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1.
Hip Int ; 32(4): 493-500, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33445979

RESUMO

BACKGROUND: Many worldwide regulatory authorities recommend regular surveillance of metal-on-metal hip arthroplasty patients given high failure rates. However, concerns have been raised about whether such regular surveillance, which includes asymptomatic patients, is evidence-based and cost-effective. We determined: (1) the cost of implementing the 2015 MHRA surveillance in "at-risk" Birmingham Hip Resurfacing (BHR) patients; and (2) how many asymptomatic hips with adverse reactions to metal debris (ARMD) would have been missed without patient recall. METHODS: All BHR patients eligible for the 2015 MHRA recall (all females, and males with head sizes ⩽46 mm, regardless of symptoms) at one centre were invited for review (hips = 707; patients = 593). All patients were investigated (Oxford Hip Score, radiographs, blood metal ions, and targeted cross-sectional imaging) and managed accordingly. Surveillance costs were calculated using finance department data. RESULTS: The surveillance cost £105,921.79 (range £147.76-£257.50/patient). Radiographs (£39,598) and nurse practitioner time/assistance (£23,618) accounted for 60% of overall costs. 31 hips had ARMD on imaging (12 revised; 19 under surveillance). All revisions were symptomatic. 7 hips with ARMD under surveillance were asymptomatic and remain under regular review. The number needed to treat to avoid missing one asymptomatic ARMD case was 101 patients, representing a cost of £18,041 to avoid one asymptomatic case. CONCLUSIONS: Implementing MHRA surveillance for "at-risk" BHR patients was extremely costly. The risk of asymptomatic ARMD was low with the BHR (1%), suggesting recommended follow-up in asymptomatic patients is not cost efficient. This raises concerns about the increasingly intensive surveillance recommended in the 2017 MHRA guidance for metal-on-metal hip patients.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Próteses Articulares Metal-Metal , Artroplastia de Quadril/efeitos adversos , Atenção à Saúde , Feminino , Prótese de Quadril/efeitos adversos , Humanos , Masculino , Próteses Articulares Metal-Metal/efeitos adversos , Metais/efeitos adversos , Desenho de Prótese , Falha de Prótese , Reoperação
2.
Hip Int ; 30(2_suppl): 42-51, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-33267695

RESUMO

INTRODUCTION: There is limited knowledge of the long-term results of metal-on-metal total hip arthroplasty (MoM THA), particularly concerning adverse local tissue reaction (ALTR), Co/Cr ions level and revision rate. Even if MoM bearing surfaces are no longer used, long-term data could help in defining the course and best management for these patients. The purpose of this study is to investigate the clinical outcomes, describe radiological findings including CT metal artefact reduction algorithm for orthopaedic implants (O-MAR) and MRI multi acquisition variable resonance image combination (MAVRIC) in 36-mm MoM THA. METHODS: In this long-term prospective study, 46 consecutive patients with primary MoM THA (mono- or bilateral) were enrolled between 2004 and 2005. Pinnacle acetabular cup, Summit cementless stem with 36-mm metal head and Ultamet CoCr alloy liner (Depuy Inc.) were implanted, in the same centre by the same senior surgeon. Patients were reviewed at 5-, 10- and 15-years, including Co/Cr levels and standard radiographs at every follow-up, whilst the 15-year follow-up included hip sonography, MRI MAVRIC and CT O-MAR. RESULTS: At 15 years, the overall survival rate of the implants (both stems and cups) was 83% (30/36). Revisions were performed in 9% (4/46) because of ALTR, 2% (1/46) septic loosening and 2% periprosthetic fracture. Both Cr and Co concentration increased over time, even though remaining at low level risk at 15 years: Co from 0.11 (+/- 0.18) to 4.29 (+/- 3.26) and Cr from 0.38 (+/- 0.32) to 1.37 (+/- 1.15). Functional scores in non-revised patients showed good to excellent results in more than 90%. Engh-score correlated with time from surgery (p = 0.017) and with sonographic, CT and RM findings (p < 0.05). Concordance has been found between CT and MRI findings (sign-rank test, p = 0.241; Intraclass Correlation Coefficients 0.987); however, no specific MRI or CT lesion patterns could be recognised among symptomatic and non-symptomatic patients. DISCUSSION: The long-term rate of ALTR after 36-mm MoM THA was comparable with previous studies; a regular follow-up for those implants is mandatory. During follow-up Co-Cr levels increased over time and radiography was a suitable screening technique; the Engh score in particular, proved to be a reliable assessment tool. CT O-MAR and MRI with MAVRIC protocols may add valuable data in clinical practice, although MRI is significantly more efficient than CT in the identification of ALTR lesions, peri-articular effusion and in the evaluation of soft tissues.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Próteses Articulares Metal-Metal , Artroplastia de Quadril/efeitos adversos , Seguimentos , Humanos , Laboratórios , Imageamento por Ressonância Magnética , Próteses Articulares Metal-Metal/efeitos adversos , Estudos Prospectivos , Desenho de Prótese , Falha de Prótese , Radiografia , Reoperação , Tomografia Computadorizada por Raios X
3.
Int Orthop ; 44(10): 1943-1949, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32642825

