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INTRODUCTION: The present study aimed to investigate differences in survivorship between medial and lateral unicompartmental knee arthroplasty (UKA) by analyzing the data of an Italian regional registry. The hypothesis was that, according to recent literature, lateral implants have comparable survivorship with regard to the medial implants. MATERIALS AND METHODS: The Register of Orthopaedic Prosthetic Implants (RIPO) of Emilia-Romagna (Italy) database was searched for all UKAs between July 1, 2000, and December 31, 2019. For both cohorts, subject demographics and reasons for revision were presented as a percentage of the total cohort. Kaplan-Meier survivorship analysis was performed using revision of any component as the endpoint and survival times of unrevised UKAs taken as the last observation date (December 31, 2019, or date of death). RESULTS: Patients living outside the region and symmetrical implants (which do not allow the compartment operated to be traced) were excluded. 5571 UKAs implanted on 5172 patients (5215 medial UKAs and 356 lateral UKAs) were included in the study. The survivorship analysis revealed 13 failures out of 356 lateral UKAs (3.7%) at a mean follow-up of 6.3 years and 495 failures out of 5215 medial UKAs (9.5%) at a mean follow-up of 6.7 years. The medial UKAs had a significantly higher risk of failure, with a Hazard Ratio of 2.6 (CI 95% 1.6-4.8; p < 0.001), adjusted for age, gender, weight, and mobility of the insert. Both the groups revealed a good survival rate, with 95.2% of lateral implants and 87.5% of medial implants still in situ at 10 years of follow-up. CONCLUSIONS: Lateral UKA is a safe procedure showing longer survivorship than medial UKAs (95.2% and 87.5% at 10 years, respectively) in the present study. LEVEL OF EVIDENCE: Level 3, therapeutic study.
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Artroplastia do Joelho , Prótese do Joelho , Ortopedia , Osteoartrite do Joelho , Humanos , Artroplastia do Joelho/métodos , Reoperação , Desenho de Prótese , Resultado do Tratamento , Osteoartrite do Joelho/cirurgia , Articulação do Joelho/cirurgiaRESUMO
OBJECTIVES: To analyze post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA). BACKGROUND: The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports. RESULTS: Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.
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Artéria Femoral , Marketing , Bases de Dados Factuais , Artéria Femoral/diagnóstico por imagem , Humanos , Resultado do Tratamento , Estados Unidos/epidemiologia , United States Food and Drug AdministrationRESUMO
OBJECTIVES: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). BACKGROUND: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. RESULTS: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.
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Dispositivos de Oclusão Vascular , Artéria Femoral/cirurgia , Humanos , Suturas , Resultado do Tratamento , Estados Unidos , United States Food and Drug AdministrationRESUMO
PURPOSE: The purpose of this study is to analyse long-term unicompartmental knee arthroplasty (UKA) focusing on survivorship, causes of failure and revision strategy. METHODS: This study is a retrospective analysis of data from a regional arthroplasty registry for cases performed between 2000 and 2017. A total of 6453 UKAs were identified and the following information was analysed: demographic data, diagnosis leading to primary implant, survivorship, complication rate, causes of failure, revision strategies. UKA registry data were compared with total knee arthroplasty (TKA) registry data of 54,012 prostheses, which were implanted in the same time period. RESULTS: 6453 UKAs were included in the study: the vast majority of them (84.4%) were implanted due to primary osteoarthritis followed by deformity (7.1%) and necrosis of the condyle (5.1%). When compared to TKA, UKA showed lower perioperative complication rate (0.3% compared to 0.6%) but higher revision rate (18.2% at 15 years, compared to 6.2% for TKA). No correlation was found between diagnosis leading to primary implant and prosthesis survival. The most frequent cause of failure was total aseptic loosening (37.4%), followed by pain without loosening (19.8%). Of the 620 UKAs requiring revision, 485 were revised with a TKA and 61 of them required a re-revision; on the other hand, of the 35 cases where another UKA was implanted, 16 required a re-revision. CONCLUSION: UKA is associated with fewer perioperative complications but higher revision rates when compared to TKA. Its survivorship is not affected by the diagnosis leading to primary implant. Revision surgery of a failed UKA should be performed implanting a TKA, which is associated with a lower re-revision rate when compared to another UKA. LEVEL OF EVIDENCE: Level 3, therapeutic study.
