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OBJECTIVE: To investigate the long-term survivorship, incidence of adverse reactions to metal debris (ARMD), and metal ion behavior in patients who underwent small-head Metasul metal-on-metal (MoM) total hip arthroplasty (THA). METHODS: Between February 1998 and September 2003, a retrospective study was performed on 43 consecutive patients (43 hips) who underwent unilateral cementless Metasul MoM THAs at our institution. Of them, 35 patients (nine males and 26 females) who were available for follow-up more than 15 years after THA were enrolled in this study and underwent metal artifact reduction sequence magnetic resonance imaging (MARS-MRI) to identify ARMD. The mean age at surgery of the patients was 59.7 years old (range, 31-83). Clinical and radiographic outcomes were evaluated retrospectively. Clinical examinations were conducted using the Harris Hip Score (HHS). Serum cobalt (Co) and chromium (Cr) ion levels and Co/Cr ratio were assessed at different postoperative periods of <5, 5-10, 11-14, and ≥15 years. RESULTS: The mean follow-up period for the 35 patients included was 18.1 years (range, 15-22). The mean HHS significantly improved from 44.6 ± 11.3 points preoperatively to 89.4 ± 7.9 points at the final follow-up (P < 0.0001). ARMD was found in 20% of the patients using MARS-MRI. No signs of stem loosening were found clinically or radiographically, whereas cup loosening and ARMD were observed in three patients (9%), for whom revision THAs were performed. The Kaplan-Meier survival rates with revision for any reason as the endpoint were 90.9% at 5 years, 84.8% at 10 years, 84.8% at 15 years (95% CI, 67.1-93.6), and 70.3% at 20 years (95% CI, 43.6-87.0). The survival rates with revision for ARMD as the endpoint were 100% at 5 years, 96.6% at 10 years, 96.6% at 15 years (95% CI, 77.2-99.7), and 80.1% at 20 years (95% CI, 45.3-95.2). Serum Co ion level peaked at 5-10 years after THA, which was significantly higher than that <5 years; however, it decreased to the initial level after 15 years. In contrast, serum Cr ion level significantly increased at 5-10 years and then remained almost constant. Significant differences in Cr ion levels (1.0 vs 2.0 µg/L, P = 0.024) and Co/Cr ratio (1.3 vs 0.9, P = 0.037) were found between non-ARMD and ARMD patients at >11 years postoperatively. CONCLUSION: Our results suggest that increased Cr ion levels and decreased Co/Cr ratio may be signs of ARMD in patients who underwent small-head Metasul MoM THA.
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Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Prótesis Articulares de Metal sobre Metal , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Cadera/métodos , Cobalto , Femenino , Estudios de Seguimiento , Prótesis de Cadera/efectos adversos , Humanos , Masculino , Prótesis Articulares de Metal sobre Metal/efectos adversos , Persona de Mediana Edad , Diseño de Prótesis , Falla de Prótesis , Reoperación , Estudios RetrospectivosRESUMEN
BACKGROUND: National and international guidelines lack consistency on how to screen metal-on-metal (MoM) hip arthroplasty patients for adverse reactions to metal debris (ARMD). Long-term outcomes of MoM hip arthroplasty are scarce, hindering further development of such guidelines. We present the clinical, radiological and ARMD status of 158 cases of hip resurfacing with >10 years follow-up. METHODS: A prospective analysis of a cohort of 298 consecutive hip resurfacing procedures was performed at a single institution. All patients underwent MARS-MRI scanning for pseudotumour screening at least once, regardless of symptoms. Implant survival and reasons for revision were analysed for all patients. Clinical, radiological and MARS-MRI results were analysed for 158 unrevised procedures with >10 years follow-up. RESULTS: The implant survival was 85.9% at 14.5 years (95% CI, 81.9-90.6) with revision for all causes as endpoint and 92.3% with MoM disease-related revisions excluded (95% CI, 88.2-95.0). Of the 158 cases with >10 years follow-up, 1 had elevated metal ion levels, 29 had a stable C1 pseudotumour and 6 a stable C2 pseudotumour. All pseudotumours were observed within 3 years after initiating our intensified ARMD screening (2011), with no new pseudotumours observed after that period. CONCLUSIONS: We suggest that follow-up of MoM hip resurfacing patients beyond 10 years after surgery can be done with large intervals (i.e. every 5 years), and only earlier if a patient becomes symptomatic.
