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1.
Sci Rep ; 11(1): 5225, 2021 03 04.
Artigo em Inglês | MEDLINE | ID: mdl-33664448

RESUMO

Unicompartimental and total knee arthroplasty is one of the most successful and most performed operations worldwide. In the last years the number of primary knee arthroplasty increased constantly. The aim of this study is to analyze the rising numbers of primary knee arthroplasty and to see how it is used in Germany. In this retrospective study data, provided by the Federal Statistical Office of Germany from 2008 to 2018 was analyzed, using operation codes from the German procedure classification system and characteristics like age, sex and type of the prosthesis. We found a slight increase of unicompartimental and total knee arthroplasty over the investigated 10 years from 150.504 in 2008 up to 168.479 procedures in 2018, with a maximum of 169.334 in 2017. Most patients were female and over 65 years old. Interestingly, there was an obvious decrease of regular TKA in the year 2013, with a relevant impact on the total number of procedures. In the following years the number rised again reaching the former level in 2015 and is still increasing. The highest increase was found in partial knee arthroplasty, with a constant rise every year, starting with 7988 in 2008 up to 21.072 in 2018. In contrast, we found a relevant reduction of constrained prosthesis in primary TKA, whereas the number of semi-constrained prosthesis in primary TKA is again rising after a decrease in 2015. We found that the number of bicondylar TKA and especially UKA increased from 2008 to 2018. Regarding an aging population, we can expect a rising number for Primary knee arthroplasty and in consequence a rising number of revision arthroplasty in the future. This will be a challenging cost factor for the healthcare system in Germany.


Assuntos
Envelhecimento/patologia , Artroplastia do Joelho/estatística & dados numéricos , Prótese do Joelho , Osteoartrite do Joelho/cirurgia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/epidemiologia , Osteoartrite do Joelho/patologia , Desenho de Prótese/normas , Falha de Prótese , Reoperação
2.
Circulation ; 143(2): 178-196, 2021 01 12.
Artigo em Inglês | MEDLINE | ID: mdl-33428433

RESUMO

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.


Assuntos
Valva Aórtica/cirurgia , Calcinose/cirurgia , Implante de Prótese de Valva Cardíaca/normas , Próteses Valvulares Cardíacas/normas , Valva Mitral/cirurgia , Desenho de Prótese/normas , Valva Aórtica/diagnóstico por imagem , Calcinose/diagnóstico por imagem , Cateterismo Cardíaco/métodos , Cateterismo Cardíaco/normas , Cateterismo Cardíaco/tendências , Próteses Valvulares Cardíacas/tendências , Implante de Prótese de Valva Cardíaca/métodos , Implante de Prótese de Valva Cardíaca/tendências , Humanos , Valva Mitral/diagnóstico por imagem , Anuloplastia da Valva Mitral/métodos , Anuloplastia da Valva Mitral/normas , Anuloplastia da Valva Mitral/tendências , Desenho de Prótese/métodos , Desenho de Prótese/tendências
3.
Ann Thorac Surg ; 111(1): 314-326, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33036738

RESUMO

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.


Assuntos
Implante de Prótese de Valva Cardíaca/normas , Próteses Valvulares Cardíacas/normas , Desenho de Prótese/normas , Árvores de Decisões , Humanos
4.
BMC Musculoskelet Disord ; 21(1): 114, 2020 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-32085766