RESUMO

PURPOSE: Metal-on-metal (MOM) bearings may carry higher than expected revision rates and serious complications: an appropriate surveillance may be advocated. Aims of this paper were to (1) present the biennial experience of MOM surveillance in a tertiary centre, (2) describe the patients' adherence to monitoring, and (3) analyze the costs of the surveillance METHODS: The design of MOM surveillance was developed according to the guidelines of the Italian Society of Orthopaedics and Traumatology. The adherence to every follow-up was expressed as raw numbers and percentages. A cost analysis (direct and indirect costs) was conducted and projected in a five year time span. RESULTS: About 61.1% of patients adhered to the first step of the surveillance, and 13.5% answered to a specific questionnaire about MOM implant. About 36.2% of the patients participated for the annual follow-up, and 18.1% entered the six month follow-up program. Of the implants, 2.5% required a revision. A two year surveillance costs €45,520.30, €236,443.98 (57.7%) including revisions. Five-year projected costs will be €23.113,64 (5.6%). Hospital indirect costs, including personnel working days, were €150,392.30 (36.7%). The estimated economic burden for seven years will be €409,949.92 (direct € 259,557.62, indirect €150,392.30). CONCLUSION: Patients' adherence to MOM surveillance is modest and the rate of dropouts seems not to stop over the time. Most of the expenses are due to revision surgeries, as well as indirect costs. Economy of scale may be suggested to reduce the costs, involving as much MOM population as possible.


Assuntos
Artroplastia de Quadril , Prótese de Quadril , Próteses Articulares Metal-Metal , Artroplastia de Quadril/efeitos adversos , Custos e Análise de Custo , Prótese de Quadril/efeitos adversos , Humanos , Polietileno , Desenho de Prótese , Falha de Prótese , Reoperação , Fatores de Risco
4.
BMJ ; 366: l4230, 2019 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-31266745

RESUMO

The studyFawsitt C, Thom H, Hunt L. Choice of prosthetic implant combinations in total hip replacement: cost-effectiveness analysis using UK and Swedish hip joint registries data. Value Health 2019;22:303-12.This study was funded by the NIHR Research for Patient Benefit Programme (project number PB-PG-0613-31032).To read the full NIHR Signal, go to https://discover.dc.nihr.ac.uk/content/signal-000771/a-traditional-hip-implant-is-as-effective-as-more-expensive-newer-types-for-older-people.


Assuntos
Artroplastia de Quadril , Desenho de Equipamento , Prótese de Quadril , Complicações Pós-Operatórias , Reoperação , Idoso , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/instrumentação , Artroplastia de Quadril/métodos , Cerâmica/uso terapêutico , Análise Custo-Benefício , Desenho de Equipamento/métodos , Desenho de Equipamento/normas , Feminino , Prótese de Quadril/classificação , Prótese de Quadril/normas , Humanos , Masculino , Próteses Articulares Metal-Metal , Osteoartrite do Quadril/cirurgia , Avaliação de Resultados em Cuidados de Saúde , Polietileno/uso terapêutico , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Falha de Prótese/efeitos adversos , Reoperação/métodos , Reoperação/estatística & dados numéricos , Reino Unido
5.
J Arthroplasty ; 33(6): 1826-1832, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29510952

