Introduction: Edge-loading, a phenomenon whereby the femoral component comes into contact with the edge of the acetabular component, has been suggested to increase wear in metal-on-metal hip resurfacing arthroplasty (MoMHRA).
Introduction:
Introduction: Symptomatic abnormal soft-tissue masses relating to the hip joint, such as those described as pseudotumours, are being increasingly reported following metal-on-metal hip resurfacing arthroplasty (MoMHRA). These were found to be locally destructive, requiring revision surgery in a high proportion (75%) of patients. Lymphocyte infiltrations seen in pseudotumours were similar to aseptic lymphocyte vascular associated lesion (ALVAL), which is thought to represent a T-lymphocyte-mediated delayed type hypersensitivity. Therefore, a delayed hypersensitivity reaction to nickel (Ni), chromium (Cr) or cobalt (Co) has been suggested to play a role in pseudotumour aetiology. In patients with bilateral MoMHRA who presented with symptoms on one side, subsequent scans have demonstrated pseudotumours both on the symptomatic and asymptomatic side. Thus, there are concerns that there may be an appreciable number of asymptomatic pseudotumours that surgeons are unaware of and these may eventually become symptomatic. Aim: The aims of this study were:. to determine the prevalence of asymptomatic pseudotumours after MoMHRA; and. to measure Co and Cr ion levels as well as lymphocyte proliferation responses to Ni, Co and Cr (the principal elements in the CoCr alloy used in MoMHRA) in MoMHRA patients with and without asymptomatic pseudotumours. Methods: A total of 201 MoMHRA implanted hips in 158 patients (97 male, 61 female) with a mean age of 56 years (range 33–73 years) were evaluated. The mean follow-up was 61 months (range 13–88 months). Resurfacing devices implanted included 128 Birmingham Hip Resurfacing, 66 Conserve Plus and seven ReCap. The control groups included additional 20 patients, 10 male and 10 female (a mean age 68 years, range 57–80 years) with metal-on-polyethylene total hip arthroplasty and a further 22 age-matched patients (a mean age 55 years) without any metal implants. Ultrasound was used as the initial imaging modality and MRI was used to assess the extent of the identified masses. Patients with a soft-tissue mass had ultrasound-guided aspiration or core biopsy performed. Venous blood samples were collected in all patients for serum cobalt and chromium ion levels analysis using Inductively-Coupled Plasma Mass Spectrometer and lymphocyte transformation tests (LTT). The Oxford Hip Score (OHS) was used to measure the functional outcomes of patients. Acetabular component abduction angle was measured from standardised anteroposterior pelvis radiographs. Results: Prevalence –
Hip resurfacing may be a useful surgical procedure when patient selection is correct and only implants with superior performance are used. In order to establish a body of evidence in relation to hip resurfacing, pseudotumour formation and its genetic predisposition, we performed a case-control study investigating the role of HLA genotype in the development of pseudotumour around MoM hip resurfacings. All metal-on-metal (MoM) hip resurfacings performed in the history of the institution were assessed. A total of 392 hip resurfacings were performed by 12 surgeons between February 1st 2005 and October 31st 2007. In all cases, pseudotumour was confirmed in the preoperative setting on Metal Artefact Reduction Sequencing (MARS) MRI. Controls were matched by implant (ASR or BHR) and absence of pseudotumour was confirmed on MRI. Blood samples from all cases and controls underwent genetic analysis using Next Generation Sequencing (NGS) assessing for the following alleles of 11 HLA loci (A, B, C, DRB1, DRB3/4/5, DQA1, DQB1, DPB1, DPA1). Statistical significance was determined using a Fisher's exact test or Chi-Squared test given the small sample size to quantify the clinical association between HLA genotype and the need for revision surgery due to pseudotumour. Both groups were matched for implant type (55% ASR, 45% BHR in both the case and control groups). According to the ALVAL histological classification described by Kurmis et al., the majority of cases (63%, n=10) were found to have group 2 histological findings. Four cases (25%) had group 3 histological findings and 2 (12%) patients had group 4 findings. Of the 11 HLA loci analysed, 2 were significantly associated with a higher risk of pseudotumour formation (DQB1*05:03:01 and DRB1*14:54:01) and 4 were noted to be protective against pseudotumour formation (DQA1*03:01:01, DRB1*04:04:01, C*01:02:01, B*27:05:02). These findings further develop the knowledge base around specific HLA genotypes and their role in the development of pseudotumour formation in MoM hip resurfacing. Specifically, the two alleles at higher risk of pseudotumour formation (DQB1*05:03:01 and DRB1*14:54:01) in MoM hip resurfacing should be noted, particularly as patient-specific genotype-dependent surgical treatments continue to develop in the future.
