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1.
Chemosphere ; 329: 138531, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37004818

RESUMO

Water is an essential resource for humans, animals, and plants. Water is also necessary for the manufacture of many products such as milk, textiles, paper, and pharmaceutical composites. During manufacturing, some industries generate a large amount of wastewater containing numerous contaminants. In the dairy industry, for each litre of drinking milk produced, about 10 L of wastewater is generated. Despite this environmental footprint, the production of milk, butter, ice cream, baby formula, etc., are essential in many households. Common contaminants in dairy wastewater include high biological oxygen demand (BOD), chemical oxygen demand (COD), salts as well as nitrogen and phosphorus derivatives. Nitrogen and phosphorus discharges are one of the leading causes in the eutrophication of rivers and oceans. Porous materials have long held significant potential as a disruptive technology for wastewater treatment. However, thus far they have been understudied for use in dairy wastewater treatment. Ordered porous materials, such as zeolites and metal organic frameworks (MOFs), represent classes of porous materials with significant potential for the removal of nitrogen and phosphorus. This review explores the different zeolites and MOFs applied in the removal of nitrogen and phosphorus from wastewater and the prospect of their potential for use in wastewater management in the dairy industry.


Assuntos
Estruturas Metalorgânicas , Purificação da Água , Zeolitas , Animais , Humanos , Águas Residuárias , Fósforo , Nitrogênio/análise , Purificação da Água/métodos , Água , Eliminação de Resíduos Líquidos/métodos
2.
Int J Spine Surg ; 15(s2): S56-S64, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34675030

RESUMO

Robotic-assisted adult deformity surgery has played a rapidly expanding role since its introduction. As robotic spine technologies improve, the potential to limit complications and morbidity is vast. The improvements in instrumentation accuracy combined with the ability to maintain that accuracy in multiple positions allow creative surgical approaches and techniques that can limit operative time, blood loss, and improve outcomes. In the years to come, robotic-assisted spine surgery and navigation will likely play an expanding role that continues to be defined. LEVEL OF EVIDENCE: 5, expert opinion.

3.
Arthrosc Sports Med Rehabil ; 3(6): e1899-e1904, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34977646

RESUMO

PURPOSE: Evidenced-based decision-making is rooted in comparative clinical studies; however, a small number of outcome event reversals have the potential to change study significance. The purpose of this study was to determine the utility of applying fragility analysis to comparative studies in the published orthopaedic shoulder literature. METHODS: Comparative clinical shoulder research studies reporting 1:1 dichotomous categorical data were analyzed in 6 leading orthopaedic journals between 2006 and 2016. Statistical significance was defined as a P value of less than .05. The fragility index (FI) for each study outcome was determined by the number of event reversals required to change the P value to either greater or less than 0.05, thus changing the study conclusions. The associated fragility quotient (FQ) was determined by dividing the FI by the total population comprising a particular outcome. RESULTS: Of the 23,897 studies screened, 3,591 met search criteria, with 198 comparative studies ultimately included for analysis, 67 of which were randomized controlled trials. There were 357 total outcome events with 74 reported as significant and 283 as not significant. The FI was 4 (IQR 2-6) with an associated FQ of 0.066 (interquartile range [IQR] 0.038-0.102). There was no difference in statistical fragility between randomized and nonrandomized trials with both revealing a FI of 4 and FQ of 0.068 (IQR 0.044-0.107) and 0.065 (IQR 0.031-0.101), respectively. CONCLUSIONS: This current analysis reveals that comparative shoulder studies published in six leading orthopaedic journals are at risk of statistical fragility. As such, contemporary clinical shoulder literature may not be as robust as traditionally perceived with the reversal of only a few outcome events required to change study significance. Therefore, we advocate the reporting of both FI and FQ in addition to the P value as statistical complements to all comparative investigations to provide a more comprehensive understanding of trial stability and significance in the published shoulder literature. CLINICAL RELEVANCE: Comparative study designs are commonly employed in shoulder research. Several studies in both the general medical and orthopaedic literature have identified a lack of statistical robustness through comprehensive fragility analysis. Our findings demonstrate the P value may be an inadequate independent statistical metric requiring the complement of a FI and FQ to aid in the interpretation and understanding of study significance for clinical decision-making.