RESUMO

BACKGROUND: The use of metal-on-metal (MoM) hip bearings has declined in the recent years due to strong evidence of their high complication rates and early failure. Hip implants with highly cross-linked polyethylene liners and ceramic bearings have become the modern implants of choice. We sought to determine if MoM implants are associated with higher complication and revision rates when compared to other hip bearings in the Medicare population. METHODS: We retrospectively reviewed a Medicare database (2005-2011) for patients who underwent a primary total hip arthroplasty with a MoM, metal-on-polyethylene (MoP), ceramic-on-polyethylene (CoP), or ceramic-on-ceramic (CoC) implant (minimum 2 years of follow-up). Patient comorbidities and medical/surgical complication rates were analyzed at various time points postoperatively. RESULTS: We identified 288,118 patients, including 81,520 patients with a MoM implant, 162,881 with MoP, 33,819 with CoP, and 9898 with CoC implant. Surgical complication rates were higher for MoM implants including infection, osteolysis/polywear, mechanical complications, and need for hip irrigation and debridement. Overall revision rates were significantly higher for MoM implants (5.28%) compared to MoP (4.28%, odds ratio [OR] 1.26, P < .001) and CoP (3.52%, OR 1.55, P < .001) but only by one to two percent. MoM revision rates were similar to CoC implants (4.94%, OR 1.00, P = .096). CONCLUSIONS: MoM implants were associated with higher revision rates (5.28%) compared to MoP (4.28%) and CoP (3.52%) implants in the Medicare population. Both complication and revision rates were comparable to CoC implants.


Assuntos
Artroplastia de Quadril/instrumentação , Prótese de Quadril/efeitos adversos , Próteses Articulares Metal-Metal/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Reoperação/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Cerâmica , Bases de Dados Factuais , Feminino , Prótese de Quadril/estatística & dados numéricos , Humanos , Masculino , Medicare , Próteses Articulares Metal-Metal/estatística & dados numéricos , Metais , Pessoa de Meia-Idade , Razão de Chances , Polietileno , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Estudos Retrospectivos , Fatores de Risco , Estados Unidos/epidemiologia
6.
Health Policy ; 122(5): 548-557, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29598886

RESUMO

The general shortage of evidence regarding benefits and harms of medical devices has been highlighted following the serious safety concerns with metal-on-metal hip replacements and silicone breast implants and was again pointed out in a recent survey of European Health Technology Assessment institutions. In this context the new European medical device regulation will enforce post-marketing surveillance of existing and new implants. The usefulness of registry data as a source of information for medical device real-world clinical performance and safety has been demonstrated. However, these data might be under-used by researchers and policy makers. One reason for this is the insufficient awareness of their existence. The aim of this review is to provide information to relevant stakeholders on the extent and breadth of the data currently collected in European joint replacement registries. We identified 24 registries, most of them of national coverage. Total numbers of primary total hip and knee replacements included were over 3.1 and 2.5 million records, respectively. The current focus of these registries is on whole-lifespan implant surveillance via revision rate monitoring, quality assessment of surgical and perioperative care, and hospital performance assessment. More recently, national and international comparison and benchmarking have increasingly become part of their endeavors.


Assuntos
Artroplastia de Quadril , Artroplastia do Joelho , Sistema de Registros , Avaliação da Tecnologia Biomédica , Europa (Continente) , Humanos , Próteses Articulares Metal-Metal/estatística & dados numéricos
8.
J Arthroplasty ; 32(4): 1206-1210, 2017 04.
Artigo em Inglês | MEDLINE | ID: mdl-27988181

RESUMO

BACKGROUND: Total hip arthroplasty with metal-on-metal (MoM) bearings has been suspected to cause adverse reactions to metal debris (ARMD), with the incidence varying greatly by implant type and patient gender. The prevalence of ARMD from small-diameter MoM bearings in women is unknown, especially after 10 years of follow-up (FU). METHODS: Cementless 28-mm MoM total hip arthroplasty bearings (Metasul) were implanted consecutively in 42 active women between 1996 and 2002. They were reviewed after a minimum of 10 years' FU with clinical, laboratory, radiological, and ultrasound assessments. RESULTS: Mean FU was 15.9 years (range, 13-18). The mean Postel-Merle d'Aubigné and Oxford scores were 16.9 (range, 13-18) and 15.1 (range, 12-24), respectively, at FU. Mean cup inclination angle was 46.3° (range, 35°-57°). No femoral osteolysis was detected, but limited acetabular osteolysis (11%) over the screw holes occurred in 5 cases. No liquid or solid synovial reactions or ARMD were apparent on ultrasound, even in the 5 cases of pelvic osteolysis. Mean chromium levels were 1.32 µg/L (range, 0.1-7.9) and cobalt levels were 1.85 µg/L (range, 0.35-13.6). Cobalt was >3 µg/L in only 3 cases. The 15.9-year survivorship was 95% (range, 94.1%-98.9%). CONCLUSION: Reliable results were obtained with 28-mm MoM bearings, notably in young, active patients. This implant configuration requires very accurate positioning. No ARMD was seen in this group at 16 years' FU.