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Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Prótesis Articulares de Metal sobre Metal , Artroplastia de Reemplazo de Cadera/efectos adversos , Estudios de Seguimiento , Prótesis de Cadera/efectos adversos , Humanos , Prótesis Articulares de Metal sobre Metal/efectos adversos , Diseño de Prótesis , Falla de Prótesis , Reoperación , Estudios RetrospectivosRESUMEN
BACKGROUND: Adverse reactions to metal debris are significant complications after metal-on-metal total hip arthroplasty. Recently, late appearances of adverse reactions to metal debris and subsequent need for reoperations have been reported with small-diameter head metal-on-metal devices. We retrospectively investigated mid-term clinical outcomes of small-head metal-on-metal total hip arthroplasty. METHODS: We reviewed 159 hips in 139 patients who had a small-head metal-on-metal total hip arthroplasty (M2a Taper; Biomet, Warsaw, IN) with a minimum 5-year follow-up and documented postoperative complications. RESULTS: Focal osteolysis in either the femur or acetabulum was observed in 12 hips (7.5%, 44 months after surgery on average), with pseudotumor observed in 8 hips (5%, 120 months after surgery on average). Four hips (2.5%) had dislocations (84 months after surgery on average) and six hips (3.8%, 122 months after surgery on average) underwent reoperation. CONCLUSION: Small-head metal-on-metal total hip arthroplasty is associated with a high degree of complications at mid-term follow-up period. Considering this, we discourage the use of metal-on-metal total hip arthroplasty regardless of head size.
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The failure of total hip arthroplasty (THA) is commonly associated with the necrosis of the periprosthetic tissue. To date, there is no established method to noninvasively quantify the progression of such necrosis. Magnetic resonance imaging (MRI) of soft tissues near implants has undergone a recent renaissance due to the development of multispectral metal-artifact reduction techniques. Advanced analysis of multispectral MRI has been shown capable of detecting small magnetism effects of metallic debris in periprosthetic tissue. The purpose of this study is to demonstrate the diagnostic utility of these MRI-based tissue-magnetism signatures. Together with morphological MRI metrics, such as synovial volume and thickness, these measurements are utilized as biomarkers to noninvasively detect soft-tissue necrosis in symptomatic THA patients ( N=78 ). All subjects underwent an advanced MRI scan before revision surgery and tissue biopsies utilized for necrosis grading. Statistical analyses demonstrated a weak, but significant positive correlation (P = .04) between MRI magnetism signatures and necrosis scores, while indicating no meaningful association between the latter and serum cobalt and chromium ion levels. Receiver-operating characteristic (ROC) analyses were then performed based on uni- and multivariate logistic regression models utilizing the measured MRI biomarkers as predictors of severe necrosis. The area under the curve of the ROC plots for MRI biomarkers as combined predictors were found to be 0.70 and 0.84 for cross-validation and precision-recall tests, respectively.