4.
Spine (Phila Pa 1976) ; 45(15): E959-E966, 2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32675612

RESUMO

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To develop a comprehensive understanding of the prognostic value of laboratory markers on morbidity and mortality following epidural abscess. SUMMARY OF BACKGROUND DATA: Spinal epidural abscess is a serious medical condition with high rates of morbidity. The value of laboratory data in forecasting morbidity and mortality after epidural abscess remains underexplored. METHODS: We obtained clinical data on patients treated for epidural abscess at two academic centers from 2005 to 2017. Our primary outcome was the development of one or more complications within 90-days of presentation, with mortality a secondary measure. Primary predictors included serum albumin, serum creatinine, platelet-lymphocyte ratio, and ambulatory status at presentation. We used multivariable logistic regression techniques to adjust for confounders. The most parsimonious set of variables influencing both complications and mortality were considered to be clinically significant. These were then examined individually and in combination to assess for synergy along with model-discrimination and calibration. We performed internal validation with a bootstrap procedure using sampling with replacement. RESULTS: We included 449 patients in this analysis. Complications were encountered in 164 cases (37%). Mortality within 1-year occurred in 39 patients (9%). Regression testing determined that serum albumin, serum creatinine, and ambulatory status at presentation were clinically important predictors of outcome, with albumin more than 3.5 g/dL, creatinine less than or equal to 1.2 mg/dL, and independent ambulatory function at presentation considered favorable characteristics. Patients with no favorable findings had increased likelihood of 90-day complications (odds ratio [OR] 5.43; 95% confidence intervals [CI] 1.98, 14.93) and 1-year mortality (OR 8.94; 95% CI 2.03, 39.37). Those with one favorable characteristic had greater odds of complications (OR 4.00; 95% CI 2.05, 7.81) and mortality (OR 5.71; 95% CI 1.60, 20.43). CONCLUSION: We developed a nomogram incorporating clinical and laboratory values to prognosticate outcomes after treatment for epidural abscess. The results can be used in shared-decision making and counseling. LEVEL OF EVIDENCE: 3.


Assuntos
Abscesso Epidural/sangue , Abscesso Epidural/mortalidade , Limitação da Mobilidade , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/mortalidade , Adulto , Idoso , Biomarcadores/sangue , Estudos de Coortes , Abscesso Epidural/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Morbidade/tendências , Mortalidade/tendências , Prognóstico , Estudos Retrospectivos
5.
ACS Appl Mater Interfaces ; 12(30): 33759-33764, 2020 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-32497420

RESUMO

Physisorbent metal-organic materials (MOMs) have shown benchmark performance for highly selective CO2 capture from bulk and trace gas mixtures. However, gas stream moisture can be detrimental to both adsorbent performance and hydrolytic stability. One of the most effective methods to solve this issue is to transform the adsorbent surface from hydrophilic to hydrophobic. Herein, we present a facile approach for coating MOMs with organic polymers to afford improved hydrophobicity and hydrolytic stability under humid conditions. The impact of gas stream moisture on CO2 capture for the composite materials was found to be negligible under both bulk and trace CO2 capture conditions with significant improvements in regeneration times and energy requirements.

6.
Foot Ankle Spec ; 13(4): 351-355, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32306750

RESUMO

The use of suture button (SB) devices in the treatment of syndesmotic ankle injuries is increasing. These constructs have demonstrated better syndesmotic reduction, improved clinical outcomes, and lower rates of hardware removal compared with screw fixation. However, placing a SB device without a fibular plate can be technically challenging. In this technique tip, we use an illustrative case to demonstrate a technique tip that minimizes the risk of anterior or posterior cortical breach of the fibula and helps facilitate more accurate placement of a SB device.Levels of Evidence: Level V: Expert opinion.


Assuntos
Traumatismos do Tornozelo/cirurgia , Fíbula , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/prevenção & controle , Procedimentos Ortopédicos/métodos , Âncoras de Sutura/efeitos adversos , Técnicas de Sutura , Adulto , Feminino , Humanos , Procedimentos Ortopédicos/efeitos adversos , Técnicas de Sutura/efeitos adversos
7.
Injury ; 51(6): 1392-1396, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32268964