RESUMO

BACKGROUND: Several modern designs of metal-backed glenoids (MBG) have been devised to overcome flaws such as loosening and a high failure rate. This review aimed to compare rates of complications and revision surgeries between cemented polyethylene glenoid (PEG) and three examples of modern MBG designs. METHODS: Literature search was carried out using PubMed, Cochrane Library, EMBASE, and Google Scholar using MeSH terms and natural keywords. A total of 1186 articles were screened. We descriptively analyzed numerical data between the groups and statistically analyzed the categorical data, such as the presence of radiolucent line, loosening, and revision surgery (failure). Articles were divided into three groups based on follow-up duration: < 36-month, 36-72-month, and > 72-month subgroups. RESULTS: This study included 35 articles (3769 shoulders); 25 on cemented PEG and ten on the modern MBG. Mean age was 66.4 (21-93) and 66.5 years (31-88). The mean duration of follow-up was 73.1 (12-211) and 56.1 months (24-100). Overall, the rate of the radiolucent line was 354/1302 (27%) and 47/282 (17%), the loosening rate was 465/3185 (15%) and 22/449 (5%), and the failure rate was 189/3316 (6%) and 11/457 (2%), for PEG and MBG, respectively. The results of < 36-month and 36-72-month subgroups showed lower rates of radiolucency and loosening in the cemented PEG group, but there was no significant difference in failure rate (P = 0.754 and 0.829, respectively). In the > 72-month subgroup, MBG was better in terms of loosening (P < 0.001) and failure rates (P = 0.006). CONCLUSIONS: The modern MBG component, especially TM glenoid, seems to be a promising alternative to cemented PEGs, based on subgroup revision rates according to the follow-up duration and overall results of ROM and clinical scores. All polyethylene glenoids tend to increase loosening and failure over time. Three modern MBG designs seem to have no difference in failure, at least in the < 36-month and 36-72-month subgroups compared to the cemented PEG. More long-term follow-up studies on modern MBG should be ultimately conducted. LEVEL OF EVIDENCE: Level IV, systematic review.


Assuntos
Artroplastia do Ombro/tendências , Cimentos Ósseos , Prótese Articular/tendências , Desenho de Prótese/tendências , Reoperação/tendências , Articulação do Ombro/cirurgia , Artroplastia do Ombro/efeitos adversos , Artroplastia do Ombro/normas , Cimentos Ósseos/normas , Humanos , Prótese Articular/normas , Metais/normas , Polietileno/normas , Desenho de Prótese/normas
5.
Bone Joint J ; 102-B(1): 90-101, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31888362

RESUMO

AIMS: The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA). METHODS: Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening. Cox proportional hazard regression was the primary analytical approach. Manufacturing variables included resin type, crosslinking radiation dose, terminal sterilization method, terminal sterilization radiation dose, stabilization treatment, total radiation dose, packaging, and face asymmetry. Total radiation dose was further divided into G1 (no radiation), G2 (> 0 Mrad to < 5 Mrad), G3 (≥ 5 Mrad to < 10 Mrad), and G4 (≥ 10 Mrad). RESULTS: A total of 5,329 THAs were revised, 1,290 of which were due to aseptic loosening. Total radiation dose, face asymmetry, and stabilization treatments were found to significantly affect implant survival. G1 had the highest revision risk for any reason and for aseptic loosening and G3 and G4 the lowest. Compared with G1, the adjusted hazard ratio for G2 was 0.74 (95% confidence interval (CI) 0.64 to 0.86), G3 was 0.36 (95% CI 0.30 to 0.43), and G4 was 0.38 (95% CI 0.31 to 0.47). The cumulative incidence of revision for aseptic loosening at 12 years was 0.52 and 0.54 per 100 THAs for G3 and G4, respectively, compared with 1.95 per 100 THAs in G1. Asymmetrical liners had a lower revision risk due to aseptic loosening and reasons other than aseptic loosening compared with symmetric (flat) liners. In G3 and G4, stabilization with vitamin E and heating above melting point performed best. CONCLUSION: Polyethylene liners with a total radiation dose of ≥ 5 Mrad, an asymmetrical liner face, and stabilization with heating above the melting point demonstrate best survival. Cite this article: Bone Joint J 2020;102-B(1):90-101.


Assuntos
Artroplastia de Quadril/normas , Prótese de Quadril/normas , Polietileno , Adulto , Idoso , Artroplastia de Quadril/instrumentação , Artroplastia de Quadril/estatística & dados numéricos , Tecnologia Biomédica , Feminino , Prótese de Quadril/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese/normas , Desenho de Prótese/estatística & dados numéricos , Falha de Prótese , Reoperação/estatística & dados numéricos , Fatores de Risco
6.
J Thorac Cardiovasc Surg ; 159(3): 865-896, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31983522
7.
Braz J Cardiovasc Surg ; 34(5): 618-623, 2019 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-31719014

RESUMO

In aortic valve disease cases, prosthetic valves have been used for valve replacement, however, these prostheses have inherent problems, and their quality in some countries is lower comparing to new-generation models, causing shorter durability. Aortic valve neocuspidization (AVNeo) has emerged as an option, which can be applied to a wide spectrum of these diseases. Despite the promising results, this procedure is not widely spread among cardiac surgeons yet. We developed a surgical technique combining Bentall and Ozaki procedures to treat patients with concomitant ascending aorta replacement and AVNeo and we describe it in this paper.