Assuntos
Prótese de Quadril/efeitos adversos , Próteses Articulares Metal-Metal/efeitos adversos , Metais/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Acetábulo/cirurgia , Adolescente , Adulto , Artroplastia de Quadril/efeitos adversos , Cromo/sangue , Cobalto/sangue , Feminino , Fêmur/cirurgia , Seguimentos , Humanos , Incidência , Pessoa de Meia-Idade , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/diagnóstico por imagem , Complicações Pós-Operatórias/etiologia , Prevalência , Desenho de Prótese , Radiografia , Reoperação , Estudos Retrospectivos , Taxa de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia , Adulto Jovem
9.
PLoS One ; 11(11): e0165021, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27802289

RESUMO

BACKGROUND: Total hip replacement for end stage arthritis of the hip is currently the most common elective surgical procedure. In 2007 about 7.5% of UK implants were metal-on-metal joint resurfacing (MoM RS) procedures. Due to poor revision performance and concerns about metal debris, the use of RS had declined by 2012 to about a 1% share of UK hip procedures. This study estimated the lifetime cost-effectiveness of metal-on-metal resurfacing (RS) procedures versus commonly employed total hip replacement (THR) methods. METHODOLOGY/PRINCIPAL FINDINGS: We performed a cost-utility analysis using a well-established multi-state semi-Markov model from an NHS and personal and social services perspective. We used individual patient data (IPD) from the National Joint Registry (NJR) for England and Wales on RS and THR surgery for osteoarthritis recorded from April 2003 to December 2012. We used flexible parametric modelling of NJR RS data to guide identification of patient subgroups and RS devices which delivered revision rates within the NICE 5% revision rate benchmark at 10 years. RS procedures overall have an estimated revision rate of 13% at 10 years, compared to <4% for most THR devices. New NICE guidance now recommends a revision rate benchmark of <5% at 10 years. 60% of RS implants in men and 2% in women were predicted to be within the revision benchmark. RS devices satisfying the 5% benchmark were unlikely to be cost-effective compared to THR at a standard UK willingness to pay of £20,000 per quality-adjusted life-year. However, the probability of cost effectiveness was sensitive to small changes in the costs of devices or in quality of life or revision rate estimates. CONCLUSION/SIGNIFICANCE: Our results imply that in most cases RS has not been a cost-effective resource and should probably not be adopted by decision makers concerned with the cost effectiveness of hip replacement, or by patients concerned about the likelihood of revision, regardless of patient age or gender.


Assuntos
Análise Custo-Benefício/economia , Pessoal de Saúde/economia , Próteses Articulares Metal-Metal/economia , Adulto , Idoso , Artroplastia de Quadril/economia , Artroplastia de Quadril/métodos , Inglaterra , Feminino , Prótese de Quadril/economia , Humanos , Masculino , Metais , Pessoa de Meia-Idade , Osteoartrite do Quadril/cirurgia , Osteoartrite do Quadril/terapia , Desenho de Prótese/economia , Desenho de Prótese/métodos , Falha de Prótese , Qualidade de Vida , Sistema de Registros , Fatores de Risco , País de Gales
11.
J Arthroplasty ; 31(9 Suppl): 233-236.e1, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27118351