Objectives.
We report 17 patients (20 hips) in whom metal-on-metal resurfacing had been performed and who presented with various symptoms and a soft-tissue mass which we termed a pseudotumour. Each patient underwent plain radiography and in some, CT, MRI and ultrasonography were also performed. In addition, histological examination of available samples was undertaken. All the patients were women and their presentation was variable. The most common symptom was discomfort in the region of the hip. Other symptoms included spontaneous dislocation, nerve palsy, a noticeable mass or a rash. The common histological features were extensive necrosis and lymphocytic infiltration. To date, 13 of the 20 hips have required revision to a conventional hip replacement. Two are awaiting revision. We estimate that approximately 1% of patients who have a metal-on-metal resurfacing develop a pseudotumour within five years. The cause is unknown and is probably multifactorial. There may be a toxic reaction to an excess of particulate metal wear debris or a hypersensitivity reaction to a normal amount of metal debris. We are concerned that with time the incidence of these pseudotumours may increase. Further investigation is required to define their cause.
We report on a group of 20 metal-on-metal resurfaced hips (17 patients) presenting with a soft tissue mass associated with various symptoms. We describe these masses as pseudotumours. All patients underwent plain radiography and fuller investigation with CT, MRI and ultrasound. Where samples were available, histology was performed. All patients in this series were female. Presentation was variable; the most common symptom was pain or discomfort in the hip region. Other symptoms included spontaneous dislocation, nerve palsy, an enlarging mass or a rash. The common histological features were extensive necrosis and lymphocytic infiltration. Fourteen of the 20 cases (70%) have so far required revision to a conventional hip replacement and their symptoms have either settled completely or improved substantially since the revision surgery. Two of the three bilateral cases have asymptomatic pseudotumours on the opposite side. We estimate that about 1% of patients develop a pseudotumour in the first five postoperative years after a hip resurfacing. The cause of these pseudotumours is unknown and is probably multi-factorial, further work is required to define this; they may be manifestations of a metal sensitivity response. We are concerned that with time the incidence of these pseudotumours will increase.
Pseudotumors have been reported following metal-on-metal total hip arthroplasty (THA); however, the natural history and longitudinal imaging findings of pseudotumors have yet to be fully analyzed. Our hypothesis was that pseudotumor size might change over time following metal-on-metal THA. This hypothesis was studied longitudinally using magnetic resonance imaging (MRI). Screening for pseudotumors was performed using MRI after large-diameter metal-on-metal THA. Initial MRI was conducted at a mean of 36 months postoperatively. Follow-up MRI was performed at a mean of 20 months after the detection of 24 pseudotumors in 20 asymptomatic patients. Pseudotumors were classified as cystic, solid, and mixed types. Fourteen hips were characterized as cystic type and 10 hips were defined as mixed type. There were three men and 17 women with a mean age of 63 years. Pseudotumor size was determined on MRI by manually outlining the greatest size of the mass. Serum cobalt and chromium ion levels were measured in nine patients with unilateral THA at the time of MRI. Statistical analysis was performed using the Kruskal-Wallis test and chi square test to compare age, gender, BMI, head diameter, cup inclination, cup anteversion, and pseudotumor type among changes of pseudotumor size. We compared the pseudotumor size for the three groups (increase in size, no change, decrease in size) using Kruskal-Wallis test and Mann-Whitney U test. Wilcoxon signed-rank test was used to compare median serum metal ion levels over time. A p value < 0.05 was considered significant. This study was approved by the ethics committee of our institution, and all patients provided informed consent.Introduction
Materials and Methods