Assuntos
Aorta/cirurgia , Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas/normas , Desenho de Prótese/normas , Humanos , Ilustração Médica , Reprodutibilidade dos Testes
8.
Rev. bras. cir. cardiovasc ; 34(5): 618-623, Sept.-Oct. 2019. tab, graf
Artigo em Inglês | LILACS | ID: biblio-1042033

RESUMO

Abstract In aortic valve disease cases, prosthetic valves have been used for valve replacement, however, these prostheses have inherent problems, and their quality in some countries is lower comparing to new-generation models, causing shorter durability. Aortic valve neocuspidization (AVNeo) has emerged as an option, which can be applied to a wide spectrum of these diseases. Despite the promising results, this procedure is not widely spread among cardiac surgeons yet. We developed a surgical technique combining Bentall and Ozaki procedures to treat patients with concomitant ascending aorta replacement and AVNeo and we describe it in this paper.


Assuntos
Humanos , Aorta/cirurgia , Valva Aórtica/cirurgia , Desenho de Prótese/normas , Próteses Valvulares Cardíacas/normas , Implante de Prótese de Valva Cardíaca/métodos , Doenças das Valvas Cardíacas/cirurgia , Reprodutibilidade dos Testes , Ilustração Médica
9.
Eur J Vasc Endovasc Surg ; 58(5): 746-755, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31548160

RESUMO

OBJECTIVES: The dynamic endovascular environment of stent grafts may influence long term outcome after endovascular aneurysm repair (EVAR). The sealing and fixation of a stent graft to the aortic wall is challenged at every heartbeat, yet knowledge of the cardiac induced dynamics of stent grafts is sparse. Understanding the stent-artery interaction is crucial for device development and may aid the prediction of failure in the individual patient. The aim of this work was to establish quantitative stent graft motion in multiphasic electrocardiogram (ECG) gated computed tomography (CT) by image registration and segmentation techniques. METHODS: Experimental validation was performed by evaluating a series of ECG gated CT scans of a stent graft moving at different amplitudes of displacement at different virtual heart rates using a motion generating device with synchronised ECG triggering. The methodology was further tested on clinical data of patients treated with EVAR devices with different stent graft designs. Displacement during the cardiac cycle was analysed for points on the fixating stent rings, the branches or fenestrations, and the spine. RESULTS: Errors for the amplitude of displacement measured in vitro at individual points on the wire frame were at most 0.3 mm. In situ cardiac induced displacement of the devices was found to differ per location and also depended on the type of stent graft. Displacement during the cardiac cycle was greatest in a fenestrated device and smallest in a chimney graft sac anchoring endosystem, with maximum displacement varying from 0.0 to 1.4 mm. There was no substantial displacement measurable in the spine. CONCLUSIONS: A novel methodology to quantify and visualise stent graft motion in multiphasic ECG gated CT has been validated in vitro and tested in vivo. This methodology enables further exploration of in situ motion of different stent grafts and branch stents and their interaction with native vessels.


Assuntos
Angiografia por Tomografia Computadorizada/métodos , Eletrocardiografia/métodos , Procedimentos Endovasculares/instrumentação , Hemodinâmica , Retenção da Prótese/métodos , Interpretação de Imagem Radiográfica Assistida por Computador/métodos , Stents/efeitos adversos , Aneurisma da Aorta Abdominal/cirurgia , Análise de Falha de Equipamento/métodos , Humanos , Teste de Materiais , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/fisiopatologia , Complicações Pós-Operatórias/prevenção & controle , Desenho de Prótese/classificação , Desenho de Prótese/normas
10.
J Orthop Surg Res ; 14(1): 279, 2019 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-31462276