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Artroplastia do Joelho , Prótese do Joelho , Osteoartrite do Joelho , Artroplastia do Joelho/efeitos adversos , Humanos , Osteoartrite do Joelho/cirurgia , Falha de Prótese , Sistema de Registros , Reoperação , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Purpose of this study was to determine implant survivorship and resultant outcomes, including modes of failure, for metal-on-metal hip resurfacing through the Hueter anterior approach (HAA). METHODS: Retrospective review of cases from 2006 to 2015, resulted in 555 metal-on-metal hip resurfacing via HAA, mean age 49.4 ± 6.9 years and mean BMI 28.1 ± 5.3. Kaplan-Meier curves were used to assess implant survivorship. Evaluation of technique was based on radiographic assessment of component position at 6 weeks. Patient-reported outcome measures were assessed using 12-Item Short Form Survey 12, University of California Los Angeles activity, Western Ontario and McMaster Universities Osteoarthritis Index, and hip disability osteoarthritis outcome scores. RESULTS: At a mean follow-up of 9.18 years, survivorship was 95.0% at 5 years (95% CI: 93.2-96.8 years) and 92.5% at 10 years (95% CI: 90.0-95.0 years); men at 96.1% (95% CI: 94.3-97.9) and 93.8% (95% CI: 91.1-96.5), and women at 88.8% (95% CI: 81.9-95.7) and 85.6% (95% CI: 77.6-93.6), 5 and 10 years, respectively (P = .033). There were 37 revisions to total hips (7%) at a mean time of 3.3 years (SD 2.7). Indications for revision were aseptic loosening of acetabular (n = 12) and femoral component (n = 7) and pseudotumor (n = 6). Radiographic parameters were respectable and consistent, median acetabular inclination angle 41.2° and femoral stem shaft angle 137.7°. Patient-reported outcome measure scores significantly improved and remained stable at 2 and 5 years postoperatively. CONCLUSION: Although choice of surgical approach should always be based on surgeon's technical expertise, this study has shown that HAA is safe and effective for hip resurfacing. Mindful attention to long-term metal ion exposure must still be considered.
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Artroplastia de Quadril , Prótese de Quadril , Próteses Articulares Metal-Metal , Adulto , Feminino , Seguimentos , Humanos , Masculino , Próteses Articulares Metal-Metal/efeitos adversos , Pessoa de Meia-Idade , Desenho de Prótese , Falha de Prótese , Reoperação , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Patients between 45 and 54 years old will be the fastest-growing cohort seeking total knee arthroplasty (TKA) over the next 15 years. The purpose of this investigation is to determine the clinical outcomes of TKA in patients less than 50 years old at a minimum of 10 years. We hypothesized that this patient population would have a high rate of survivorship that is similar to that of older patients. METHODS: We reviewed 298 consecutive TKAs on 242 patients at a minimum of 10 years postoperatively. Twenty patients died and 30 TKAs were lost to follow-up leaving 248 TKAs in 202 patients (91 male, 111 female) with a mean age of 45.7 years (range, 26-49) at the time of surgery. Patient-reported outcomes, survivorship, causes of reoperation, and initial postoperative radiographic parameters were collected. RESULTS: At a mean of 13.0 years, there were 9 revisions for tibial loosening (3.6%), 8 for deep infection (3.2%), 7 for polyethylene wear (2.8%), and 3 for failed ingrowth of a cementless femoral component (1.2%). Kaplan-Meier analysis demonstrated 92.0% survivorship with failures defined as aseptic component revision and 83.9% survivorship for all-cause reoperation at 13 years. Patients with tibial alignment of 4° or more of varus or 10° or more of posterior slope were found to have increased rate of failure. CONCLUSION: While overall durability was good in this young patient population, tibial fixation and deep infection were relatively common causes of failure. In addition, increased tibial varus and slope were found to increase the rate of failure. Furthermore, the nearly 3% risk of revision for wear suggests that the use of more wear-resistant bearing surfaces may reduce the risk of failure in this patient population.