RESUMO

INTRODUCTION: Determining deltoid ligament incompetence in supination external rotation (SER) injuries commonly relies on stress radiography, given several studies demonstrating low predictive value of physical examination. Stress radiography can be difficult to obtain and may result in suboptimal radiographs with equivocal determination of stability. This study revisits the concept of medial ankle tenderness and its association with mortise instability. METHODS: Patients who presented with an isolated lateral malleolus fracture underwent prospective data collection. VAS scores were recorded with palpation at the lateral malleolar fracture site, anterior deltoid ligament, and posterior deltoid ligament. Three non-weightbearing radiographs of the ankle and a gravity stress view were obtained. Statistical analysis was performed to determine a correlation between tenderness and instability defined as MCS widening > 4 mm on gravity stress x-ray. RESULTS: 51 patients met inclusion criteria. Group I (stable) and Group II (unstable) demonstrated no difference in tenderness over the lateral malleolus (p = 0.94) or anterior deltoid (p = 0.12), but patients in Group II reported significantly more tenderness over the posterior deltoid (p = 0.03). Taking the higher pain score from either anterior or posterior deltoid palpation, patients with unstable ankle fractures reported significantly more tenderness with medial palpation (p = 0.02). The relative risk of having an unstable ankle fracture with any tenderness to palpation over either the anterior or posterior deltoid ligament was 1.77 (95% CI 1.03 - 3.06, P = 0.039). When comparing no pain versus the presence of any pain with palpation medially, the sensitivity for any medial tenderness to detect an unstable ankle fracture was 0.76 (specificity 0.59, PPV 0.79, NPV 0.56). CONCLUSION: Patients with any medial tenderness were at significantly higher risk of having an unstable SER ankle fracture in this study, but strict reliance on the presence or absence of medial tenderness without stress radiographs would lead to an unacceptable number of both false positive and false negative determinations of instability. However, our findings suggest that medial tenderness is associated with instability. The 0.79 PPV of any medial tenderness for instability may be useful to cast doubt on equivocal stress radiography and prompt surgeons to repeat stress radiography or shorten the interval for radiographic follow up. LEVEL OF EVIDENCE: Diagnostic study, Level II-1 (development of diagnostic criteria on basis of consecutive patients [with universally applied reference "gold" standard]).


Assuntos
Fraturas do Tornozelo/fisiopatologia , Instabilidade Articular/fisiopatologia , Ligamentos Articulares/fisiopatologia , Amplitude de Movimento Articular/fisiologia , Supinação/fisiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Fraturas do Tornozelo/diagnóstico por imagem , Feminino , Humanos , Instabilidade Articular/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos Prospectivos , Radiografia , Análise de Regressão , Adulto Jovem
8.
Arch Bone Jt Surg ; 8(1): 99-111, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32090153

RESUMO

Orthopedic implant removal is a commonly performed procedure. While implant removal can be associated with improved symptoms, risks of the surgery are notable. Stripped screws, broken and retained hardware, and morbidity associated with soft tissue compromise during difficult removal are all common. Familiarity with the instruments is critical to procedure success. The purpose of this study is to assist removal of unfamiliar screws in upper extremity surgery by offering a reference for screw and driver compatibility across manufacturers. Inclusion of device manufacturers was determined by market share. Screw size, drive configuration, and screw removal system compatibility data was collected and recorded. Screw, guide-wire, and screwdriver compatibility was assessed and compared to two commonly utilized universal implant-removal sets. Eight upper extremity implant vendors were included. The data was compiled in table format according to manufacturer and sub-categorized to facilitate screw identification according to radiographically identifiable characteristics. The diversity of orthopaedic implants in upper extremity surgery requires careful preoperative planning to identify the appropriate equipment for implant removal. The goal of this work is to provide a centralized reference of commonly implanted screws, guide-wires, and drivers for the upper extremity to facilitate removal.

9.
J Orthop Trauma ; 34(3): 126-130, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32084089

RESUMO

OBJECTIVES: To determine whether a particular surgical approach or combination of approaches is a risk factor for infection. DESIGN: Retrospective review. SETTING: Two Level-1 trauma centers. PATIENTS/PARTICIPANTS: Five hundred ninety pilon fractures in 581 patients (66% male) with a median age of 45 years were identified. INTERVENTION: Open reduction internal fixation of pilon fractures. MAIN OUTCOME MEASURES: Postoperative deep surgical site infection and risk factors for postoperative deep infection. RESULTS: The most common primary surgical approach was medial (54%), followed by anterolateral (25%), anteromedial (11%), posterolateral (8%), and posteromedial (2%). A dual approach to the distal tibia was used in 18% of the cases. The overall deep infection rate was 19%. There was no association between primary surgical approach and development of infection (P = 0.19-0.78). Independent risk factors for infection were smoking (hazard ratio, 2.1; P < 0.001) and need for soft tissue coverage (hazard ratio, 6.9; P < 0.001). CONCLUSIONS: Surgical approach does not appear to be a significant risk factor for postoperative infection after open reduction internal fixation of distal tibial pilon fractures. When treating tibial plafond fractures, surgeons should select the approach they feel best addresses the specific fracture pattern. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Fraturas do Tornozelo , Fraturas da Tíbia , Feminino , Fixação Interna de Fraturas/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fraturas da Tíbia/diagnóstico por imagem , Fraturas da Tíbia/cirurgia , Resultado do Tratamento
10.
OTA Int ; 3(2): e054, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33937694