RESUMO

INTRODUCTION: In this study, we described a positioner which allows a combination of preoperative plan and intraoperative insertion of the cup to improve the reconstruction of the rotation center of the hip. MATERIALS AND METHODS: A retrospective study was conducted on 32 consecutive patients (group A) using this positioner and 40 consecutive patients (group B) using conventional method; radiological parameters and clinical measurements before operation and at last follow-up were collected and evaluated. RESULTS: Group A had a reconstructed center of rotation (COR) that was 0.19 mm closer to the anatomic COR in height (P < 0.005), compared with group B with 3.45 mm vertical dislocation. There were no statistically significant differences in the horizontal displacement between the two groups. The accuracy of cup inclination was 42.14 ± 3.57 in the group A and 38.73 ± 7.65 in the group B (P = 0.015). The accuracy of cup anteversion was 14.82 ± 1.44 in the group A and 13.08 ± 5.95 in the group B (P = 0.082). All cups in the group A were radiologically stable, while one cup in the group B was radiologically unstable and was successfully treated with second-stage revision. Both of the groups obtained a higher mean postoperative Harris Hip Score. CONCLUSIONS: Utilizing this positioner helps to restore the COR position more precisely and provides satisfactory radiological and clinical outcomes in the short term, and more studies are required before its widespread adoption for complicated cases.


Assuntos
Acetábulo/diagnóstico por imagem , Acetábulo/cirurgia , Artroplastia de Quadril/instrumentação , Artroplastia de Quadril/normas , Prótese de Quadril/normas , Desenho de Prótese/normas , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
11.
J Orthop Surg Res ; 14(1): 225, 2019 Jul 19.
Artigo em Inglês | MEDLINE | ID: mdl-31324195

RESUMO

BACKGROUND: Several hydroxyapatite (HA)-coated femoral stems from a single manufacturer were identified to have aseptically loosened at mid-term follow-up despite prior radiographic appearance of osseointegration. Possible causes and associated risk factors for stem loosening were explored through radiographic review and implant retrieval analysis. METHODS: Forty-six retrieved hip stems (Corail, DePuy-Synthes) were identified and grouped by bearing type: metal-on-metal (MoM), metal-on-polyethylene, and ceramic-on-ceramic. Stem lucency was graded on post-operative radiographs up to the time of revision. Stems were examined for stripping of the HA coating, taper corrosion, and bearing wear in metal-on-metal cases. Patient demographics, implant design features, and perioperative data were collected from electronic databases and patient charts. RESULTS: Aseptic loosening occurred in 37% of cases examined. MoM bearings were associated with 7.25 times greater risk of loosening compared to other bearing types. Stem radiolucency was more prevalent for MoM cases and, although not statistically significant, demonstrated progressive lucency. Taper corrosion appeared more severe for MoM cases and correlated with proximal stem radiolucency. Removal of the HA coating from the stems was associated with both taper corrosion and MoM bearing wear. Length of implantation was a confounding factor for the MoM cases. CONCLUSION: This study has demonstrated a high risk of mid-term loosening of previously osseointegrated HA-coated femoral stems when paired with a MoM bearing. The mechanism of loosening appears progressive in nature and related to the MoM bearing, possibly interacting with the HA coating. If such loosening is recognized early, rapid revision may allow for retention of the femoral stem.


Assuntos
Durapatita/normas , Análise de Falha de Equipamento/normas , Fêmur/cirurgia , Prótese de Quadril/normas , Próteses Articulares Metal-Metal/normas , Falha de Prótese , Adulto , Idoso , Idoso de 80 Anos ou mais , Durapatita/efeitos adversos , Análise de Falha de Equipamento/métodos , Feminino , Seguimentos , Prótese de Quadril/efeitos adversos , Humanos , Masculino , Próteses Articulares Metal-Metal/efeitos adversos , Pessoa de Meia-Idade , Desenho de Prótese/efeitos adversos , Desenho de Prótese/normas , Falha de Prótese/efeitos adversos , Estudos Retrospectivos
12.
J Neurointerv Surg ; 11(10): 1024-1025, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31197026

RESUMO

Endosaccular flow disruption is an innovative method of treating wide-necked complex aneurysms. Currently four types of devices have obtained the CE mark for use within Europe. These are the Woven EndoBridge device (WEB), the Luna Aneurysm Embolization System, the Medina Embolic Device (Medtronic), and the Contour Neurovascular System. The aim of this article is to provide an overview of these devices and to summarize the evidence in the literature pertaining to the treatment of intracranial aneurysms with them.