RESUMO

BACKGROUND: Isolated case reports in the literature describe systemic neurologic side effects associated with metal-on-metal (MOM) bearing surfaces, yet the incidence of these effects have not been evaluated beyond individual cases. The purpose of this study was to compare new diagnoses of these side effects described in isolated cases in large patient cohorts of MOM vs metal on polyethylene (MOP). METHODS: We queried the entire Medicare database from 2005 to 2012. Total hip arthroplasty (THA) and bearing surface were determined using International Classification of Diseases, 9th revision procedure codes. Patients with 5-year follow-up were selected. Using International Classification of Diseases, 9th revision codes, we identified new diagnoses of previously reported neurologic side effects: peripheral neuropathy, sensorineural hearing loss, visual impairment, paresthesias, tinnitus, and vertigo. Comorbidities and demographics were collected. Odds ratios, CIs, and P values were calculated. RESULTS: Overall, 29,483 MOM THAs and 23,587 age- and gender-matched MOP THAs were identified. The average Charlson Comorbidity Index was 5 for both groups. MOM and MOP patients had 26 of 30 identical prevalence of Elixhauser-measure comorbidities. There was no statistically significant difference in new diagnoses of any of the side effects at any time point between the 2 groups over 5 years. CONCLUSION: This study represents, to our knowledge, the first longitudinal analysis of systemic neurotoxicity after THA in a large cohort of patients. The results of our study suggest that on the large scale, neurologic side effects previously described do not occur as a common attributable complication. Rather, these cases may be due to individual patient hypersensitivity to metal ions.


Assuntos
Artroplastia de Quadril/instrumentação , Prótese de Quadril/efeitos adversos , Próteses Articulares Metal-Metal/efeitos adversos , Síndromes Neurotóxicas/etiologia , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Feminino , Humanos , Incidência , Masculino , Medicare , Metais/efeitos adversos , Pessoa de Meia-Idade , Síndromes Neurotóxicas/epidemiologia , Polietileno , Desenho de Prótese , Estados Unidos/epidemiologia
12.
Clin Orthop Relat Res ; 474(10): 2134-42, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26987866

RESUMO

BACKGROUND: Isolated revision of the acetabular component in the setting of total hip arthroplasty has an increased risk of dislocation. With local soft tissue destruction frequently associated with failed metal-on-metal (MoM) bearings, it is presumed that acetabular revision of these hips will have even greater risk of complications. However, no study directly compares the complications of MoM with metal-on-polyethylene (MoP) acetabular revisions. QUESTIONS/PURPOSES: In the context of a large database analysis, we asked the following questions: (1) Are there differences in early medical or wound complications after isolated acetabular revision of MoM and MoP bearing surfaces? (2) Are there differences in the frequency of dislocation, deep infection, and rerevision based on the bearing surface of the original implant? METHODS: A review of the 100% Medicare database from 2005 to 2012 was performed using International Classification of Diseases, 9th Revision and Current Procedural Terminology codes. We identified 451 patients with a MoM bearing and 628 patients with a MoP bearing who had an isolated acetabular revision and a minimum followup of 2 years. The incidence, odds ratios, and 95% confidence intervals for early medical or wound complications were calculated using a univariate analysis at 30 days with patient sex and age group-adjusted analysis for blood transfusion. The incidence, odds ratio, and 95% confidence intervals for dislocation, deep infection, and rerevision were calculated using a univariate analysis at 30 day, 90 days, 1 year, and 2 years using a subgroup analysis with the Cochran-Mantel-Haenszel test to adjust for patient gender and age groups. RESULTS: There were no differences between the MoM and MoP isolated acetabular revisions in the incidence of 30-day local complications. There was a greater risk of transfusion in the MoP group than the MoM group (134 of 451 [30%] versus 230 of 628 [37%]; odds ratio [OR], 0.731; 95% confidence interval [CI], 0.565-0.948; p = 0.018). There were no differences at 2 years between the MoM and MoP acetabular revisions in the incidence of dislocation, infection, or rerevision. When analyzed by patient sex and age group, there were more infections in the age 70 to 79 years MoP group compared with MoM (10 of 451 [5%] versus 29 of 628 [10%]; OR, 4.47; CI, 1.699-11.761; p = 0.001). CONCLUSIONS: There were high rates of dislocation, infection, and rerevision in both revision cohorts. The rate of dislocation was not greater after acetabular revision of MoM bearings at 2 years. Based on these findings, clinicians should counsel these patients preoperatively about the risks of these complications. Dual-mobility and constrained components have specific advantages and disadvantages in these settings and should be further studied. LEVEL OF EVIDENCE: Level III, therapeutic study.


