Purpose. 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. Patients and Methods. 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
PURPOSE:. Wright Medical has a long history of modular neck hip implants but had fracture issues with the original titanium necks. They subsequently changed to chrome cobalt modular necks. Direct contact between these dissimilar metal parts in the modular femoral component brings into consideration the possibility of similar adverse reactions of metal-on-metal articulations that have been previously described in other designs. METHODS:. A retrospective review of 10 patients with Wright Medical chrome cobalt modular necks who were evaluated with chromium and cobalt metal ion levels as well as Metal Artifact Reduction Sequence (MARS) MRI's was performed. Pseudotumors were classified by MRI based on wall thickness, T1/T2 signal, shape, and location and given a corresponding type of I, II, or III. For each patient, symptoms or lack thereof were recorded, and time since surgery noted. RESULTS:. Of 10 patients tested, 9 were symptomatic, and 1 was asymptomatic. The patient that was asymptomatic at last clinical visit at 14 months post-op while symptomatic patients averaged 18 months since initial surgery before symptoms began. Those with metal-poly articulation had an average cobalt level of 1.6, ceramic-ceramic articulation had level of <1, and metal-on-metal had level of 2.9. Five patients had pseudotumor by MRI (2 type I, 1 type II, and 2 type III pseudotumors). CONCLUSION:. It appears that an unintended consequence of changing from titanium to chrome cobalt modular neck may be occurring secondary to corrosion at neck-stem junction. SIGNIFICANCE: This reaction does not appear to be design-specific as these findings are similar to our findings in Stryker Rejuvenate stems. Surgeons evaluating patients with these and other similar stems should be aware of this complication and consider ion testing and
Introduction. Metal Artefact Reduction Sequence (MARS) MRI is being increasingly used to detect soft tissue inflammatory reactions surrounding metal-on-metal hip replacements. The UK MHRA safety alert announced in April 2010 recommended cross-sectional imaging such as MRI for all patients with painful MOM hips. The terms used to describe the findings include bursae, cystic lesions and solid masses. A recently used term, pseudotumour, incorporates all of these lesions. We aimed to correlate the pattern of abnormalities on MRI with clinical symptoms. Method. Following our experience with over 160
The prevalence of pseudotumours in patients with large-head metal-on-metal (MOM) THA has been the subject of implant recalls and warnings from various regulatory agencies. To date, there is no consensus on whether ultrasound or MRI is superior for the detection and following the progression of pseudotumours. Ultrasound is relatively cheap but can be operator dependent.
Introduction. The MHRA guidelines for metal on metal (MOM) suggest cobalt and chromium levels of more than 7ppb as potential for soft tissue reaction. However, in some patients soft tissue reaction is seen even in the presence of normal serum metal ions levels. Methods. A prospective review of all patients who had metal-on-metal hip arthroplasty was done. Patients who had both serum metal ion levels and
All patients with a MOM THR implanted at our unit were recalled for clinical examination, Oxford hip score, radiographs,
Introduction. Neck-stem corrosion has been associated with Adverse Local Tissue Reaction (ALTR) in dual-taper femoral stems. Several diagnostic tests, of varying specificity and sensitivity, are used to identify ALTR. The purpose of this study was to document the clinical presentation, diagnostic workup and surgical findings in a large cohort of patients with dual modular stems, and use this information to propose an evaluation protocol that assists surgical decision-making. Methods. This is a single center, single surgeon's retrospective case series of 38 patients who underwent 42 primary total hip arthroplasty (THA) with a dual-taper femoral components between March 2010 and May 2011 The evaluation included clinical exam, hip radiographs, labs including serum metal ion levels, metal artifact reduction sequence magnetic resonance imaging (MARS MRI), and fluoroscopic hip aspiration with qualitative and quantitative assessment of synovial fluid. Each hip aspirate was classified into Class 1 (clear, <10cc), 2(brown, clear, >10cc), or 3 (cloudy, turbid, viscous). 20 patients to date have undergone revision THA. Results. 19/42 hips were symptomatic. Serum cobalt levels were elevated in 38/42 patients. 23/42 had abnormal MRI findings. MRI was able to identify abnormalities in 79% (15/19) of symptomatic patients and 35% (8/23) asymptomatic patients. Class 2 and 3 hip aspirates were associated with abnormal MRI (in 86% and 61%, respectively), elevated Cobalt, and a high rate of revision (71% and 72%, respectively). ESR and CRP were normal in most patients (76% and 66%, respectively). A small subset of patients (2/38) with symptoms, normal metal ion levels and normal MRI, had abnormal aspirates (Class 2 or 3) with extensive tissue necrosis at revision. Conclusion. The diagnosis of ALTR can be challenging and requires integrating data from several sources: clinical exam, radiographs, serum metal testing,