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Artroplastia do Joelho/efeitos adversos , Prótese do Joelho/efeitos adversos , Adulto , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Razão de Chances , Medidas de Resultados Relatados pelo Paciente , Polietileno , Período Pós-Operatório , Desenho de Prótese , Falha de Prótese , Reoperação/efeitos adversos , Estudos Retrospectivos , Risco , Tíbia/fisiologia , Tíbia/cirurgiaRESUMO
BACKGROUND: Unicompartmental knee arthroplasty (UKA) is an alternative to total knee arthroplasty in isolated medial osteoarthritis (OA). However, despite satisfactory reports on the clinical performance, UKA revision rates are still concerning. This retrospective study reports on the long-term survivorship, functional outcomes, and reasons for revision in fixed-bearing UKA implant. METHODS: Between 2005 and 2013, 460 consecutive patients were treated with medial UKA in one center using a fixed-bearing UKA system. All patients were evaluated clinically and radiographically before surgery, and postoperatively at 6 weeks and 1 year. Between February and April 2016, all patients were reevaluated using the Oxford Knee Score. RESULTS: Mean follow-up was 5.5 (range, 2-11) years. The mean Oxford Knee Score was 43.3 (7-48), with 94.6% patients showing excellent or good outcomes. Eleven revisions (2.4%) occurred. The survivorship was 97.2% (95% confidence interval, 96.2%-99.2%) and 94.2% (95% confidence interval, 86.8%-97.5%) at 5 and 10 years, respectively, with revision of any implant component for any reason as the end point. The causes for revision were infection (4 cases, 0.9%); lateral pain due to overload (2 cases, 0.4%); progression of OA in the lateral compartment (2 cases, 0.4%); patellar pain with patellar chondropathy (2 cases, 0.4%); and severe synovitis (1 cases, 0.2%). There were no reoperations or revisions for component loosening, instability, component wear, or periprosthetic fracture. CONCLUSION: A fixed-bearing UKA system is a good treatment option for medial end-stage OA. Satisfactory functional results were achieved with low incidence of complications and revisions.
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Artroplastia do Joelho , Articulação do Joelho/cirurgia , Prótese do Joelho , Osteoartrite do Joelho/cirurgia , Idoso , Progressão da Doença , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Osteonecrose/cirurgia , Dor/cirurgia , Patela/cirurgia , Período Pós-Operatório , Desenho de Prótese , Falha de Prótese , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Análise de Sobrevida , Sinovite/etiologia , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Failure rates are higher in medial unicompartmental knee arthroplasty (UKA) than total knee arthroplasty. To improve these failure rates, it is important to understand why medial UKA fail. Because individual studies lack power to show failure modes, a systematic review was performed to assess medial UKA failure modes. Furthermore, we compared cohort studies with registry-based studies, early with midterm and late failures and fixed-bearing with mobile-bearing implants. METHODS: Databases of PubMed, EMBASE, and Cochrane and annual registries were searched for medial UKA failures. Studies were included when they reported >25 failures or when they reported early (<5 years), midterm (5-10 years), or late failures (>10 years). RESULTS: Thirty-seven cohort studies (4 level II studies and 33 level III studies) and 2 registry-based studies were included. A total of 3967 overall failures, 388 time-dependent failures, and 1305 implant design failures were identified. Aseptic loosening (36%) and osteoarthritis (OA) progression (20%) were the most common failure modes. Aseptic loosening (26%) was most common early failure mode, whereas OA progression was more commonly seen in midterm and late failures (38% and 40%, respectively). Polyethylene wear (12%) and instability (12%) were more common in fixed-bearing implants, whereas pain (14%) and bearing dislocation (11%) were more common in mobile-bearing implants. CONCLUSION: This level III systematic review identified aseptic loosening and OA progression as the major failure modes. Aseptic loosening was the main failure mode in early years and mobile-bearing implants, whereas OA progression caused most failures in late years and fixed-bearing implants.
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Artroplastia do Joelho/efeitos adversos , Análise de Falha de Equipamento , Articulação do Joelho/cirurgia , Prótese do Joelho/efeitos adversos , Osteoartrite do Joelho/cirurgia , Progressão da Doença , Humanos , Desenho de Prótese , Falha de Prótese , Sistema de Registros , Reoperação , Resultado do TratamentoRESUMO
Anterior locking plate fixation of the distal radius is a common procedure with reliable results. Failure of fixation is sometimes seen. The aim of the present study was to identify the reasons for failure. In total, 517 cases met the study inclusion criteria. Of them, 23 cases had failure of fixation (4.4%). Failure analysis generated qualitative data. Subsequent thematic analysis identified the primary mode of failure and contributing factors. Primary modes were identified as failure to support all key fracture fragments (n = 20), wrong choice of implant (n = 1), failure of union (n = 1) and poor bone quality (n = 1). Contributing factors were errors in plate positioning, fracture reduction, implant selection and screw configuration, as well as fracture pattern complexity and poor bone quality. Most failed fixations had a primary mode and two or three contributing factors. Overall anterior plating is reliable with a low rate of surgical failure. Knowledge of failure modes will aid operative planning and prevent failure.Level of evidence: V.
