in large head metal-on-metal total hip arthroplasties. MATERIALS AND METHODS: Incidence, time course and risk factors for pseudotumor formation were analysed after large femoral head MoM-THA. We defined a pseudotumor as a (semi-)solid or cystic peri-prosthetic soft-tissue mass with a diameter ≥2 cm that could not be attributed to infection, malignancy, bursa or scar tissue. All patients treated in our clinic with MoM-THA's were contacted. CT scan, metal ions and X-rays were obtained. Symptoms were recorded. RESULTS: After median follow-up of 3 years, 706 hips were screened in 626 patients. There were 228 pseudotumors (32.3 %) in 219 patients (35.0 %). Pseudotumor formation significantly increased after prolonged follow-up. Seventy-six hips (10.8 %) were revised in 73 patients (11.7 %), independent risk factors were identified. Best cutoff point for cobalt and chromium was 4 µg/l (68 and 77 nmol/l). CONCLUSIONS: This study confirms a high incidence of pseudotumors, dramatically increasing after prolonged follow-up. Risk factors for pseudotumors are of limited importance. Pain was the strongest predictor for pseudotumor presence; cobalt chromium and swelling were considered poor predictors. Cross-sectional imaging is the main screening tool during follow-up.