RESUMO

OBJECTIVES: Evaluate the correlation between aortic stenosis and perioperative mortality in patients following surgical fixation of proximal femur fractures. DESIGN: Retrospectively reviewed case series. SETTING: Two Academic, Level 1 Trauma Centers. PATIENTS/PARTICIPANTS: One hundred fifty-eight patients, definitively diagnosed with aortic stenosis by means of echocardiogram, who underwent surgical fixation for an isolated proximal femur fracture (OTA/AO 31-A, 31-B, 32-A, 32-B, and 32-C fractures) between January 2000 and June 2015. The severity of the aortic stenosis was based upon accepted echocardiographic hemodynamic parameters designated by the 2014 American Heart Association guidelines. MAIN OUTCOME MEASURES: Post Injury mortality, 30-day mortality, and 1-year mortality. SECONDARY OUTCOME MEASURES: Postoperative mortality stratified by severity of aortic stenosis based on aortic valve area (AVA) and ejection fracture (EF) as determined by preoperative echocardiography. RESULTS: One hundred fifty-eight patients were available for final analysis. Kaplan-Meier survival analysis revealed a significantly longer time to mortality among Non-severe aortic stenosis patients compared to Severe aortic stenosis patients, P value .006. Twenty-three percent of patients with Severe aortic stenosis and 10% of patients with Non-severe aortic stenosis died within 30 days of surgery. No significant difference was observed in mean survival among AS patients who underwent surgery within 48 hours of injury (34.5 months) and those delayed more than 48 hours after injury (25.0 months), P value .116. Among the commonly measured hemodynamic parameters of aortic stenosis, only AVA and EF were significantly associated with mortality, P value .015, and P value < .001, respectively. There were no significant effects for Aortic Vmax, Peak ΔP, and Mean ΔP. An AVA of 0.8 cm2 or less is associated with a significantly shorter (22 months) postinjury mortality than patients with an AVA > 0.8 cm2. (37 months), P value .009. CONCLUSIONS: Severe aortic stenosis is associated with a shorter postoperative time to mortality after surgical fixation of hip fractures compared to patients with Non-severe stenosis. Aortic valve area and Ejection Fraction are the only hemodynamic parameters significantly associated with postoperative mortality.Level of Evidence: Prognostic Level III.

11.
Foot Ankle Spec ; 13(5): 397-403, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31353946

RESUMO

Background. Syndesmotic disruption occurs in 20% of ankle fractures and requires anatomical reduction and stabilization to maximize outcomes. Although screw breakage is often asymptomatic, the breakage location can be unpredictable and result in painful bony erosion. The purpose of this investigation is to report early clinical and radiographic outcomes of patients who underwent syndesmotic fixation using a novel metal screw designed with a controlled break point. Methods. We performed a retrospective review of all patients who underwent syndesmotic fixation utilizing the R3lease Tissue Stabilization System (Paragon 28, Denver, CO) over a 12-month period. Demographic and screw-specific data were obtained. Postoperative radiographs were reviewed, and radiographic parameters were measured. Screw loosening or breakage was documented. Results. 18 patients (24 screws) met inclusion criteria. The mean follow-up was 11.7 months (range = 6.0-14.7 months). 5/24 screws (21%) fractured at the break point. No screw fractured at another location, nor did any fracture prior to resumption of weight bearing; 19 screws did not fracture, with 8/19 intact screws (42.1%) demonstrating loosening. There was no evidence of syndesmotic diastasis or mortise malalignment on final follow-up. No screws required removal during the study period. Conclusion. This study provides the first clinical data on a novel screw introduced specifically for syndesmotic fixation. At short-term follow up, there were no complications and the R3lease screw provided adequate fixation to allow healing and prevent diastasis. Although initial results are favorable, longer-term follow-up with data on cost comparisons and rates of hardware removal are needed to determine cost-effectiveness relative to similar implants.Level of Evidence: Level IV: Retrospective case series.