Assuntos
Acetábulo/cirurgia , Artroplastia de Quadril/instrumentação , Articulação do Quadril/cirurgia , Prótese de Quadril , Próteses Articulares Metal-Metal , Polietileno , Acetábulo/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/efeitos adversos , Fenômenos Biomecânicos , Distribuição de Qui-Quadrado , Bases de Dados Factuais , Feminino , Articulação do Quadril/fisiopatologia , Humanos , Incidência , Masculino , Medicare , Razão de Chances , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/cirurgia , Desenho de Prótese , Reoperação , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia
13.
J Arthroplasty ; 30(8): 1317-23, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25861918

RESUMO

Over one-million patients worldwide have received metal-on-metal (MoM) hip arthroplasties with a significant proportion requiring revision surgery in the short-term for adverse reaction to metal debris (ARMD). Worldwide authorities have subsequently issued follow-up guidance for MoM hip patients. This article compares follow-up guidelines for MoM hips published by five worldwide authorities, analyses these protocols in relation to published evidence, and assesses the financial implications of these guidelines. A number of major differences exist between authorities regarding patient follow-up, with vast cost differences between protocols (£84 to £988/patient/year for stemmed MoM hips and £0 to £988/patient/year for hip resurfacing). Current worldwide guidance is neither evidence-based nor financially sustainable with most protocols lacking the sensitivity to detect asymptomatic ARMD lesions.


Assuntos
Artroplastia de Quadril/efeitos adversos , Continuidade da Assistência ao Paciente/normas , Próteses Articulares Metal-Metal/efeitos adversos , Guias de Prática Clínica como Assunto/normas , Continuidade da Assistência ao Paciente/economia , Análise Custo-Benefício , Remoção de Dispositivo , Prótese de Quadril , Humanos , Internacionalidade , Falha de Prótese , Reoperação
14.
J Magn Reson Imaging ; 41(5): 1291-9, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-24912802

RESUMO

PURPOSE: To assess lesion detection and artifact size reduction of a multiacquisition variable-resonance image combination, slice encoding for metal artifact correction (MAVRIC-SEMAC) hybrid sequence (MAVRIC-SL) compared to standard sequences at 1.5T and 3T in porcine knee specimens with metal hardware. MATERIALS AND METHODS: Artificial cartilage and bone lesions of defined size were created in the proximity of titanium and steel screws with 2.5 mm diameter in 12 porcine knee specimens and were imaged at 1.5T and 3T magnetic resonance imaging (MRI) with MAVRIC-SL PD and short T1 inversion recovery (STIR), standard fast spin echo (FSE) T2 PD, and STIR and fat-saturated T2 FSE sequences. Three radiologists blinded to the lesion locations assessed lesion detection rates on randomized images for each sequence using receiver operating characteristic (ROC). Artifact length and width were measured. RESULTS: Metal artifact sizes were largest in the presence of steel screws at 3T (FSE T2 FS: 28.7 cm(2) ) and 1.5T (16.03 cm(2) ). MAVRIC-SL PD and STIR reduced artifact sizes at both 3T (1.43 cm(2) ; 2.46 cm(2) ) and 1.5T (1.16 cm(2) ; 1.59 cm(2) ) compared to FS T2 FSE sequences (27.57 cm(2) ; 13.20 cm(2) ). At 3T, ROC-derived AUC values using MAVRIC-SL sequences were significantly higher compared to standard sequences (MAVRIC-PD: 0.87, versus FSE-T2 -FS: 0.73 [P = 0.025]; MAVRIC-STIR: 0.9 vs. T2 -STIR: 0.78 [P = 0.001] and vs. FSE-T2 -FS: 0.73 [P = 0.026]). Similar values were observed at 1.5T. Comparison of 3T and 1.5T showed no significant differences (MAVRIC-SL PD: P = 0.382; MAVRIC-SL STIR: P = 0.071). CONCLUSION: MAVRIC-SL sequences provided superior lesion detection and reduced metal artifact size at both 1.5T and 3T compared to conventionally used FSE sequences. No significant disadvantage was found comparing MAVRIC-SL at 3T and 1.5T, although metal artifacts at 3T were larger. J. Magn. Reson. Imaging 2015;41:1291-1299. © 2014 Wiley Periodicals, Inc.