Pseudotumor or high grade ALVAL (aseptic lymphocyte-dominated vasculitis-associated lesion) development around total hip replacements secondary to local metal debris generation – especially in the setting of metal-on-metal bearings – is a well-recognised histopathologic phenomenon. Recent work has suggested a strong genetic correlation with an individual's risk of such lesion development following metal exposure. Emerging data have highlighted a similar potential concern around total knee replacements (TKRs), particularly with increasing construct modularity. To date, the body-of-knowledge pertaining to TKR-associated ALVALs has largely been limited to individual case reports or small retrospective case series’, with no large-scale investigation looking at this potential complication. This study sought to establish the preliminary prevalence of pseudotumor or high grade ALVAL formation seen at the revision of primary TKRs and to establish the correlation between histologic ALVAL grade and patient-reported functional outcomes. Findings of 1263 consecutive patients undergoing revision knee surgery, at a high-volume referral center, were reviewed. 161 cases of active infection were excluded. Complete histopathology reports were subsequently available for 321 (29.1%) non-infective cases. Each case was independently histologically-classified using a previously validated scoring system reflecting ALVAL grade. Post-operative patient-reported outcomes measures (PROMs) were available for 134 patients (41.7%), allowing direct correlation between functional performance and the established histopathology results.Background
Methods
Our primary purpose was to study the rate of occurrence and the natural course of pseudotumors in patients who had not required a revision procedure. Our secondary purpose was to see if there is a relationship between serum metal ion analysis and clinical symptoms with metal-on-metal (MOM) hip arthroplasty. We used repeated metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) to screen 17 unrevised hips (mean patient age 63.0 years, 43 to 83 years) with pseudotumors and 26 hips (mean patient age 63.2 years, 47 to 83 years) without pseudotumors. Patients with 17 MOM, 17 ceramic-on-polyethylene (COP) and 7 ceramic on ceramic (COC) who had undergone repeated MARS MRI were evaluated with or without any symptoms. We utilized MARS MRI to score the type of pseudotumors using the Hart method. The mean post-operative time to the first MARS MRI scan was 30.0 months (8 to 96), and the time between the first and the second MARS MRI scan was eleven months (6 to 12). Serum Cr and Co ion measurements were undertaken at the time of both MRIs and analyzed only after MOM total hip arthroplasty.Purpose
Patients and Methods
Between April 2008 and February 2012, we implanted 159 large-diameter MOM stemmed THA with head diameters of 38–50mm. There were 6–38mm, 22–40mm, 42–42mm, 42–44mm, 24–46mm, 13–48mm, 4–50mm, 5–52mm, and one-54mm heads implanted in 138 patients (21 males and 117 females). The pre-operative diagnoses included: 120 OAs, 12 IONs, 4 femoral neck fractures, one RA, and one post-traumatic OA. Their ages were 40–86 years (avg. 63.6 yrs). Follow up was 4 to 67 months post implantation (avg. 40.4 months). All implants were manufactured by one company (Wright Medical Technology, Arlington, TN, USA). The stems were of a standard titanium-aluminum alloy, either 44 ANCA-FIT or 115 PROFEMUR Z non-cemented stems. Acetabular components were all CONSERVE PLUS cobalt-chromium monoblock shells. Heads were also fabricated out of cobalt-chromium alloy, with modular junctions. Patients with complaints of groin pain and/or swelling or hip instability underwent MRI examination in order to detect the presence of fluid collections or soft tissue masses. The statistical correlation between abnormal findings on MRI and age, gender, head diameter, component position and duration post-surgery was performed. 35 hips in 31 patients (22.0%) were found to have either a fluid collection or “pseudotumor” on MRI. These were in 5 males and 26 female patients. According to Hart's MRI classification, they were classified 21 hips in Type 1, twelve hips in Type 2, and two hips in Type 3 (Fig. 1, 2 and 3). 8 hips in 8 patients who had any pseudotumors were undergone revision THA (Fig. 4, 5 and 6). All hips had corrosions at head-neck taper junctions (Fig. 7). There was no difference in age between these two groups of patients (63.7 vs. 63.6 yrs.), but a significant difference in duration from the time of implantation of two groups (23.9 vs. 44.8 months). There appeared to be no significant difference between the mean head diameter of the two groups, 43.2mm and 44.0mm respectively. There was no statistical difference between the two groups with regard to implant orientation: cup inclination 18–70 degrees (41.8 vs. 43.6 degrees); cup anteversion −13–49 degrees (15.1 vs. 14.7 degrees); stem anteversion 2–48 degrees (20.1 vs. 23.3 degrees); and stem offset 17.5–56.2mm (38.2 vs. 37.8mm). Furthermore, according to Lewinnek's safe zone, there was no difference in cup orientation between the two groups (Fig. 8). When we investigated the types of modular neck, the hips having any pesudotumors tended to have long or varus necks. In this study, it is important to emphasize that the appearance of symptoms and development of a pseudotumor occurred early after a MOM THA in some patients. Also it will be important to subject all patients to MRI examination to evaluate the possibility of “silent” fluid collections and pseudotumors. In large-diameter head metal-on-metal stemmed THAs, femoral stems having long or varus neck may contribute to head-neck junction failure.