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Fraturas do Rádio , Rádio (Anatomia) , Humanos , Rádio (Anatomia)/cirurgia , Fraturas do Rádio/cirurgia , Fixação Interna de Fraturas/métodos , Parafusos Ósseos , Placas ÓsseasRESUMO
In recent years, the U.S. Food and Drug Administration (FDA) has seen an increase in microfluidic medical device submissions, likely stemming from recent advancements in microfluidic technologies. This recent trend has only been enhanced during the COVID-19 pandemic, as microfluidic-based test kits have been used for diagnosis. To better understand the implications of this emerging technology, device submissions to the FDA from 2015 to 2021 containing microfluidic technologies have been systematically reviewed to identify trends in microfluidic medical applications, performance tests, standards used, fabrication techniques, materials, and flow systems. More than 80% of devices with microfluidic platforms were found to be diagnostic in nature, with lateral flow systems accounting for about 35% of all identified microfluidic devices. A targeted analysis of over 40,000 adverse event reports linked to microfluidic technologies revealed that flow, operation, and data output related failures are the most common failure modes for these device types. Lastly, this paper highlights key considerations for developing new protocols for various microfluidic applications that use certain analytes (e.g., blood, urine, nasal-pharyngeal swab), materials, flow, and detection mechanisms. We anticipate that these considerations would help facilitate innovation in microfluidic-based medical devices.
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Three groups of zirconia abutments (n = 5) consisting of different connection designs or manufacturers were investigated (All-Zr, ASC-Zr, and AM-Zr groups). All-electric dynamic test instruments were used to place static loading on a specimen with a crosshead speed set at 1 mm/min. A Kruskal-Wallis test and a post hoc Mann-Whitney U test were used for statistical evaluation. The mean fracture resistance was 252.37 ± 82.79 N for the All-Zr group, 384.62 ± 45.24 N for ASC-Zr group, and 361.83 ± 90.31 N for the AM-Zr group. The difference of fracture resistance between the three groups was marginally significant (Kruskal-Wallis test, p = 0.054), with the ASC zirconia abutment tending to have higher fracture resistance than the full zirconia abutment. The modes of failure among the three types of abutments are different. The All-Zr group showed an oblique fracture line starting from the buccal aspect at the region of the implant platform. While the ASC-Zr and AM-Zr groups showed a relatively horizontal fracture line with a greater distance from the implant platform. The titanium inserts cannot significantly improve the fracture resistance of the zirconia abutment. However, they may alter the modes of failure, allowing buccal fracture surfaces of the zirconia abutments to be placed away from the implant platform, thereby protecting the implant-abutment connection.
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AIM: To assess bond integrity and modes of failure of metallic brackets to lithium disilicate ceramics (LDC) conditioned with Er,Cr:YSGG laser (ECL). MATERIAL AND METHODS: Sixty LDC were arbitrarily allocated into six groups (n = 15) according to the type of ceramic surface conditioning treatment. Group 1 surface treated with silane (S) only, group 2 surface etched with hydrofluoric acid (HF)+ S, group 3 surface conditioned with HF+ ultrasonic bath (UB)+ S, group 4 sand blasting (SB) of glass ceramic surface with 50 µm Al2O3, group 5 surface conditioned with self-etch ceramic primer (SECP) and in group 6 surface treated with ECL + S. After conditioning, the specimens were positioned in a universal testing device for shear bond strength (SBS) testing. Adhesive Remnant Index (ARI) was used to determine sites of bond failure. Among experimental groups analysis of variance (ANOVA) and Tukey multiple comparison test was used at a significance level of (p < 0.05). RESULTS: The highest SBS values were observed in group 3 HF+ UB + S (18.21 ± 1.241) and the lowest SBS values were displayed group 1 surface treated with S only (5.21 ± 0.23). Specimens surface conditioned in group 2 with HF+ S (17.85 ± 1.25), group 3 HF+ UB + S (18.21 ± 1.241) and group 6 ECL + S (17.09 ± 1.114) unveiled comparable SBS values (p > 0.05). CONCLUSION: LDC conditioned with ECL at (4.5 W and 30 Hz) has a potential to be used in clinical settings alternate to HF acid.