Assuntos
Fraturas do Tornozelo/diagnóstico por imagem , Fraturas do Tornozelo/cirurgia , Articulação do Tornozelo/diagnóstico por imagem , Articulação do Tornozelo/cirurgia , Parafusos Ósseos/efeitos adversos , Falha de Equipamento/estatística & dados numéricos , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/métodos , Adolescente , Adulto , Idoso , Remoção de Dispositivo/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
12.
Pharmacotherapy ; 39(10): 983-993, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31411763

RESUMO

STUDY OBJECTIVE: Iron deficiency anemia is the most common form of anemia, and parenteral iron therapy is necessary in select patients. The objective of this analysis was to assess the impact of initial complete parenteral iron repletion on serum hemoglobin (Hgb) level normalization and on health care resource utilization in real-world practice. DESIGN: Retrospective observational study. DATA SOURCE: Decision Resources Group Real-World Data Repository (United States databases). PATIENTS: A total of 2966 patients who had a baseline Hgb level below normal (< 12 g/dl for females and < 13.5 g/dl for males) and were treated with parenteral iron between March 2015 and February 2017. MEASUREMENTS AND MAIN RESULTS: The effect of receiving the required parenteral iron dose to replete the deficit, calculated by a modified Ganzoni formula, within 3 weeks of the first parenteral iron therapy claim (index date) on the likelihood of Hgb level normalization, was estimated by using logistic regression. All analyses were adjusted for sex, age, comorbidities, and use of prescription oral iron therapy. The adjusted mean numbers of all-cause inpatient admissions, outpatient visits, and emergency department (ED) visits within 6 months and 1 year after the index date were compared between patients with and without normalized Hgb levels by using negative binomial regression. Of the 2966 included patients, 33.9% received the required iron dose within 3 weeks of the index date, and 19.6%, 48.2%, and 53.9% had a normalized Hgb level within 8 weeks of the index date, within 1 year of the index date, and until the end of data availability, respectively. Patients who received the required iron dose within 3 weeks of the index date were significantly more likely to have a normalized Hgb level within 8 weeks of the index date and at any time during the study period than those who did not: adjusted odds ratio (OR) (95% confidence interval [CI]) 2.67 (2.20, 3.24) and 2.33 (1.96, 2.77), respectively. Hgb level normalization within 1 year of the index date was associated with fewer inpatient admissions and outpatient visits and a similar number of ED visits compared with no Hgb level normalization 1 year after the index date. CONCLUSION: The results of these analyses underscore the importance of initial complete parenteral iron repletion for rapidly improving clinical outcomes. Prompt achievement of a normalized Hgb level may also provide an opportunity to reduce health care resource utilization in patients with iron deficiency anemia receiving parenteral iron therapy.


Assuntos
Anemia Ferropriva , Hemoglobinas/análise , Infusões Parenterais/métodos , Ferro/administração & dosagem , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Anemia Ferropriva/sangue , Anemia Ferropriva/diagnóstico , Anemia Ferropriva/tratamento farmacológico , Relação Dose-Resposta a Droga , Monitoramento de Medicamentos/métodos , Feminino , Fármacos Hematológicos/administração & dosagem , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento
13.
J Orthop Trauma ; 33(12): e466-e470, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31356443

RESUMO

OBJECTIVES: To evaluate the stability of statistical findings in the fracture care literature based on minor changes in event rates and to determine the utility of applying both the Fragility Index (FI) and Fragility Quotient (FQ) to comparative orthopaedic trauma trials. METHODS: All fracture care studies from 1991 to 2013 in the Journal of Bone and Joint Surgery and the Journal of Orthopaedic Trauma were screened. The FI was determined by altering the number of reported outcome events, a single event at time, until a reversal of statistical significance was determined. The associated FQ was determined by dividing the FI by the total sample size. RESULTS: Of the 4040 studies evaluated, 198 comparative studies met inclusion criteria with a reported 253 primary and 522 secondary outcome events. There were 118 randomized controlled trials and 80 retrospective comparative studies. Of the 775 total outcome events, 235 were initially reported as significant. The median FI for the entire study was only 5 with an associated FQ of 0.046. This represents just 3.8% of the total study population. CONCLUSIONS: The robustness of comparative trials in the orthopaedic trauma literature may not be as stable as previously thought with only a few event reversals required to alter trial significance. We therefore recommend triple reporting of a P value, FI, and FQ to aid in the evaluation and interpretation of statistical stability and quantitative significance in comparative orthopaedic trauma trials.