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Puntos Anatómicos de Referencia , Articulación de la Cadera/diagnóstico por imagen , Prótesis de Cadera/efectos adversos , Imagen por Resonancia Magnética , Complicaciones Posoperatorias/diagnóstico por imagen , Anciano , Anciano de 80 o más Años , Artroplastia de Reemplazo de Cadera , Estudios de Factibilidad , Femenino , Articulación de la Cadera/patología , Humanos , Masculino , Persona de Mediana Edad , Necrosis , Complicaciones Posoperatorias/etiologíaRESUMEN
BACKGROUND: Modular stems are useful for total hip arthroplasty (THA) in anatomically difficult dysplasia. Here, we present mean 6.8-year outcomes of cementless primary THA using S-ROM-A (modified modular stem for Asian patients) femoral prosthesis in anatomically difficult cases. METHODS: Charts of 373 patients (461 hips) undergoing THA (mean age, 58 years) were reviewed for clinical evaluation of modified Merle d'Aubigné-Postel score and Kaplan-Meier survivorship with revision for any reason as the end point. For radiographic analysis, 331 patients (412 hips) followed up for ≥5 years were included. Bearing couples were metal-on-metal (n = 145), metal-on-polyethylene (n = 120), and ceramic-on-polyethylene (n = 147). Radiography and multiplanar computed tomography were performed. RESULTS: No postoperative dislocation or deep infection occurred. Mean modified Merle d'Aubigné-Postel score improved significantly (10.9 points preoperatively, 16.7 points at last follow-up; P < .001). Cumulative 5- and 10-year stem survival rates were 100% and 84%, respectively (95% confidence interval, 75%-93%). All stems were classified as bone ingrown fixation. Osteolysis occurred in metal-on-metal (42.8%) and metal-on-polyethylene (15.8%) groups. Mean time to osteolysis was ~3 years, with no significant difference between 3 groups (P = .264). In logistic regression, lower cup inclination angle was significantly associated with osteolysis (odds ratio, 0.914; 95% confidence interval, 0.84-0.99; P = .029). CONCLUSION: S-ROM-A femoral prosthesis achieved excellent midterm fixation, and the modular system was useful in primary THA with severe deformity. Bearing couples are potentially associated with adverse reactions to metal debris. S-ROM-A with ceramic-on-polyethylene bearing couples may be an option for anatomically difficult THA.
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Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Osteólisis , Pueblo Asiatico , Estudios de Seguimiento , Articulación de la Cadera/cirugía , Humanos , Persona de Mediana Edad , Osteólisis/cirugía , Diseño de Prótesis , Falla de Prótesis , Reoperación , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Surgeons currently have difficulty when managing metal-on-metal hip arthroplasty (MoMHA) patients with adverse reactions to metal debris (ARMD). This stems from a lack of evidence, which is emphasized by the variability in the recommendations proposed by different worldwide regulatory authorities for considering MoMHA revision surgery. We investigated predictors of poor outcomes following MoMHA revision surgery performed for ARMD to help inform the revision threshold and type of reconstruction. METHODS: We retrospectively studied 346 MoMHA revisions for ARMD performed at 2 European centers. Preoperative (metal ions/imaging) and intraoperative (findings, components removed/implanted) factors were used to predict poor outcomes. Poor outcomes were postoperative complications (including re-revision), 90-day mortality, and poor Oxford Hip Score. RESULTS: Poor outcomes occurred in 38.5%. Shorter time (under 4 years) to revision surgery was the only preoperative predictor of poor outcomes (odds ratio [OR] = 2.12, confidence interval [CI] = 1.00-4.46). Prerevision metal ions and imaging did not influence outcomes. Single-component revisions (vs all-component revisions) increased the risk of poor outcomes (OR = 2.99, CI = 1.50-5.97). Intraoperative modifiable factors reducing the risk of poor outcomes included the posterior approach (OR = 0.22, CI = 0.10-0.49), revision head sizes ≥36 mm (vs <36 mm: OR = 0.37, CI = 0.18-0.77), ceramic-on-polyethylene revision bearings (OR vs ceramic-on-ceramic = 0.30, CI = 0.14-0.66), and metal-on-polyethylene revision bearings (OR vs ceramic-on-ceramic = 0.37, CI = 0.17-0.83). CONCLUSION: No threshold exists for recommending revision in MoMHA patients with ARMD. However postrevision outcomes were surgeon modifiable. Optimal outcomes may be achieved if surgeons use the posterior approach, revise all MoMHA components, and use ≥36 mm ceramic-on-polyethylene or metal-on-polyethylene articulations.