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BACKGROUND: Fractional flow reserve (FFR) measurement is commonly used in the cardiac catheterization laboratory to assess the functional significance of coronary arterial plaques. Robust real-world data on complications and modes of failure of FFR guidewires are limited. AIM: To characterize these outcomes by analyzing the post-marketing surveillance data from the United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database for commonly used FFR guidewires. METHODS: The MAUDE database was queried from January 2010 through April 2020 for 3 FFR guidewires [PressureWireTM X (Abbott), CometTM (Boston Scientific), and VerrataTM (Philips)] by searching for the following events: "Injury", "malfunction", "death", and "other". This yielded 544 reports. After excluding incomplete reports, 486 reports were analyzed. RESULTS: Guidewire tip fracture was the most commonly reported mode of failure, in 174 (35.8%) cases followed by guidewire kinking (n = 152, 31.3%), communication failure (n = 141, 29.0%), and shaft fracture (n = 67, 13.8%). In total, 133 (27.4%) device failures resulted in patient adverse events. The most common adverse event was retained guidewire tip, in 71 (53.4%) cases, followed by freshly deployed stent dislodgment (n = 26, 19.6%) and coronary artery dissection (n = 23, 17.3%). Seven deaths were reported. CONCLUSION: FFR guidewire failures can occur because of various mechanisms and cause patient adverse events. The MAUDE database serves as an important platform for improved collaboration among clinicians, device manufacturers, and regulators to improve device performance and optimize patient outcomes. Our analysis provides mechanistic insights of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.
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BACKGROUND: To evaluate the effect of different photosensitizer on extrusion bond strength of glass fiber post to radicular dentin. MATERIAL AND METHODS: Forty maxillary and mandibular central incisors were disinfected and decoronated. Mechanical instrumentation of canal was performed using protaper NiTi. Shaping and cleaning of canal comprised of S1, S2, SX with finishing files F1 and F2, followed by continuous irrigation. Canals were dried and obturated with gutta percha. Peso reamers were used to prepare post space. Based on the photosensitizers (PS) used, the samples were divided into three groups (nâ¯=â¯10). Group 1: treated with methylene blue photosensitizer (MBP) at 50â¯mg/l, Group 2: Curcumin photosensitizer (CP) at 500â¯mg/l, Group 3: canal space was filled with Toluidine blue photosensitizer (TB) at 100â¯mg/l. All photosensitizers were activated using different lasers. The samples in group 4 (control) were irrigated using 5.25% sodium hypochlorite (NaOCl) + 17% ethylenediamine tetra acetic acid (EDTA). Posts were cemented and teeth were sectioned into coronal, middle and apical sections. All sections were placed in universal testing machine to evaluate extrusion bond strength in megapascal (MPa). Fracture pattern analysis of samples were seen under stereomicroscope at 50x magnification and categorized into adhesive, cohesive and admixed. Assessment of extrusion bond strength was performed by one-way analysis of variance (ANOVA) and Tukey multiple comparison test (pâ¯=â¯0.05). RESULTS: The highest bond strength was achieved in group 2, including samples treated with curcumin photosensitizer (CP) at all three root levels; cervical (9.01⯱â¯1.62â¯MPa), middle (7.95⯱â¯0.75â¯MPa) and apical (5.81⯱â¯0.15â¯MPa). Whereas, the lowest extrusion bond strength was observed in group 4 (canal irrigated with conventional 5.25% NaOCl +17% EDTA) at coronal (6.10⯱â¯1.77â¯MPa), middle (5.11⯱â¯0.75â¯MPa) and apical one-thirds (3.65⯱â¯0.14â¯MPa). Intra group comparison revealed decrease in extrusion bond strength from coronal to apical direction. Moreover, both group 2 and group 3 showed statistically significant difference to samples in control group and group 1. (pâ¯<â¯0.05). CONCLUSION: TB and CP at concentration of 100â¯mg/l and 500â¯mg/l has the potential to be used as an alternate to conventional cleaning regime. TB and CP at this concentration when activated with PDT is likely to improve extrusion bond values.