Assuntos
Pesquisa Biomédica/organização & administração , Interpretação Estatística de Dados , Fraturas Ósseas/complicações , Fraturas Ósseas/cirurgia , Fragilidade/complicações , Ensaios Clínicos como Assunto , Estudos de Coortes , Humanos , Reprodutibilidade dos Testes
14.
Int J Pharm ; 566: 615-630, 2019 Jul 20.
Artigo em Inglês | MEDLINE | ID: mdl-31158454

RESUMO

In this work, the transfer of oral solid dosage forms, currently manufactured via wet granulation, to a continuous direct compression process was considered. Two main challenges were addressed: (1) a poorly flowing API (Canagliflozin) and (2) high drug loading (51 wt%). A scientific approach was utilised for formulation development, targeting flow and compaction behaviour suitable for manufacturing scale. This was achieved through systematic screening of excipients to identify feasible formulations. Targeted design of experiments based on factors such as formulation mixture and processing parameters were utilised to investigate key responses for tablet properties, flow and compaction behaviour. Flow behaviour was primarily evaluated from percentage compressibility and shear cell testing on a powder flow rheometer (FT4). The compaction behaviour was studied using a compaction simulator (Gamlen). The relationships between tablet porosity, tensile strength and compaction pressure were used to evaluate tabletability, compactibility and compressibility to assess scale-up. The success of this design procedure is illustrated by scaling up from the compaction simulator to a Riva Piccola rotary tablet press, while maintaining critical quality attributes (CQAs). Compactibility was identified as a suitable scale-up relationship. The developed procedure should allow accelerated development of formulations for continuous direct compression.


Assuntos
Composição de Medicamentos/métodos , Canagliflozina/química , Excipientes/química , Tamanho da Partícula , Porosidade , Pós , Reologia , Comprimidos , Resistência à Tração
15.
Spine J ; 19(9): 1490-1497, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31125694

RESUMO

BACKGROUND CONTEXT: Emerging literature has identified the importance of pretreatment health and functional status as influential in the prognostication of survival. A comprehensive, accessible, predictive model for survival following cervical spine fracture has yet to be developed. PURPOSE: To develop an accessible and intuitive predictive model for survival in individuals aged 50 and older treated for cervical spine fractures. STUDY DESIGN: Retrospective review of records from two tertiary care centers (2009-2016). PATIENT SAMPLE: Patients age 50 and older who received operative or nonoperative management for cervical fractures. OUTCOME MEASURES: One-year mortality was the primary outcome with 3-month and 2-year mortality considered secondarily. METHODS: Multivariable logistic regression was used to identify factors independently associated with mortality. The magnitude and precision of the relationship with 1-year mortality for statistically significant variables determined weighting in the scoring system subsequently developed. Score performance was tested through multivariable regression and bootstrap simulation. In a sensitivity test, the performance of the score developed for 1-year mortality was assessed using figures for the 3-month and 2-year time-points. RESULTS: We included 1,758 patients. Mortality rates were 12% at 3 months, 17% at 1 year, and 21% at 2 years. Following multivariable testing age, injury severity score and Glasgow coma scale demonstrated the strongest predictive values for a base score, followed by serum albumin and ambulatory status. The resultant composite score ranged from 0 (base score≤4, albumin≤3.5 g/dL, and dependent/nonambulator at presentation) to a maximum of 4 (base score≥5, albumin>3.5 g/dL, and independent ambulator at presentation). Following multivariable analysis, when compared to patients with a score of 4, significantly increased odds of 1-year mortality were appreciated for those with scores of 3 (odds ratio [OR] 7.35; 95% confidence interval [CI] 3.77, 14.32), 2 (OR 8.43; 95% CI 4.66, 15.25), 1 (OR 17.47; 95% CI 9.81, 31.11), and 0 (OR 26.58; 95% CI 13.87, 50.92). Score performance was unchanged in bootstrap testing and sensitivity analyses. CONCLUSIONS: We have developed a useful prognostic utility capable of informing survival in individuals age 50 and older, following cervical spine fractures. The score can be applied to adjust patient expectations, anticipate outcomes, and as an adjunct to decision-making in the postinjury period.


Assuntos
Escala de Gravidade do Ferimento , Fraturas da Coluna Vertebral/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Prognóstico , Fraturas da Coluna Vertebral/patologia , Taxa de Sobrevida
16.
J Orthop Trauma ; 33(3): 116-119, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30779723