Assuntos
Aneurisma/diagnóstico por imagem , Aneurisma/cirurgia , Procedimentos Endovasculares/instrumentação , Procedimentos Endovasculares/normas , Desenho de Prótese/normas , Sistemas de Liberação de Medicamentos/métodos , Sistemas de Liberação de Medicamentos/normas , Embolização Terapêutica/instrumentação , Embolização Terapêutica/normas , Europa (Continente) , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/cirurgia , Resultado do Tratamento
13.
J Orthop Surg Res ; 14(1): 139, 2019 May 16.
Artigo em Inglês | MEDLINE | ID: mdl-31097037

RESUMO

BACKGROUND: Single-radius (SR) prostheses and multi-radius (MR) prostheses have different theoretical advantages; however, there has been a paucity of evaluations comparing the two. This study was designed to compare the 10-year clinical, radiological, and survival outcomes of SR and MR posterior-stabilized prostheses in total knee arthroplasty (TKA). METHODS: In this retrospective cohort study, 220 consecutive patients undergoing TKA between October 2006 and October 2007 were divided into the SR group (106 patients, Stryker Scorpio NRG) and the MR group (114 patients, DePuy Sigma PFC), with a minimum follow-up of 10 years. Clinical, functional, and radiological outcomes, as well as satisfaction rates and survival results, were evaluated. RESULTS: Hospital for Special Surgery and Short Form-12 health survey scores were all significantly improved in both groups at the final follow-up (P < 0.05), but the groups did not differ. The SR group had significantly less anterior knee pain (AKP) and painless crepitation (P < 0.05). Radiological results in terms of radiolucent lines and component position angle showed no differences between groups. The Kaplan-Meier survival curve estimates at 10 years were not significantly different between the groups (P = 0.4172). CONCLUSION: Both SR and MR posterior-stabilized prostheses can lead to satisfactory outcomes. The SR prosthesis design gave less anterior knee pain than did the MR prostheses. Two prostheses showed no differences in terms of clinical scales, radiological results, satisfaction rates, and survival results at a long-term follow-up. More accurate measurements are required.


Assuntos
Artroplastia do Joelho/tendências , Prótese do Joelho/tendências , Desenho de Prótese/tendências , Rádio (Anatomia)/cirurgia , Idoso , Artroplastia do Joelho/instrumentação , Estudos de Coortes , Feminino , Seguimentos , Humanos , Instabilidade Articular/diagnóstico por imagem , Instabilidade Articular/cirurgia , Prótese do Joelho/normas , Masculino , Pessoa de Meia-Idade , Desenho de Prótese/normas , Rádio (Anatomia)/diagnóstico por imagem , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
14.
BMJ Open ; 9(4): e026685, 2019 04 29.
Artigo em Inglês | MEDLINE | ID: mdl-31036708

RESUMO

OBJECTIVES: To investigate the relative performance of hip prosthesis constructs as compared with the best performing prosthesis constructs and illustrate the substantial variability in performance of currently used prostheses. DESIGN: A non-inferiority study. SETTING: The National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR). PARTICIPANTS: All patients with a primary total hip replacement registered in the NJR between 1 April 2003 and 31 December 2016. MAIN OUTCOME MEASURES: Kaplan-Meier failure function for hip prosthesis constructs. Failure difference between best performing construct and remaining constructs. METHODS: Using a non-inferiority analysis, the performance of hip prosthesis constructs by brand were compared with the best performing contemporary construct. Construct failure was estimated using the 1-Kaplan-Meier survival function method, that is, an estimate of net failure. The difference in failure between the contemporary benchmark and all other constructs was tested. RESULTS: Of the 4442 constructs used, only 134 had ≥500 procedures at risk at 3 years postprimary, 89 of which were not demonstrated to be inferior to the benchmark by at least 100% relative risk. By 10 years postprimary, there were 26 constructs with ≥500 at risk, 13 of which were not demonstrated to be inferior by at least 20% relative risk.Even fewer constructs were not inferior to the benchmark when analysed by age and gender. At 5 years postprimary, there were 15 constructs in males and 11 in females, aged 55-75 years, not shown to be inferior. CONCLUSIONS: There is great variability in construct performance and the majority of constructs have not been demonstrated to be non-inferior to contemporary benchmarks. These results can help to inform patients, clinicians and commissioners when considering hip replacement surgery.