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Artroplastia de Reemplazo de Cadera/estadística & datos numéricos , Prótesis de Cadera/efectos adversos , Prótesis Articulares de Metal sobre Metal/efectos adversos , Complicaciones Posoperatorias/cirugía , Reoperación/estadística & datos numéricos , Anciano , Cerámica , Femenino , Humanos , Modelos Logísticos , Masculino , Metales/efectos adversos , Persona de Mediana Edad , Oportunidad Relativa , Polietileno , Complicaciones Posoperatorias/etiología , Diseño de Prótesis , Estudios RetrospectivosRESUMEN
Metal-on-metal (MoM) bearings in total hip arthroplasties and hip resurfacing arthroplasties have recently shown a new type of complication: adverse reactions to metal debris (ARMD). ARMD is characterized by local severe inflammation and tissue necrosis leading to implant failures. The gluteal muscle region is important for the patient outcome after revision surgery. This prospective positron emission tomography/computed tomography (PET/CT) study was undertaken to evaluate the characteristics of 2-deoxy-2-[18 F]fluoro-d-glucose ([18 F]FDG) and [68 Ga]Gallium citrate ([68 Ga]Citrate) PET/CT in ARMD patients. [18 F]FDG and [68 Ga]Citrate PET/CT were performed in 18 hip arthroplasty patients: 12 ARMD patients (with 16 MoM hips) and six arthroplasty controls without ARMD. Tracer uptake was evaluated visually, and maximum standardized uptake (SUVmax ) was measured in the gluteal muscle region. ARMD severity was graded by metal artefact reduction sequence-magnetic resonance imaging (MARS-MRI). Periprosthetic [18 F]FDG uptake was observed in 15 of 16 hips, [68 Ga]Citrate uptake in three of 16 hips, respectively. The distribution of tracer uptake resembled infection in three hips. In the gluteal muscle region, the SUVmax of [18 F]FDG was significantly greater in hips with moderate and severe ARMD compared with the controls (P = 0·009 for [18 F]FDG and P = 0·217 for [68 Ga]Citrate). In patients who needed revision surgery, an intraoperative finding of gluteal muscle necrosis was associated with increased local SUVmax as detected by preoperative [18 F]FDG (P = 0·039), but not by [68 Ga]Citrate (P = 0·301). In conclusion, the inflammatory reaction to metal debris in hip arthroplasty patients is best visualized with [18 F]FDG.
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Artroplastia de Reemplazo de Cadera/instrumentación , Reacción a Cuerpo Extraño/diagnóstico por imagen , Articulación de la Cadera/diagnóstico por imagen , Articulación de la Cadera/cirugía , Prótesis de Cadera , Prótesis Articulares de Metal sobre Metal , Músculo Esquelético/diagnóstico por imagen , Tomografía Computarizada por Tomografía de Emisión de Positrones , Anciano , Artroplastia de Reemplazo de Cadera/efectos adversos , Nalgas , Citratos/administración & dosificación , Femenino , Fluorodesoxiglucosa F18/administración & dosificación , Reacción a Cuerpo Extraño/etiología , Reacción a Cuerpo Extraño/cirugía , Galio/administración & dosificación , Articulación de la Cadera/patología , Humanos , Imagen por Resonancia Magnética , Masculino , Persona de Mediana Edad , Músculo Esquelético/patología , Músculo Esquelético/cirugía , Necrosis , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , Radiofármacos/administración & dosificación , Reoperación , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
AIMS: To determine the outcomes following revision surgery of metal-on-metal hip arthroplasties (MoMHA) performed for adverse reactions to metal debris (ARMD), and to identify factors predictive of re-revision. PATIENTS AND METHODS: We performed a retrospective observational study using National Joint Registry (NJR) data on 2535 MoMHAs undergoing revision surgery for ARMD between 2008 and 2014. The outcomes studied following revision were intra-operative complications, mortality and re-revision surgery. Predictors of re-revision were identified using competing-risk regression modelling. RESULTS: Intra-operative complications occurred in 40 revisions (1.6%). The cumulative five-year patient survival rate was 95.9% (95% confidence intervals (CI) 92.3 to 97.8). Re-revision surgery was performed in 192 hips (7.6%). The cumulative five-year implant survival rate was 89.5% (95% CI 87.3 to 91.3). Predictors of re-revision were high body mass index at revision (subhazard ratio (SHR) 1.06 per kg/m2 increase, 95% CI 1.02 to 1.09), modular component only revisions (head and liner with or without taper adapter; SHR 2.01, 95% CI 1.19 to 3.38), ceramic-on-ceramic revision bearings (SHR 1.86, 95% CI 1.23 to 2.80), and acetabular bone grafting (SHR 2.10, 95% CI 1.43 to 3.07). These four factors remained predictive of re-revision when the missing data were imputed. CONCLUSION: The short-term risk of re-revision following MoMHA revision surgery performed for ARMD was comparable with that reported in the NJR following all-cause non-MoMHA revision surgery. However, the factors predictive of re-revision included those which could be modified by the surgeon, suggesting that rates of failure following ARMD revision may be reduced further. Cite this article: Bone Joint J 2017;99-B:1020-7.