RESUMO

OBJECTIVES: To report on the final displacement after in situ percutaneous pinning for Garden type 1 and 2 fractures in height, femoral neck fracture collapse, and loss of offset. DESIGN: Retrospectively reviewed case series. SETTING: Three Academic Medical Centers. Boston University Medical Center (Level 1 Trauma Center), Lahey Hospital and Medical Center (Level 2 Trauma Center), and Geisinger Medical Center (level 2 Trauma Center). PATIENTS/PARTICIPANTS: One hundred thirty skeletally mature patients with 130 fractures (78 garden 1 and 52 garden 2) who were treated between January 2000 and January 2014 at participating hospitals with percutaneous pinning with a cannulated screw system to successful union after sustaining an intracapsular femoral neck fracture without complete displacement. INTERVENTION: In situ percutaneous pinning with 3 cannulated, partially threaded screws in an inverted triangle orientation. MAIN OUTCOME MEASUREMENTS: Femoral neck fracture collapse (mm), femoral height shortening (mm), and femoral offset shortening (mm). RESULTS: A total of 130 patients (81F, 49M), average age 72 years, sustained 78 Garden 1 and 52 Garden 2 femoral neck fractures. Maximal collapse occurred in the plane of the femoral neck. Thirty-three of 78 (42%) Garden 1 fractures and 33/52 (63%) Garden 2 fractures demonstrated >10 mm fracture collapse. The range of displacements was 0-39 mm as measured along the plane of the femoral neck. CONCLUSIONS: Garden 1 fractures collapse less frequently than Garden 2 fractures, but both have high rates of fracture collapse when treated to union with in situ percutaneous pin fixation. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Redução Fechada/efeitos adversos , Fraturas do Colo Femoral/cirurgia , Colo do Fêmur/cirurgia , Fixação de Fratura/efeitos adversos , Fraturas por Compressão/etiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Parafusos Ósseos , Feminino , Fraturas do Colo Femoral/fisiopatologia , Colo do Fêmur/fisiopatologia , Fixação de Fratura/métodos , Consolidação da Fratura , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
17.
Foot Ankle Int ; 40(5): 499-505, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-30654661

RESUMO

BACKGROUND: There is limited evidence that syndesmotic implant removal (SIR) is beneficial. However, many surgeons advocate removal based on studies suggesting improved motion. Methodologic difficulties make the validity and applicability of previous works questionable. The purpose of this study was to examine the effect of ankle dorsiflexion after SIR using radiographically measured motion before and after screw removal utilizing a standardized load. METHODS: All patients undergoing isolated SIR were candidates for inclusion. Dorsiflexion was measured radiographically: (1) immediately before implant removal intraoperatively, (2) immediately after removal intraoperatively, and (3) 3 months after removal. A standardized torque force was applied to the ankle and a perfect lateral radiograph of the ankle was obtained. Four reviewers independently measured dorsiflexion on randomized, deidentified images. A total of 29 patients met inclusion criteria. All syndesmotic injuries were associated with rotational ankle fractures. There were 11 men (38%) and 18 women (62%). The mean, and standard deviation, age was 50.3 ± 16.9 years (range 19-80). RESULTS: The mean ankle dorsiflexion pre-operatively, post-operatively, and at a 3-month follow-up was 13.7 ± 6.6 degrees, 13.3 ± 7.3 degrees and 11.8 ± 11.3 degrees, respectively ( P = .466). For subsequent analysis, 5 patients were excluded because of the potential confounding effect of retained suture button devices. Analysis of the remaining 24 patients (and final analysis of 21 patients who had complete 3-month follow-up) demonstrated similar results with no statistically significant difference in ankle dorsiflexion at all 3 time points. CONCLUSION: Removal of syndesmotic screws may not improve ankle dorsiflexion motion and should not be used as the sole indication for screw removal. LEVEL OF EVIDENCE: Level II, prospective cohort study.


Assuntos
Fraturas do Tornozelo/cirurgia , Traumatismos do Tornozelo/cirurgia , Parafusos Ósseos , Remoção de Dispositivo , Fixação Interna de Fraturas/instrumentação , Amplitude de Movimento Articular , Adulto , Idoso , Traumatismos do Tornozelo/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Radiografia , Adulto Jovem
18.
J Control Release ; 296: 202-224, 2019 02 28.
Artigo em Inglês | MEDLINE | ID: mdl-30664977