Assuntos
Artroplastia de Quadril/estatística & dados numéricos , Prótese de Quadril/normas , Desenho de Prótese/normas , Falha de Prótese , Idoso , Artroplastia de Quadril/normas , Benchmarking/métodos , Inglaterra , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Irlanda do Norte , Desenho de Prótese/instrumentação , Sistema de Registros , Distribuição por Sexo , Fatores de Tempo , País de Gales
15.
BMJ Open ; 9(4): e026736, 2019 04 29.
Artigo em Inglês | MEDLINE | ID: mdl-31036709

RESUMO

OBJECTIVES: To investigate the relative performance of knee replacement constructs compared with the best performing construct and illustrate the substantial variability in performance. DESIGN: A non-inferiority study. SETTING: England and Wales. PARTICIPANTS: All primary total and unicondylar knee replacements performed and registered in the National Joint Registry between 1 April 2003 and 31 December 2016. MAIN OUTCOME MEASURES: Kaplan-Meier failure function for knee replacement constructs. Failure difference between best performing construct (the benchmark) and other constructs. METHODS: Using a non-inferiority analysis, the performance of knee replacement constructs by brand were compared with the best performing construct. Construct failure was estimated using the 1-Kaplan Meier method, that is, an estimate of net failure. The difference in failure between the contemporary benchmark construct and all other constructs were tested. RESULTS: Of the 449 different knee replacement constructs used, only 27 had ≥500 procedures at risk at 10 years postprimary, 18 of which were classified as inferior to the benchmark by at least 20% relative risk of failure. Two of these 18 were unicondylar constructs that were inferior by at least 100% relative risk. In men, aged 55-75 years, 12 of 27 (44%) constructs were inferior by at least 20% to the benchmark at 7 years postprimary. In women, aged 55-75 years, 8 of 32 (25%) constructs were inferior at 7 years postprimary. Very few constructs were classified as non-inferior to the contemporary benchmark. CONCLUSIONS: There are few knee replacement constructs that can be shown to be non-inferior to a contemporary benchmark. Unicondylar knee constructs have, almost universally, at least 100% worse revision outcomes compared with the best performing total knee replacement. These results will help to inform patients, clinicians and commissioners when considering knee replacement surgery.


Assuntos
Artroplastia do Joelho/estatística & dados numéricos , Prótese do Joelho/normas , Desenho de Prótese/normas , Falha de Prótese , Idoso , Artroplastia do Joelho/normas , Benchmarking/métodos , Inglaterra , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Irlanda do Norte , Sistema de Registros , Distribuição por Sexo , Fatores de Tempo , País de Gales
16.
J Thorac Cardiovasc Surg ; 158(4): 1041-1054, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31084981

RESUMO

Intraoperative surgical prosthetic heart valve (SHV) choice is a key determinant of successful surgery and positive postoperative outcomes. Currently, many controversies exist around the sizing and labeling of SHVs rendering the comparison of different valves difficult. To explore solutions, an expert Valve Labelling Task Force was jointly initiated by the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS). The EACTS-STS-AATS Valve Labelling Task Force, comprising cardiac surgeons, cardiologists, engineers, regulators and representatives from the International Organization for Standardization (ISO), and major valve manufacturers, held its first in-person meeting in February 2018 in Paris, France. This article was derived from the meeting's discussions. The Task Force identified the following areas for improvement and clarification: reporting of physical dimensions and characteristics of SHVs determining and labeling of SHV size, in vivo and in vitro testing, and reporting of SHV hemodynamic performance and thrombogenicity. Furthermore, a thorough understanding of the regulatory background and the role of the applicable ISO standards, together with close cooperation between all stakeholders (including regulatory and standard- setting bodies), is necessary to improve the current situation. Cardiac surgeons should be provided with appropriate information to allow for optimal SHV choice. This first article from the EACTS-STS-AATS Valve Labelling Task Force summarizes the background of SHV sizing and labeling and identifies the most important elements where further standardization is necessary.