Articular cartilage has a limited regeneration capacity, and damage of cartilage often results in the onset of degenerative disease such as osteoarthritis (OA). MRI and CT imaging of cartilage and subchondral bone are becoming increasingly important in early detection and treatment of OA as well as for quantifying quality of tissue-engineered samples. Non-invasive CT scanners have been used to image cartilage tissue with the help of contrast agents. However, since only one energy source is available, imaging information of multiple soft and hard tissues is lost given that the overall x-ray attenuation is measured. Medipix All Resolution System (MARS) CT offers the possibility of applying more than one energy source. It is able to measure the energy of each photon individually and therefore determines the characteristics of attenuation. In this study, an ionic contrast agent (Hexabrix) was used to image the negatively charged extra-cellular matrix component, glycosaminoglycan (GAG), which is abundantly found in the middle and lower layers of healthy cartilage tissue. GAG distribution in the cartilage tissue could be imaged using an inverse relationship with Hexabrix signal (i.e. high signal represents low GAG content). Eight bovine cartilage-bone explants (3mm × 5mm) were incubated in 4 different Hexabrix concentrations ranging from 20% to 50% in PBS. Sections were imaged using the
Background:. Higher than expected revision rates have been observed in large bearing metal-on-metal total hip replacements. We have introduced a metal on metal hip screening clinic at our unit and report the results. Methods:. All patients who had a metal-on-metal total hip replacement implanted at our unit were recalled to clinic. Screening consisted of clinical examination, Oxford hip score, radiographs,
Total knee arthroplasty (TKA) is one of the most common orthopaedic operations performed worldwide and it is largely successful in pain relief and functional recovery. However, when pain persists post-operatively the thorough evaluation must be instituted. Extra-articular causes of knee pain include; hip pathology, lumbar spine degenerative disease or radicular symptoms, focal neuropathy, vascular disease, and chronic regional pain syndrome. Intra-articular causes of knee pain: infection, crepitation/clunk, patella osteonecrosis, patella mal-tracking, soft tissue imbalance, malalignment, arthrofibrosis, component loosening, implant wear, ilio-tibial band irritation, and bursitis. Other causes of pain to rule out are component overhang with soft tissue irritation, recurrent hemarthrosis secondary to synovial impingement or entrapment, non-resurfaced patella, and metal sensitivity. A careful history may reveal previous knee surgeries with delayed healing or prolonged drainage, chronology of sign and symptoms, co-morbid medical conditions, jewel or metal sensitivity. Physical exam should help with specific signs in the operated knee. Targeted local anesthetic blocks are helpful and response to lumbar sympathetic blocks determines presence of CRPS. Lab tests are important: ESR, CRP, WBC, aspiration with manual cell count and diff, leucocyte esterase dipstick, RA titers, metal derm patch testing, nuclear scans, CT best for rotational malalignment, and
Uncemented metal-on-polyethylene total hip arthroplasties (THAs) have had a modular cobalt-chrome alloy head since their introduction in the early 1980's. Retrieval analysis studies and case reports in the early 1990's first reported corrosion between the femoral stem trunnion (usually titanium alloy) and cobalt-chrome alloy femoral head. However, then this condition seemed to disappear for about two decades? There are now numerous recent case series of this problem after metal-on-polyethylene THA, with a single taper or dual taper modular femoral component. Metal ion elevation, corrosion debris, and effusion are caused by mechanically assisted crevice corrosion (MACC). These patients present with diffuse hip pain, simulating trochanteric bursitis, iliopsoas tendinitis, or even deep infection. Trunnion corrosion, with adverse local tissue reaction, is a diagnosis of exclusion, after infection, loosening, or fracture. The initial lab tests recommended are: ESR, CRP, and serum cobalt and chromium ions. With a metal-on-polyethylene THA, a cobalt level > 1ppb is abnormal. Plain radiographs are usually negative, but may show calcar osteolysis or acetabular erosion or cyst.