Tribological studies of hip arthroplasty suggest that larger diameter metal-on-metal (MOM) articulations would produce less wear than smaller diameter articulations. Other advantages using these large femoral heads implants include better stability with lower dislocation rates and improved range of motion. The aim of the present study was to compare chromium (Cr), cobalt (Co) and titanium (Ti) ion concentrations up to 1-year after implantation of different large diameter MOM total hip arthroplasty (THA).
Statistical group comparison revealed significant difference for Cr (p=0.006), Co (p=0.047) and Ti (p=<
0.001). With Biomet implants presenting the best results for Cr and Co and Zimmer the highest Ti level.
Pseudotumour formation is being reported with increasing frequency in failing metal-on-metal hip resurfacings and replacements. This mode of failure complication has also been reported with metal-on-polyethylene bearing bearings when it is usually associated with evidence of surface corrosion and no apparent wear at the head–neck taper. We present a case with evidence of taper wear and damage secondary to corrosion in an uncemented total hip replacement with a metal on polyethylene articulation (TMZF (Titanium, Molybdenum, Zirconium and Ferrous) Accolade® stem, Trident® HA coated acetabular shell, Low Friction Ion Treatment (LFIT™) Cobalt-Chrome anatomic head (40 mm), X3® polyethylene liner) A 69 year old woman had a THR in 2008. A year later she started to complain of lateral based hip pain. Clinical examination and initial imaging indicated trochanteric bursitis and heterotopic bone formation. The symptoms became worse over the next 3 years and the patient was listed for exploration and excision of heterotopic bone. Extensive pseudotumour was encountered deep to bursa and adherent to capsule. Abductors, external rotators and vastus lateralis were spared. There was minimal calcar osteolysis and marginal erosion in superior acetabulum. There was no obvious wear on the articulating surfaces of the femoral head and polyethylene inlay of the socket nor was there any evidence of neck-to-rim impingement or edge loading. There was visible blackening of both the taper and trunnion after femoral head removal.Case
Surgical findings
Recently, a series of locally destructive soft tissue pseudotumour has been reported in patients following metal-on-metal hip resurfacing arthroplasty (MoMHRA), requiring revision surgery in a high percentage of patients. Based on the histological evidence of lymphocytic infiltration, a delayed hypersensitivity reaction to nickel (Ni), chromium (Cr) or cobalt (Co) has been suggested to play a role in its aetiology. The aim of this study was to investigate the incidence and level of hypersensitivity reaction to metals in patients with pseudotumour.
Group 1: MoMHRA patients with pseudotumours, detected on the ultrasound and confirmed with MRI (n=6, 5 F:1 M, mean age 53 years); Group 2: MoMHRA patients without pseudotumours (n=13, 7 F:6 M, mean age 55 years); and Group 3: age-matched control subjects without metal implants (n=6, 4 F:2 M, mean age 54 years). Lymphocyte transformation tests (LTT) were used to measure lymphocyte proliferation responses to metals. Peripheral blood mononuclear cells were isolated from heparinized blood samples using standard Ficoll–Hypaque® (Pharmacia). The PBMC were cultured at a cell density of 106 cells/mL. Culture was set up in the presence of either:
medium alone; nickel chloride (Sigma; 10-4M-10-6M); cobalt chloride (10-4M-10-6M); and chromium chloride (10-4M-10-6M). After 5 days of culture, cells were pulsed with [3H]-thymidine and proliferation was assessed by scintillation counting. The stimulation index (SI) was calculated by the ratio of mean counts per minute of stimulated to unstimulated cultures. A SI value of greater than 2.0 was interpreted as a positive result.
Large-diameter metal-on-metal (MoM) total hip arthroplasty (THA) has demonstrated unexpected high failure rates and pseudotumour formation. The purpose of this prospective cohort study is to report ten-year results in order to establish revision rate, prevalence of pseudotumour formation, and relation with whole blood cobalt levels. All patients were recalled according to the guidelines of the Dutch Orthopaedic Association. They underwent clinical and radiographical assessments (radiograph and CT scan) of the hip prosthesis and whole blood cobalt ion measurements. Overall, 94 patients (95 hips) fulfilled our requirements for a minimum ten-year follow-up.Aims
Methods