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Artroplastia de Reemplazo de Cadera/efectos adversos , Reacción a Cuerpo Extraño/cirugía , Prótesis de Cadera/efectos adversos , Prótesis Articulares de Metal sobre Metal/efectos adversos , Sistema de Registros , Inglaterra/epidemiología , Femenino , Reacción a Cuerpo Extraño/epidemiología , Reacción a Cuerpo Extraño/etiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Diseño de Prótesis , Falla de Prótesis , Reoperación , Estudios Retrospectivos , Factores de Riesgo , Resultado del Tratamiento , Gales/epidemiologíaRESUMEN
OBJECTIVES: Few studies have assessed outcomes following non-metal-on-metal hip arthroplasty (non-MoMHA) revision surgery performed for adverse reactions to metal debris (ARMD). We assessed outcomes following non-MoMHA revision surgery performed for ARMD, and identified predictors of re-revision. METHODS: We performed a retrospective observational study using data from the National Joint Registry for England and Wales. All non-MoMHAs undergoing revision surgery for ARMD between 2008 and 2014 were included (185 hips in 185 patients). Outcome measures following ARMD revision were intra-operative complications, mortality and re-revision surgery. Predictors of re-revision were identified using Cox regression. RESULTS: Intra-operative complications occurred in 6.0% (n = 11) of the 185 cases. The cumulative four-year patient survival rate was 98.2% (95% CI 92.9 to 99.5). Re-revision surgery was performed in 13.5% (n = 25) of hips at a mean time of 1.2 years (0.1 to 3.1 years) following ARMD revision. Infection (32%; n = 8), dislocation/subluxation (24%; n = 6), and aseptic loosening (24%; n = 6) were the most common re-revision indications. The cumulative four-year implant survival rate was 83.8% (95% CI 76.7 to 88.9). Multivariable analysis identified three predictors of re-revision: multiple revision indications (hazard ratio (HR) = 2.78; 95% CI 1.03 to 7.49; p = 0.043); selective component revisions (HR = 5.76; 95% CI 1.28 to 25.9; p = 0.022); and ceramic-on-polyethylene revision bearings (HR = 3.08; 95% CI 1.01 to 9.36; p = 0.047). CONCLUSIONS: Non-MoMHAs revised for ARMD have a high short-term risk of re-revision, with important predictors of future re-revision including selective component revision, multiple revision indications, and ceramic-on-polyethylene revision bearings. Our findings may help counsel patients about the risks of ARMD revision, and guide reconstructive decisions. Future studies attempting to validate the predictors identified should also assess the effects of implant design (metallurgy and modularity), given that this was an important study limitation potentially influencing the reported prognostic factors.Cite this article: G. S. Matharu, A. Judge, D. W. Murray, H. G. Pandit. Outcomes following revision surgery performed for adverse reactions to metal debris in non-metal-on-metal hip arthroplasty patients: Analysis of 185 revisions from the National Joint Registry for England and Wales. Bone Joint Res 2017;6:405-413. DOI: 10.1302/2046-3758.67.BJR-2017-0017.R2.
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AIMS: To determine ten-year failure rates following 36 mm metal-on-metal (MoM) Pinnacle total hip arthroplasty (THA), and identify predictors of failure. PATIENTS AND METHODS: We retrospectively assessed a single-centre cohort of 569 primary 36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012 according to Medicines and Healthcare Products Regulation Agency recommendations. All-cause failure rates (all-cause revision, and non-revised cross-sectional imaging failures) were calculated, with predictors for failure identified using multivariable Cox regression. RESULTS: Failure occurred in 97 hips (17.0%). The ten-year cumulative failure rate was 27.1% (95% confidence interval (CI) 21.6 to 33.7). Primary implantation from 2006 onwards (hazard ratio (HR) 4.30; 95% CI 1.82 to 10.1; p = 0.001) and bilateral MoM hip arthroplasty (HR 1.59; 95% CI 1.03 to 2.46; p = 0.037) predicted failure. The effect of implantation year on failure varied over time. From four years onwards following surgery, hips implanted since 2006 had significantly higher failure rates (eight years 28.3%; 95% CI 23.1 to 34.5) compared with hips implanted before 2006 (eight years 6.3%; 95% CI 2.4 to 15.8) (HR 15.2; 95% CI 2.11 to 110.4; p = 0.007). CONCLUSION: We observed that 36 mm MoM Pinnacle THAs have an unacceptably high ten-year failure rate, especially if implanted from 2006 onwards or in bilateral MoM hip patients. Our findings regarding implantation year and failure support recent concerns about the device manufacturing process. We recommend all patients undergoing implantation since 2006 and those with bilateral MoM hips undergo regular investigation, regardless of symptoms. Cite this article: Bone Joint J 2017;99-B:592-600.