TKA is one of the most common orthopaedic operations performed worldwide and it is largely successful in pain relief and functional recovery. However, when pain persists post-operatively the thorough evaluation must be instituted. Extra-articular causes of knee pain include; hip pathology, lumbar spine degenerative disease or radicular symptoms, focal neuropathy, vascular disease, and chronic regional pain syndrome. Intra-articular causes of knee pain: infection, crepitation/ clunk, patella osteonecrosis, patella mal-tracking, soft tissue imbalance, malalignment, arthrofibrosis, component loosening, implant wear, ilio-tibial band irritation, and bursitis. Other causes of pain to rule out are component overhang with soft tissue irritation, recurrent hemarthrosis secondary to synovial impingement or entrapment, non-resurfaced patella, and metal sensitivity. A careful history may reveal previous knee surgeries with delayed healing or prolonged drainage, chronology of sign and symptoms, co-morbid medical conditions, jewel or metal sensitivity. Physical exam should help with specific signs in the operated knee. Targeted local anesthetic blocks are helpful and response to lumbar sympathetic blocks determines presence of CRPS. Lab tests are important: ESR, CRP, WBC, aspiration with manual cell count and diff, leukocyte esterase dipstick, RA titers, metal derm patch testing, nuclear scans, CT best for rotational malalignment,, and
Introduction. Mechanically assisted crevice corrosion (MACC) in metal-on-polyethylene (MOP) total hip arthroplasty (THA) is of concern, but its prevalence, etiology and natural history are incompletely understood. Methods. From January 2003 to December 2012, 1356 consecutive THA surgeries using a titanium stem, cobalt chromium alloy femoral head, highly crosslinked polyethylene and a tantalum or titanium acetabular shell were performed. Patients were followed at 1 year, and 5 year intervals for surveillance, but also seen earlier if they had symptoms. Any patient with osteolysis or unexplained pain underwent exam, radiographs, CBC, ESR and CRP, as well as serum cobalt (Co) and chromium (Cr) level.
It is a not so uncommon clinical scenario: well-fixed, well-aligned, balanced total knee arthroplasty with continued pain. However, radiographs also demonstrate an unresurfaced patella. The debate continues and the controversy remains as whether or not to routinely resurface the patella in total knee arthroplasty. In perhaps the most widely referenced article on the topic, the overall revision rates were no different between the resurfaced (9%) and the unresurfaced (12%) groups and thus their conclusion was that similar results can be obtained with and without resurfacing. However, a deeper look in to the data in this study shows that 4 times more knees in the unresurfaced group were revised for patellofemoral problems. A more recent study concluded that selectively not resurfacing the patella provided similar results when compared to routinely resurfacing. The study does emphasise however, that this conclusion depends greatly on femoral component design and operative diagnoses. This suggests that selective resurfacing with a so-called “patella friendly” femoral component in cases of tibio-femoral osteoarthritis, is a safe and effective strategy. Finally, registry data would support routine resurfacing with a 2.3 times higher relative risk of revision seen in the unresurfaced TKA. Regardless of which side of the debate one lies, the not so uncommon clinical scenario remains; what do we do with the painful TKA with an unresurfaced patella. Precise and accurate diagnosis of the etiology of a painful TKA can be very difficult, and there is likely a strong bias towards early revision with secondary patellar resurfacing in the painful TKA with an unresurfaced TKA. At first glance, secondary resurfacing is associated with relatively poor outcomes. Correia, et al. reported that only half the patients underwent revision TKA with secondary resurfacing had resolution of their complaints. Similarly, only 53% of patients in another series were satisfied with the procedure and pain relief. The conclusions that can be drawn from these studies and others are that either routine patellar resurfacing should be performed in all TKA or, perhaps more importantly, we need to better understand the etiology of pain in an otherwise well-aligned, well-balanced, well-fixed TKA. It is this author's contingency that the presence of an unresurfaced patella leads surgeons to reoperate earlier, without truly identifying the etiology of pain or dissatisfaction. This strong bias; basically there is something more that can be done, therefore we should do it, is the same bias that leads to early revision of partial knee arthroplasty. While very difficult, we as knee surgeons should not revise a partial knee or secondarily resurface a patella due to pain or dissatisfaction. Doing so, unfortunately, only works about half the time. The diagnostic algorithm for evaluating the painful, uresurfaced TKA includes routinely ruling out infection with serum markers and an aspiration. Pre-arthroplasty radiographs should be obtained to confirm suitability and severity of disease for an arthroplasty. An intra-articular diagnostic injection with Marcaine +/− corticosteroid should provide significant pain relief.