RESUMO

Treating diseases of the central nervous system (CNS) is complicated by the presence of the blood-brain barrier (BBB), a semipermeable boundary layer protecting the CNS from toxins and homeostatic disruptions. However, this layer also excludes almost 100% of therapeutics, impeding the treatment of CNS diseases. The advent of nanoparticles, in particular metallic-based nanoparticles, presents the potential to overcome this barrier and transport drugs into the CNS. Recent interest in metallic-based nanoparticles has generated an immense array of information pertaining to nanoparticles of different materials, sizes, morphologies, and surface properties. Nanoparticles with different physico-chemical properties lead to distinct nanoparticle-host interactions; yet, comprehensive characterization is often not completed. Similarly, in vivo testing has involved a mixed evaluation of parameters, including: BBB permeability, integrity, biodistribution, and toxicity. The methods applied to assess these parameters are inconsistent; this complicates the comparison of different nanoparticle-host system responses. A systematic review was conducted to investigate the methods by which metallic-based nanoparticles are characterized and assessed in vivo. The introduction of a standardized approach to nanoparticle characterization and in vivo testing is crucial if research is to transition to a clinical setting. The approach suggested, herein, is based on equipment and techniques that are accessible and informative to facilitate the routine incorporation of this standardized, informative approach into different research settings. Thorough characterization could lead to improved interpretation of in vivo responses, which could clarify nanoparticle properties that result in favorable in vivo outcomes whilst exposing nanoparticle-specific weaknesses. Only then will researchers successfully identify nanoparticles capable of delivering life-saving therapeutics across the blood-brain barrier.


Assuntos
Pesquisa Biomédica/normas , Barreira Hematoencefálica/metabolismo , Portadores de Fármacos/administração & dosagem , Nanopartículas Metálicas/administração & dosagem , Projetos de Pesquisa/normas , Animais , Portadores de Fármacos/farmacocinética
19.
J Am Acad Orthop Surg ; 27(2): e92-e95, 2019 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-30212397

RESUMO

BACKGROUND: Removal of previously placed orthopaedic implants is a commonly performed procedure worldwide. Given the diversity of orthopaedic implant manufacturers, surgeons may be uncertain whether they have the appropriate screwdriver on site. The purpose of this study was to assess the compatibility of screw head and size configurations from various orthopaedic manufacturers with two commonly used universal screw removal sets. METHODS: Inclusion of orthopaedic implant manufacturers was determined by market share based on industry-monitoring financial firms. Screw size and drive type for the top grossing orthopaedic implant manufacturers were collected and recorded. Screw and screwdriver compatibility was assessed and compared with two commonly used universal screw removal sets. RESULTS: In total, six orthopaedic implant companies with commonly implanted screws throughout the appendicular skeleton were included. The data were compiled in table format with noncannulated, cannulated, and locking screw offerings separated by the screw size and manufacturer. Guidewire size compatibility for cannulated offerings was also assessed. CONCLUSIONS: Given the ubiquity of implanted orthopaedic implant, removal must be as safe, planned, and controlled as possible. The data in this article provide an inclusive, centralized resource for surgeons looking to confirm the compatibility of previously implanted screws and available removal equipment at their institution.


Assuntos
Parafusos Ósseos , Remoção de Dispositivo/instrumentação , Planejamento de Assistência ao Paciente , Próteses e Implantes , Humanos , Desenho de Prótese , Estatística como Assunto
20.
Foot Ankle Spec ; 12(1): 79-97, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30132700

RESUMO

BACKGROUND: Orthopaedic surgery frequently requires the use of metal plate and screw constructs for osteosynthesis. These constructs may be subsequently removed for a variety of indications. In the lower extremity in particular, implants (ie, hardware) can lead to prominence and pain secondary to a thin soft-tissue envelope with little subcutaneous tissue. Often, removal is performed without knowledge of the exact type of screw head configuration and/or size, which can make removal technically challenging. The purpose of this study is to consolidate screw head sizes and configurations from commonly utilized orthopaedic foot and ankle implant manufacturers matched against 2 commonly used universal implant removal sets to aid in the expeditious removal of hardware. METHODS: Orthopaedic manufacturers of foot and ankle-specific implants were included based on market share. Publicly available information on screw size, head configuration, and driver size was collected and recorded. This information was cross-referenced against the drivers available in 2 commonly utilized universal implant removal sets. RESULTS: Seven foot and ankle implant manufacturers were included. The data were compiled in table format according to manufacturer and subcategorized by noncannulated screws, cannulated screws, and locking screws. CONCLUSION: Many factors affect the success of hardware removal, and it is imperative that the surgeon knows which drivers are compatible with the implanted hardware. The expanding magnitude and diversity of orthopaedic implants makes removal of hardware more challenging. A guide of compatible drivers for various screw types helps expedite this procedure. LEVELS OF EVIDENCE: Level V.


Assuntos
Tornozelo/cirurgia , Remoção de Dispositivo/métodos , Pé/cirurgia , Procedimentos Ortopédicos/métodos , Cirurgiões Ortopédicos , Procedimentos de Cirurgia Plástica/métodos , Próteses e Implantes , Traumatismos do Tornozelo/cirurgia , Placas Ósseas , Parafusos Ósseos , Humanos , Desenho de Prótese
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