Assuntos
Bioprótese/normas , Cardiologia/normas , Qualidade de Produtos para o Consumidor/normas , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/normas , Próteses Valvulares Cardíacas/normas , Rotulagem de Produtos/normas , Desenho de Prótese/normas , Tomada de Decisão Clínica , Consenso , Análise de Falha de Equipamento/normas , Implante de Prótese de Valva Cardíaca/efeitos adversos , Humanos , Seleção de Pacientes , Falha de Prótese , Sociedades Médicas
17.
J Orthop Surg Res ; 14(1): 156, 2019 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-31133027

RESUMO

BACKGROUND: An increased occurrence of cortical hypertrophy (CH) was observed 1-2 years after implanting short curved Fitmore hip stems. There are no published data about either the clinical relevance or the progression of CH over the long term. METHODS: Ninety-six primary total hip arthroplasties were performed between 2008 and 2010 using the Fitmore hip stem. Clinical and radiological parameters were recorded preoperatively and at 1, 2, 3, and 5 year follow-up. RESULTS: CH appeared mainly on antero-posterior radiographs in Gruen Zones 2, 3, 5, and 6. After 1 year, the diameter was 10 ± 2 mm and remained constant thereafter. The CH rate after 1 year was 69% and after 5 years 71%. Subsidence after 1 year was 1.6 ± 1.55 mm and 1.93 ± 1.72 mm after 5 years. Cortical thinning was 46% after 1 year and 56% after 5 years, mainly in Gruen Zones 7 and 8. In the first year radiolucencies were found in 51% in all Gruen Zones, and in 20% after 5 years. Patient, implant, and surgical factors did not correlate with radiological outcomes except that larger stems had more CH. After 5 years, the Harris Hip Score had improved from 59 to 94 and the Oxford Hip Score from 22 to 41. Radiographic parameters, notably CH, were not associated with clinical outcomes except that cortical thinning correlated with lower outcome scores. CONCLUSIONS: CH correlated neither with clinical outcome nor with patient, surgical or implant factors, except for a positive correlation with stem size. The Fitmore hip stems settled within the first year to a stable fixation and then remained almost unchanged. However, cortical thinning is common in Gruen Zone 7 and 8 meaning that there is stress-shielding.


Assuntos
Artroplastia de Quadril/instrumentação , Artroplastia de Quadril/tendências , Osso Cortical/diagnóstico por imagem , Prótese de Quadril/tendências , Hiperostose/diagnóstico por imagem , Desenho de Prótese/tendências , Idoso , Estudos de Coortes , Feminino , Seguimentos , Prótese de Quadril/normas , Humanos , Hiperostose/etiologia , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Desenho de Prótese/normas
18.
Curr Opin Urol ; 29(4): 419-425, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-30950867

RESUMO

PURPOSE OF REVIEW: Interactions between biomaterials and biomaterial-delivering cells and the host tissues are complexly affected by the material itself, the ultrastructure of the overall construct and cells and other bioactive factors involved. The aim of this review is to review the current understanding on the definitions of biocompatibility and current advances in improving biocompatability of tissue-engineered constructs. RECENT FINDINGS: Some synthetic materials are associated with more foreign body reactions compared with natural materials; however, they allow fabrication of materials with a great diversity of physical and mechanical properties. Material design strategies can be tailored to mimic the natural extracellular matrix topography. There are also advancements in the pharmacological functionalization of materials with improved angiogenic potential that can lead to better tissue response. Stem cells are also used to improve the tissue response of tissue-engineered materials; however, the recent regulations on regenerative medicine products necessitate significant regulatory approval processes for these. SUMMARY: The biggest challenge faced in translation of tissue-engineered constructs into clinical practice relates to their engraftment and poor tissue integration into the challenging wound bed of the pelvic floor. Biocompatibility of tissue engineered constructs can theoretically be improved by the incorporation of bioactive agents, such as vitamins C or oestradiol.