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Fotoquimioterapia , Fármacos Fotossensibilizantes , Dentina , Guta-Percha , Teste de Materiais , Fotoquimioterapia/métodosRESUMO
AIMS: Limited evidence is available on mid-term outcomes of robotic-arm assisted (RA) partial knee arthroplasty (PKA). Therefore, the purpose of this study was to evaluate mid-term survivorship, modes of failure, and patient-reported outcomes of RA PKA. METHODS: A retrospective review of patients who underwent RA PKA between June 2007 and August 2016 was performed. Patients received a fixed-bearing medial or lateral unicompartmental knee arthroplasty (UKA), patellofemoral arthroplasty (PFA), or bicompartmental knee arthroplasty (BiKA; PFA plus medial UKA). All patients completed a questionnaire regarding revision surgery, reoperations, and level of satisfaction. Knee Injury and Osteoarthritis Outcome Scores (KOOS) were assessed using the KOOS for Joint Replacement Junior survey. RESULTS: Mean follow-up was 4.7 years (2.0 to 10.8). Five-year survivorship of medial UKA (n = 802), lateral UKA (n = 171), and PFA/BiKA (n = 35/10) was 97.8%, 97.7%, and 93.3%, respectively. Component loosening and progression of osteoarthritis (OA) were the most common reasons for revision. Mean KOOS scores after medial UKA, lateral UKA, and PFA/BiKA were 84.3 (SD 15.9), 85.6 (SD 14.3), and 78.2 (SD 14.2), respectively. The vast majority of the patients reported high satisfaction levels after RA PKA. Subgroup analyses suggested tibial component design, body mass index (BMI), and age affects RA PKA outcomes. Five-year survivorship was 98.4% (95% confidence interval (CI) 97.2 to 99.5) for onlay medial UKA (n = 742) and 99.1% (95% CI 97.9 to 100) for onlay medial UKA in patients with a BMI < 30 kg/m2 (n = 479). CONCLUSION: This large single-surgeon study showed high mid-term survivorship, satisfaction levels, and functional outcomes in RA UKA using metal-backed tibial onlay components. In addition, favourable results were reported in RA PFA and BiKA. Cite this article: Bone Joint J 2020;102-B(1):108-116.
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Artroplastia do Joelho/estatística & dados numéricos , Prótese do Joelho/estatística & dados numéricos , Procedimentos Cirúrgicos Robóticos/estatística & dados numéricos , Adulto , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/métodos , Índice de Massa Corporal , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/cirurgia , Medidas de Resultados Relatados pelo Paciente , Falha de Prótese , Reoperação/estatística & dados numéricos , Estudos RetrospectivosRESUMO
Quantitative landslide risk analysis is a key step in creating appropriate land use policies. However, regional scale landslide hazard and risk studies are traditionally based on a single, infinite-slope style of failure, belying the differing consequences of a diverse range of failure modes. In this paper we expand an existing multimodal coseismic landslide hazard model to create a method for multimodal, multi-trigger quantitative landslide risk analysis and apply it to the country of Lebanon. â¢Physics-based, mode-specific models for coseismic and precipitation-induced landslides capture the effects of multiple failure types and triggering scenarios.â¢A new model for analyzing slope stability against rotational failures allows for efficient, regional scale assessments.â¢Open-source mapping of built-up area is used to identify elements at risk.
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BACKGROUND/PURPOSE: Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints. MATERIALS/METHODS: The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis. RESULTS: In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%). CONCLUSIONS: Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF.