Patients with painful metal-on-metal bearings presenting to the orthopaedic surgeon are a difficult diagnostic challenge. The surgeon must go back to basic principles, perform a complete history and physical exam, obtain serial radiographs and basic blood work (ESR, CRP) to rule out common causes of pain and determine if the pain is, or is not, related to the bearing. The Asymptomatic MoM Arthroplasty: Patients will present for either routine follow up, or because of concerns re: their bearing. It is important to emphasise that at this point the vast majority of patients with a MoM bearing are indeed asymptomatic and their bearings are performing well. The surgeon must take into account: a) which specific implant are they dealing with and what is its track record; b) what is the cup position; c) when to perform metal ion testing; d) when to perform further soft tissue imaging (MARS MRI, Ultrasound); e) when to discuss possible surgery. Painful MoM THA causes not related to the bearing couple: These can be broken down into two broad categories. Causes that are Extrinsic to the hip include: spine, vascular, metabolic and malignancy. Causes that are Intrinsic to the hip can either be Extracapsular (iliopsoas tendonitis and trochanteric bursitis) or Intracapsular (sepsis, loosening, thigh pain, prosthetic failure). Painful MoM THA causes related to the bearing couple: There are now described a number of possible clinical scenarios and causes of pain that relate to the metal-on-metal bearing couple itself: a) local hypersensitivity reaction without a significant soft tissue reaction; b) local hypersensitivity reaction with a significant soft tissue reaction; c) impingement and soft tissue pain secondary to large head effect. Metal ions: obtaining serum, or whole blood, cobalt and chromium levels is recommended as a baseline test. However, there is no established cutoff level to determine with certainty if a patient is having a hypersensitivity reaction. A 7 parts per billion cutoff has been suggested. This gives high specificity, but poor sensitivity. Metal ions therefore can be used as a clue, and one more test in the workup, but cannot be relied upon in isolation to make a diagnosis.
Metal-on-metal bearing surfaces were used frequently until recently because of the potential for decreased wear and the ability to use large femoral heads which can reduce instability. However, data reported in the Australian registry over the past 5 years demonstrated an increase in failure rates compared to metal-on-polyethylene bearings. In addition, adverse local tissue reactions (ALTR) associated with pseudotumors and destruction of the soft tissue around the joint have led to revision of these implants. Unfortunately, at the present time there is no optimal management strategy that has been delineated for metal-on-metal implants because of a lack of evidence. The biologic response to metal-on-metal implants is usually local but may be systemic. The management of these patients is complex because patients may have pseudotumors and/or elevated metal ion levels and be asymptomatic. In addition, there are a number of intrinsic causes (loosening, infection, iliopsoas tendinitis) and extrinsic causes (spinal disease, trochanteric bursitis) that can be a source of pain. There is no evidenced based approach to manage these patients and no single test should be used to determine treatment. A thorough clinical evaluation is essential and blood tests are necessary to rule out infection. Imaging studies including plain radiographs and a
The prevalence of pseudotumours in patients with large-head metal-on-metal (MOM) THA has been the subject of implant recalls and warnings from various regulatory agencies. To date, there is no consensus on whether ultrasound or MRI is superior for the detection of pseudotumours. Ultrasound is relatively cheap but can be operator dependent.