Assuntos
Materiais Biocompatíveis/normas , Reação a Corpo Estranho/prevenção & controle , Transplante de Células-Tronco Mesenquimais/normas , Diafragma da Pelve/cirurgia , Próteses e Implantes/efeitos adversos , Engenharia Tecidual/normas , Materiais Biocompatíveis/farmacologia , Terapia Baseada em Transplante de Células e Tecidos/métodos , Terapia Baseada em Transplante de Células e Tecidos/normas , Reação a Corpo Estranho/etiologia , Reação a Corpo Estranho/fisiopatologia , Humanos , Transplante de Células-Tronco Mesenquimais/métodos , Diafragma da Pelve/fisiopatologia , Desenho de Prótese/métodos , Desenho de Prótese/normas , Medicina Regenerativa/legislação & jurisprudência , Medicina Regenerativa/normas , Engenharia Tecidual/métodos , Cicatrização
19.
Orthop Clin North Am ; 50(2): 151-158, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30850074

RESUMO

Hip dislocation remains a major concern following total hip arthroplasty due to its high frequency and economic burden. This article evaluates the cost-effectiveness regarding dual mobility as an alternative to standard implant designs. A review of literature analyzing the PubMed Central database was undertaken using the following terms in the primary query: dual mobility, cost-effectiveness, cost-analysis, or economic analysis. Dual mobility systems may be a cost-effective alternative when the price of the implant does not exceed the traditional system by $1023. Dual mobility cups may be an essential component for the future success of value-based total hip arthroplasty.


Assuntos
Artroplastia de Quadril/economia , Análise Custo-Benefício/economia , Luxação do Quadril/cirurgia , Prótese de Quadril/economia , Amplitude de Movimento Articular/fisiologia , Idoso , Algoritmos , Artroplastia de Quadril/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Desenho de Prótese/normas , Estudos Retrospectivos
20.
J Orthop Surg Res ; 14(1): 57, 2019 Feb 19.
Artigo em Inglês | MEDLINE | ID: mdl-30782186

RESUMO

PURPOSE: Ceramic bearings have been widely used in total hip arthroplasty (THA), which resulted in satisfactory clinical outcomes due to the excellent tribological characteristics of the implants. However, ceramic components are not commonly used in total knee arthroplasty (TKA) because of brittleness. This study aimed to gather and analyze information regarding the clinical outcomes (including survival without revision, causes of revision, functional outcome, and incidence of loosening) and reach a definitive conclusion about the use of ceramic femoral components in total knee arthroplasty. METHODS: MEDLINE, EMBASE, Cochrane, and ClinicalTrials.gov databases were searched for studies that reported the clinical and/or radiological outcomes with or without survival data of ceramic TKA implants and that included more than 10 patients with a minimum of 1 year follow-up. RESULTS: From an initial sample of 147, there were 14 studies that met the inclusion criteria. Overall, there was a notable enhancement of joint function after the procedure, with a satisfactory mid- and long-term survival of the ceramic components, which is comparable to that of the conventional alloy components reported previously. In addition, the revision rate was reported to be between 0% and 14.37% according to the included studies. However, revision due to aseptic loosening, wear, and component fracture appeared to be rare, demonstrating the safety of in vivo use of ceramic bearings in the TKA procedure. CONCLUSIONS: Ceramic TKA implants show similar post-operative clinical results and survival rate compared to their conventional metallic counterparts. Our results confirmed the safety of in vivo use of ceramic bearings in TKA, with rare implant breakage and aseptic loosening. Considering the excellent characteristics of the tribology of ceramics, the clinical use of ceramic prostheses in TKA could be promising.


Assuntos
Artroplastia do Joelho/tendências , Cerâmica/normas , Fêmur/cirurgia , Falha de Prótese/tendências , Artroplastia do Joelho/instrumentação , Ensaios Clínicos como Assunto/métodos , Humanos , Desenho de Prótese/normas , Desenho de Prótese/tendências , Resultado do Tratamento
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