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Insuficiência Cardíaca/terapia , Coração Auxiliar , Vigilância de Produtos Comercializados , Falha de Prótese , Disfunção Ventricular Direita/terapia , Função Ventricular Direita , Bases de Dados Factuais , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Desenho de Prótese , Fatores de Risco , Fatores de Tempo , Disfunção Ventricular Direita/diagnóstico , Disfunção Ventricular Direita/etiologia , Disfunção Ventricular Direita/fisiopatologiaRESUMO
AIMS: Joint-preserving surgery of the hip (JPSH) has evolved considerably and now includes a number of procedures, including arthroscopy, surgical dislocation, and redirectional osteotomies of the femur and acetabulum. There are a number of different factors which lead to failure of JPSH. Consequently, it is of interest to assess the various modes of failure in order to continue to identify best practice and the indications for these procedures. PATIENTS AND METHODS: Using a retrospective observational study design, we reviewed 1013 patients who had undergone JPSH by a single surgeon between 2005 and 2015. There were 509 men and 504 women with a mean age of 39 years (16 to 78). Of the 1013 operations, 783 were arthroscopies, 122 surgical dislocations, and 108 peri-acetabular osteotomies (PAO). We analysed the overall failure rates and modes of failure. Re-operations were categorised into four groups: Mode 1 was arthritis progression or organ failure leading to total hip arthroplasty (THA); Mode 2 was an Incorrect diagnosis/procedure; Mode 3 resulted from malcorrection of femur (type A), acetabulum (type B), or labrum (type C) and Mode 4 resulted from an unintended consequence of the initial surgical intervention. RESULTS: At a mean follow-up of 2.5 years, there had been 104 re-operations (10.2%) with a mean patient age of 35.5 years (17 to 64). There were 64 Mode 1 failures (6.3%) at a mean of 3.2 years following JPSH with a mean patient age of 46.8 years (18 to 64). There were 17 Mode 2 failures (1.7%) at a mean of 2.2 years post-JPSH with a mean patient age of 28.9 years (17 to 42) (2% scopes; 1% surgical dislocations). There were 19 Mode 3 failures (1.9%) at a mean of 2.0 years post-JPSH, with a mean patient age of 29.9 years (18 to 51) (2% scopes; 2% surgical dislocations; 5% PAO). There were 4 Mode 4 failures (0.4%) at a mean of 1.8 years post-JPSH with a mean patient age of 31.5 years (15 to 43). Using the modified Dindo-Clavien classification system, the overall complication rate among JPSHs was 4.2%. CONCLUSION: While defining the overall re-operation and complication rates, it is important to define the safety and effectiveness of JPSH. Standardisation of the modes of failure may help identify the best practice. Application of these modes to large clinical series, such as registries, will assist in further establishing how to improve the efficacy of JPSH. Cite this article: Bone Joint J 2017;99-B:303-9.
Assuntos
Acetábulo/cirurgia , Osteoartrite do Quadril/cirurgia , Adolescente , Adulto , Idoso , Artroplastia de Quadril , Artroscopia/efeitos adversos , Artroscopia/métodos , Progressão da Doença , Feminino , Fêmur/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Osteotomia/efeitos adversos , Osteotomia/métodos , Reoperação/efeitos adversos , Reoperação/métodos , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Falha de Tratamento , Adulto JovemRESUMO
The term mid-flexion instability has entered the orthopaedic literature as a concept, but has not been confirmed as a distinct clinical entity. The term is used freely, sometimes as a synonym for flexion instability. However, the terms need to be clearly separated. A cadaver study published in 1990 associated joint line elevation with decreased stability at many angles of flexion, but that model was not typical of clinical scenarios. The literature is considered and it is proposed that the more common entity of an uncorrected flexion contracture after a measured resection arthroplasty technique is more likely to produce clinical findings that suggest instability mid-flexion. It is proposed that the clinical scenario encountered is generalised instability, with the appearance of stability in full extension from tight posterior structures. This paper seeks to clarify whether mid-flexion instability exists as an entity distinct from other commonly recognised forms of instability.
Assuntos
Artroplastia do Joelho/efeitos adversos , Instabilidade Articular/etiologia , Humanos , Instabilidade Articular/fisiopatologia , Amplitude de Movimento ArticularRESUMO
There are many reasons why a total knee replacement (TKR) may fail and qualify for revision. Successful revision surgery depends as much on accurate assessment of the problem TKR as it does on revision implant design and surgical technique. Specific modes of failure require specific surgical solutions. Causes of failure are often presented as a list or catalogue, without a system or process for making a decision. In addition, strict definitions and consensus on modes of failure are lacking in published series and registry data. How we approach the problem TKR is an essential but neglected aspect of understanding knee replacement surgery. It must be carried out systematically, comprehensively and efficiently. Eight modes of failure are described: 1) sepsis; 2) extensor discontinuity; 3) stiffness; 4) tibial- femoral instability; 5) patellar tracking; 6) aseptic loosening and osteolysis; 7) periprosthetic fracture and 8) component breakage. A ninth 'category', unexplained pain is an indication for further investigation but not surgery.