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Artroplastia de Reemplazo de Cadera/efectos adversos , Prótesis de Cadera/efectos adversos , Prótesis Articulares de Metal sobre Metal/efectos adversos , Falla de Prótesis/etiología , Adulto , Anciano , Anciano de 80 o más Años , Artroplastia de Reemplazo de Cadera/instrumentación , Artroplastia de Reemplazo de Cadera/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Diseño de Prótesis , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Factores de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Adverse reactions to metal debris (ARMD) have resulted in the high short-term failure rates observed with metal-on-metal hip replacements. ARMD has recently been reported in non-metal-on-metal total hip replacements (non-MoM THRs) in a number of small cohort studies. However the true magnitude of this complication in non-MoM THRs remains unknown. We used a nationwide database to determine the risk of ARMD revision in all non-MoM THRs, and compared patient and surgical factors associated with ARMD revision between non-MoM and MoM hips. METHODS: We performed a retrospective observational study using data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. All primary hip replacements undergoing revision surgery for ARMD were included (n = 3,340). ARMD revision risk in non-MoM THRs was compared between different commonly implanted bearing surfaces and femoral head sizes (Chi-squared test). Differences in patient and surgical factors between non-MoM hips and MoM hips revised for ARMD were also analysed (Chi-squared test and unpaired t-test). RESULTS: Of all ARMD revisions, 7.5% (n = 249) had non-MoM bearing surfaces. The relative risk of ARMD revision was 2.35 times (95% CI 1.76-3.11) higher in ceramic-on-ceramic bearings compared with hard-on-soft bearings (0.055 vs. 0.024%; p < 0.001), and 2.80 times (95% CI 1.74-4.36) higher in 36 mm metal-on-polyethylene bearings compared to 28 mm and 32 mm metal-on-polyethylene bearings (0.058 vs. 0.021%; p < 0.001). ARMD revisions were performed earlier in non-MoM hips compared to MoM hips (mean 3.6-years vs. 5.6-years; p < 0.0001). Non-MoM hips had more abnormal findings at revision (63.1 vs. 35.7%; p < 0.001), and more intra-operative adverse events (6.4 vs. 1.6%; p < 0.001) compared to MoM hips. CONCLUSIONS: Although the overall risk of ARMD revision surgery in non-MoM THRs appears low, this risk is increasing, and is significantly higher in ceramic-on-ceramic THRs and 36 mm metal-on-polyethylene THRs. ARMD may therefore represent a significant clinical problem in non-MoM THRs.