Assuntos
Artefatos , Parafusos Ósseos , Articulação do Joelho/anatomia & histologia , Prótese do Joelho , Imageamento por Ressonância Magnética/métodos , Próteses Articulares Metal-Metal , Animais , Interpretação de Imagem Assistida por Computador/métodos , Articulação do Joelho/cirurgia , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Marcadores de Spin , Aço Inoxidável , Suínos , Titânio
15.
Bone Joint J ; 96-B(7): 868-75, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24986938

RESUMO

Large-head metal-on-metal (MoM) total hip replacements (THR) have given rise to concern. Comparative studies of small-head MoM THRs over a longer follow-up period are lacking. Our objective was to compare the incidence of complications such as infection, dislocation, revision, adverse local tissue reactions, mortality and radiological and clinical outcomes in small-head (28 mm) MoM and ceramic-on-polyethylene (CoP) THRs up to 12 years post-operatively. A prospective cohort study included 3341 THRs in 2714 patients. The mean age was 69.1 years (range 24 to 98) and 1848 (55.3%) were performed in women, with a mean follow-up of 115 months (18 to 201). There were 883 MoM and 2458 CoP bearings. Crude incidence rates (cases/1000 person-years) were: infection 1.3 vs 0.8; dislocation 3.3 vs 3.1 and all-cause revision 4.3 vs 2.2, respectively. There was a significantly higher revision rate after ten years (adjusted hazard ratio 9.4; 95% CI 2.6 to 33.6) in the MoM group, and ten of 26 patients presented with an adverse local tissue reaction at revision. No differences in mortality, osteolysis or clinical outcome were seen. In conclusion, we found similar results for small-head MoM and CoP bearings up to ten years post-operatively, but after ten years MoM THRs had a higher risk of all-cause revision. Furthermore, the presence of an adverse response to metal debris seen in the small-head MOM group at revision is a cause for concern.


Assuntos
Prótese de Quadril , Próteses Articulares Metal-Metal/efeitos adversos , Adulto , Idoso , Idoso de 80 Anos ou mais , Cimentação , Cerâmica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Polietileno , Estudos Prospectivos , Desenho de Prótese/métodos , Infecções Relacionadas à Prótese/epidemiologia , Reoperação , Estresse Mecânico , Resultado do Tratamento , Adulto Jovem
16.
Int J Technol Assess Health Care ; 30(2): 218-25, 2014 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-24774225

RESUMO

BACKGROUND: Polyethylene (PE) wear is a major contributor to implant loosening following total knee arthroplasty (TKA). Advanced bearings are therefore required in TKA to reduce or eliminate wear-related loosening. A recently introduced bearing that combines oxidized zirconium with highly cross-linked PE has been shown to drastically reduce wear in in vitro settings, due to its improved tribological characteristics in both tibial and femoral components. However, there are no data on its cost-effectiveness. DATA AND METHODS: A Markov model was developed to assess the cost-effectiveness of this low-wear bearing from a German societal perspective. The model population was derived from a registry of 75,000 patients requiring TKA. The model allocated patients to receive either a low-wear or standard articulation, and followed them until death. Revisions and re-revision were included. Input values were derived from registry databases or from published reports in the literature. Threshold analysis and probabilistic sensitivity analysis were conducted to estimate model robustness. RESULTS: The low-wear articulation prevented 24 (2.4 percent) revisions and 8 (0.8 percent) re-revisions. The total incremental cost-effectiveness ratio (ICER) of the low-wear articulation was EUR 16,474 per quality-adjusted life-year (QALY). For patients aged less than 55 years, an ICER of EUR 653 per QALY was observed. For patients aged over 75 years, this value was EUR 83,300. Threshold and probabilistic sensitivity analysis indicated that these findings were reasonably robust. CONCLUSION: Low-wear articulations may be considered cost-effective, although the cost effectiveness is age-dependent, with the cost per QALY being significantly lower for younger people than for older people.