Metal on metal bearing surfaces were used frequently until recently because of the potential for decreased wear and the ability to use large femoral heads which can reduce instability. However, data reported in the Australian registry over the past 5 years demonstrated an increase in failure rates compared to metal on polyethylene bearings. In addition, adverse local tissue reactions (ALTR) associated with pseudotumors and destruction of the soft tissue around the joint have led to revision of these implants. Unfortunately, at the present time there is no optimal management strategy that has been delineated for metal on metal implants because of a lack of evidence. The biologic response to metal on metal implants is usually local but may be systemic. The management of these patients is complex because patients may have pseudotumors and/or elevated metal ion levels and be asymptomatic. In addition, there are a number of intrinsic causes (loosening, infection, iliopsoas tendinitis) and extrinsic causes (spinal disease, trochanteric bursitis) that can be a source of pain. There is no evidence based approach to manage these patients and no single test should be used to determine treatment. A thorough clinical evaluation is essential and blood tests are necessary to rule out infection. Imaging studies including plain radiographs and a
Metal-on-metal bearings (MoM) saw an increase in global utilisation in the last decade. This peaked in 2008 in the US, with approximately 35% of bearings being hard-on-hard (metal-on-metal, or ceramic-on-ceramic). Beginning in 2008, reports began to surface regarding local soft tissue reactions and hypersensitivity to MoM bearings. A major implant manufacturer recalled a resurfacing device in 2010 after national joint registries demonstrated higher than expected revision rates. Patients with painful MoM bearings are a difficult diagnostic challenge. The surgeon must go back to basic principles, perform a complete history and physical exam, obtain serial radiographs and basic blood work (ESR, CRP) to rule out common causes of pain and determine if the pain is, or is not, related to the bearing. The Asymptomatic MoM Arthroplasty: Patients will present for either routine follow up, or because of concerns regarding their bearing. It is important to emphasise that at this point the vast majority of patients with a MoM bearing are indeed asymptomatic and their bearings are performing well. The surgeon must take into account: a) which specific implant are they dealing with and what is its track record; b) what is the cup position; c) when to perform metal ion testing; d) when to perform further soft tissue imaging (MARS MRI, Ultrasound); e) when to discuss possible surgery. Painful MoM THA causes not related to the bearing couple: These can be broken down into two broad categories. Causes that are Extrinsic to the hip include spine, vascular, metabolic and malignancy. Causes that are Intrinsic to the hip can either be Extracapsular or Intracapsular. Painful MoM THA causes related to the bearing couple: There are now described a number of possible clinical scenarios and causes of pain that relate to the MoM bearing couple itself: A) Local hypersensitivity reaction without a significant soft tissue reaction; B) Local hypersensitivity reaction with a significant soft tissue reaction; C) Impingement and soft tissue pain secondary to large head effect. Factors related to a hypersensitivity reaction: Some patients, and prostheses, seem to be at a higher risk of developing issues following a MoM bearing, although our understanding of the interplay of these factors is still in evolution: patients at risk include all women and patients with smaller component sizes. Implant factors play a role with some implants having higher wear rates and being more prone to corrosion. Special tests: There is ongoing confusion related to the relative value of the various special tests that patients with a painful MoM undergo. A) Metal Ions - obtaining serum, or whole blood, cobalt and chromium levels is recommended as a baseline test. However, there is no established cutoff level to determine with certainty if a patient is having a hypersensitivity reaction. Metal ions therefore can be used as a clue, but cannot be relied upon in isolation to make a diagnosis. B)
Introduction. Complication and revision rates have shown to be high for all metal-on-metal (MoM) bearings, especially for the ASR Hip System (ASR hip resurfacing arthroplasty (HRA) and ASR XL total hip arthroplasty (THA)). This prompted the global recall of the ASR Hip System in 2010. Many studies have previously explored the association between female gender and revision surgery MoM HRA implants; yet less research has been dedicated to exploring this relationship in MoM THA. The first purpose of this study was to assess the associations between gender and implant survival, as well as adverse local tissue reaction (ALTR), in patients with MoM THA. Secondly, we sought to report the differences between genders in metal ion levels and patient reported outcome measures (PROMs) in patients with MoM THA. Methods. The study population consisted of 729 ASR XL THA patients (820 hips) enrolled from September 2012 to June 2015 in a multicenter follow-up study at a mean of 6.4 (3–11) years from index surgery. The mean age at the time of index surgery was 60 (22–95) years and 338 were women (46%). All patients enrolled had complete patient and surgical demographic information, blood metal ion levels and PROMs obtained within 6 months, and a valid AP pelvis radiograph dating a maximum of 2 years prior to consent. Blood metal ion levels and PROMs were then obtained annually after enrollment. A sub-set of patients from a single center had annual metal artifact reduction sequence (MARS) MRI performed and were analyzed for the presence of moderate-to-severe ALTR. Results. Eighty-nine hips (11%) were revised during the study period. Forty-five of the 338 men underwent revision (13%), and 44 of the 391 women underwent revision (11%). The mean time from index surgery to revision was 7 years for both males and females. After controlling for confounding variables, the only variables found to be associated with revision surgery in patients with unilateral THA were VAS pain (hazard ratio [HR], 1.28; p < 0.001) and elevated cobalt metal ion levels (HR, 1.02; p < 0.001). Patients with bilateral arthroplasties with low HHS (HR, 0.96; p < 0.001) and high cobalt levels (HR, 1.02; p < 0.001) were at increased risk for revision. Moderate-to-severe ALTRs were identified in 48 of the 133 hips with