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Artroplastia de Reemplazo de Cadera/efectos adversos , Prótesis de Cadera/efectos adversos , Prótesis Articulares de Metal sobre Metal/efectos adversos , Metales/efectos adversos , Reoperación/estadística & datos numéricos , Anciano , Artroplastia de Reemplazo de Cadera/instrumentación , Cerámica , Inglaterra , Femenino , Humanos , Masculino , Persona de Mediana Edad , Irlanda del Norte , Polietileno , Diseño de Prótesis , Sistema de Registros , Estudios Retrospectivos , GalesRESUMEN
AIMS: We investigated whether blood metal ion levels could effectively identify patients with bilateral Birmingham Hip Resurfacing (BHR) implants who have adverse reactions to metal debris (ARMD). PATIENTS AND METHODS: Metal ion levels in whole blood were measured in 185 patients with bilateral BHRs. Patients were divided into those with ARMD who either had undergone a revision for ARMD or had ARMD on imaging (n = 30), and those without ARMD (n = 155). Receiver operating characteristic analysis was used to determine the optimal thresholds of blood metal ion levels for identifying patients with ARMD. RESULTS: The maximum level of cobalt or chromium ions in the blood was the parameter which produced the highest area under the curve (91.0%). The optimal threshold for distinguishing between patients with and without ARMD was 5.5 µg/l (83.3% sensitivity, 88.4% specificity, 58.1% positive and 96.5% negative predictive values). Similar results were obtained in a subgroup of 111 patients who all underwent cross-sectional imaging. Between 3.2% and 4.3% of patients with ARMD were missed if United Kingdom (7 µg/l) and United States (10 µg/l) authority thresholds were used respectively, compared with 2.7% if our implant specific threshold was used, though these differences did not reach statistical significance (p ≥ 0.248). CONCLUSION: Patients with bilateral BHRs who have blood metal ion levels below our implant specific threshold were at low-risk of having ARMD. Cite this article: Bone Joint J 2016;98-B:1455-62.
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Artroplastia de Reemplazo de Cadera/efectos adversos , Cromo/sangre , Cobalto/sangre , Cuerpos Extraños/sangre , Prótesis de Cadera/efectos adversos , Prótesis Articulares de Metal sobre Metal/efectos adversos , Adulto , Anciano , Artroplastia de Reemplazo de Cadera/instrumentación , Artroplastia de Reemplazo de Cadera/métodos , Biomarcadores/sangre , Femenino , Cuerpos Extraños/etiología , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Falla de Prótesis/etiología , Curva ROC , Reoperación , Sensibilidad y EspecificidadRESUMEN
Metal-on-metal (MoM) hip replacements, often manufactured from a cobalt-chrome alloy, are associated with adverse reactions including soft tissue necrosis and osteolysis. Histopathological analysis of MoM peri-implant tissues reveals an inflammatory cell infiltrate that includes macrophages, monocytes and neutrophils. Toll-like receptor 4 (TLR4) is an innate immune receptor activated by bacterial lipopolysaccharide. Recent studies have demonstrated that cobalt ions from metal-on-metal joints also activate human TLR4, increasing cellular secretion of inflammatory chemokines including interleukin-8 (IL-8, CXCL8) and CCL2. Chemokines recruit immune cells to the site of inflammation, and their overall effect depends on the chemokine profile produced. This study investigated the effect of cobalt on the secretion of inflammatory cytokines CCL20 and IL-6. The chemotactic potential of conditioned media from a cobalt-stimulated human monocyte cell line on primary monocytes and neutrophils was investigated using an in vitro transwell migration assay. The role of TLR4 in observed effects was studied using a small molecule TLR4-specific antagonist. Cobalt ions significantly increased release of CCL2 and IL-6 by MonoMac 6 cells (P<0.001). Conditioned media from cobalt-stimulated cells significantly increased monocyte and neutrophil chemotaxis in vitro (P<0.001). These effects were abrogated by the TLR4 antagonist (P<0.001) suggesting that they occur through cobalt activation of TLR4. This study demonstrates the role of TLR4 in cobalt-mediated immune cell chemotaxis and provides a potential mechanism by which cobalt ions may contribute to the immune cell infiltrate surrounding failed metal hip replacements. It also highlights the TLR4 signalling pathway as a potential therapeutic target in preventing cobalt-mediated inflammation.
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The diagnosis and treatment of patients with painful total hip arthroplasties secondary to taper corrosion and wear of modular junctions and metal-on-metal bearings represents a major challenge for the orthopaedic clinician. Guidelines are evolving as we analyze the growing body of evidence regarding metal-related failures of orthopaedic implants and adverse reactions to metal debris. In this article 6 case examples are presented to enhance understanding and application of current evidence into practice. Clinical expertise is integrated with the best available evidence from research and national joint registries data into the decision making process relevant for patient care in everyday practice. Issues addressed include understanding taper corrosion and metal failure mechanisms, clinical presentation of adverse soft tissue reactions, utility of specialized tests such as metal ion analysis and cross-sectional imaging studies, the utility of modular components for primary THA, dealing with recalled component, and current recommendations.