Assuntos
Artroplastia do Joelho/instrumentação , Análise Custo-Benefício , Falha de Equipamento/economia , Próteses Articulares Metal-Metal/economia , Idoso , Artroplastia do Joelho/economia , Humanos , Cadeias de Markov , Pessoa de Meia-Idade
17.
Perspect Biol Med ; 56(4): 584-601, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24769749

RESUMO

The United States has the most expensive, technologically intensive system of medical care in the world, but not the most effective. Reforming health care will require understanding the interactions among the many individuals and institutions that collectively constitute the health-care ecoculture, an ecosystem with a major human component. Because technology is a key driver of health-care costs and a critical component of the patient's experience of American medicine, it is fruitful to consider an example of a particular technology: why it was embraced, who benefited from its use, and the response of the ecoculture when a critical flaw in the technology emerged. The case of the introduction, diffusion, and withdrawal of metal-on-metal hip prostheses will be discussed from the perspective of patients, physicians, device manufacturers, regulators, and the legal system. Each of these groups responded to external stimuli by adaptation in an attempt to maximize its own interests. Interactions between the groups served as a further mechanism of maintaining the status quo within medicine. A single change, such as modification of the payment system or incentivizing patients, is thus unlikely to be effective in transforming health care; instead, a multi-pronged approach, along with reforms outside medicine, will likely be necessary.


Assuntos
Artroplastia de Quadril/instrumentação , Setor de Assistência à Saúde , Prótese de Quadril , Próteses Articulares Metal-Metal , Retirada de Dispositivo Médico Baseada em Segurança , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/economia , Artroplastia de Quadril/ética , Conflito de Interesses , Aprovação de Equipamentos , Difusão de Inovações , Reforma dos Serviços de Saúde , Setor de Assistência à Saúde/economia , Setor de Assistência à Saúde/ética , Prótese de Quadril/efeitos adversos , Prótese de Quadril/economia , Prótese de Quadril/ética , Humanos , Próteses Articulares Metal-Metal/efeitos adversos , Próteses Articulares Metal-Metal/economia , Próteses Articulares Metal-Metal/ética , Segurança do Paciente , Desenho de Prótese , Medição de Risco , Fatores de Risco , Resultado do Tratamento , Estados Unidos
18.
J Arthroplasty ; 27(8 Suppl): 41-5.e1, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22682042

RESUMO

The objective of our study was to determine if authors with conflicts of interest are less likely to report negative study outcomes in metal-on-metal total hip arthroplasty. We performed a systematic review of 3 major orthopedic journals for articles related to metal-on-metal total hip arthroplasty over 12 years. A total of 64 studies reported clinical outcomes and were included. Reviewers assigned a positive, neutral, or negative label. Each study was noted for the presence of absence of a financial conflict. There was a significant trend from positive to negative study outcomes over time (P = .015). A similar negative trend was seen in studies written by authors with financial disclosures (P = .021). Authors with financial conflicts have contributed to the increase in negative outcomes reported in the literature.


Assuntos
Artroplastia de Quadril , Autoria/normas , Conflito de Interesses , Revelação , Prótese de Quadril , Próteses Articulares Metal-Metal , Editoração/normas , Humanos , Falha de Tratamento , Estados Unidos
19.
J Arthroplasty ; 27(8 Suppl): 37-40, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22608689

RESUMO

The purpose of this study was to compare the risk of complication and revision total hip arthroplasty (THA) in Medicare THA patients with different bearings. Using the 100% Medicare database (2005-2009), the adjusted risk of complication and revision THA was calculated for 148,827 THA patients (93,929 metal-on-polyethylene, 49,646 metal-on-metal, 5252 ceramic-on ceramic). Adjusted risk of deep vein thrombosis, dislocation, periprosthetic joint infection (PJI), mechanical loosening, periprosthetic fracture, and revision THA at up to 4 years postoperatively was compared using Cox regression. After adjusting for patient and hospital factors, metal-on-metal bearings were associated with higher risk of PJI (P = .001), mechanical loosening (P < .001), and deep vein thrombosis (P = .031) than metal-on-polyethylene bearings and higher risk of PJI (P = .014) than ceramic-on-ceramic bearings. Overall short-term revision rates did not vary significantly across bearing types, consistent with registry data. The benefits of hard-on-hard bearings in Medicare patients remain unproven, and further study is needed to compare long-term complication and revision rates in Medicare THA patients with different bearing types.


Assuntos
Prótese de Quadril , Próteses Articulares Metal-Metal , Polietileno , Idoso , Idoso de 80 Anos ou mais , Feminino , Prótese de Quadril/efeitos adversos , Humanos , Masculino , Medicare , Próteses Articulares Metal-Metal/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Desenho de Prótese/efeitos adversos , Reoperação/estatística & dados numéricos , Medição de Risco , Estados Unidos
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