RESUMEN
STUDY DESIGN: This is a narrative review focused on specific challenges related to adequate controls that arise in neuromodulation clinical trials involving perceptible stimulation and physiological effects of stimulation activation. OBJECTIVES: 1) To present the strengths and limitations of available clinical trial research designs for the testing of epidural stimulation to improve recovery after spinal cord injury. 2) To describe how studies can control for the placebo effects that arise due to surgical implantation, the physical presence of the battery, generator, control interfaces, and rehabilitative activity aimed to promote use-dependent plasticity. 3) To mitigate Hawthorne effects that may occur in clinical trials with intensive supervised participation, including rehabilitation. MATERIALS AND METHODS: Focused literature review of neuromodulation clinical trials with integration to the specific context of epidural stimulation for persons with chronic spinal cord injury. CONCLUSIONS: Standard of care control groups fail to control for the multiple effects of knowledge of having undergone surgical procedures, having implanted stimulation systems, and being observed in a clinical trial. The irreducible effects that have been identified as "placebo" require sham controls or comparison groups in which both are implanted with potentially active devices and undergo similar rehabilitative training.
Asunto(s)
Traumatismos de la Médula Espinal , Estimulación de la Médula Espinal , Ensayos Clínicos como Asunto , Espacio Epidural , Humanos , Médula Espinal , Traumatismos de la Médula Espinal/terapiaRESUMEN
OBJECTIVE: Identify the impact of preoperative treatment of Osteoporosis (OP) on reoperation rates, complications and healthcare utilization following thoraco-lumbar (TL) spine fusions. MATERIALS AND METHODS: We used ICD9/10 and CPT codes to extract data from MarketScan (2000-2018). Patients were divided into two groups based on preoperative treatment of OP within one year prior to the index spinal fusion: medication (m-OP) cohort and non-medication (nm-OP) cohort. Outcomes (re-operation rates, re-admission, complications, healthcare utilization) were analyzed at 1-, 12-, 24- and 60-months. RESULTS: Of 3606 patients, 65% (nâ¯=â¯2330) of patients did not receive OP medications (nm-OP). At index hospitalization, there were no difference in LOS (median nm-OP: 3â¯days vs. m-OP:4 days), discharge to home (nm-OP 80% vs. m-OP 75%) and complications (nm-OP 13% vs. m-OP 12%). Reoperation rates were not different among the cohorts at 1- (nm-OP 5.7% vs. m-OP 4.2%), 2- (nm-OP 9.4% vs. m-OP 7.8) and 5â¯years (nm-OP 16.9% vs. m-OP 14.8%). Patients in m-OP cohort incurred higher overall median payments at 1â¯year ($17,866 vs. $ 16,010), 2â¯years ($38,634 vs. $34,454) and 5â¯years ($94,797 vs. $91,072) compared to nm-OP cohort. CONCLUSION: Preoperative treatment of OP had no impact on complications, LOS, discharge disposition following TL fusions at index hospitalization. Similarly, no impact of preoperative treatment was noted in terms of reoperation rates at 12-, 24- and 60â¯months following the index spine fusion. Patients who received preoperative treatment for OP incurred higher health care utilization at 12-, 24- and 60â¯months following surgery.
Asunto(s)
Osteoporosis , Fusión Vertebral , Humanos , Vértebras Lumbares/cirugía , Aceptación de la Atención de Salud , Complicaciones Posoperatorias/epidemiología , Reoperación , Estudios Retrospectivos , Fusión Vertebral/efectos adversosRESUMEN
Malignant cystic lesions in the spine are rare. In this report, we present a 65-year-old man who presented with imbalance on walking of 1-week duration with intact motor examination. Magnetic resonance imaging of the thoracic spine showed large expansile, T2-hyperintense mass involving T8 vertebral body, replacing the posterior elements causing cord compression with associated edema. He underwent uneventful T8 corpectomy, placement of expandable interbody cage, and T5-T11 posterolateral fusion using bilateral transpedicular approach. However, he died 5 months later due to progression of moderately differentiated metastatic lung cancer. To our knowledge, this is the first report showing the near-complete replacement of vertebral body and posterior elements with a malignant cystic lesion.
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Carcinoma de Células Escamosas/secundario , Neoplasias Pulmonares/patología , Neoplasias de la Columna Vertebral/secundario , Anciano , Quistes/patología , Humanos , Masculino , Vértebras TorácicasRESUMEN
OBJECTIVE: To identify factors impacting long-term complications, reoperations, readmission rates, and health care utilization in patients with osteoporosis (OP) following lumbar fusions. METHODS: We used International Classification of Disease, Ninth Revision, International Classification of Disease, Tenth Revision , and Current Procedural Terminology codes to extract data from MarketScan (2000-2016). Patients undergoing lumbar spine fusion were divided into 2 groups based on preoperative diagnosis: OP or non-OP. We used multivariable generalized linear regression models to analyze outcomes of interest (reoperation rates, readmissions, complications, health care utilization) at 1, 6, 12, and 24 months after discharge. RESULTS: MarketScan identified 116,749 patients who underwent lumbar fusion with ≥24 months of follow-up; 6% had OP. OP patients had a higher incidence of complications (14% vs. 9%); were less likely to be discharged home (77% vs. 86%, P < 0.05); had more new fusions or refusions at 6 months (2.9% vs. 2.1%), 12 months (5% vs. 3.8%), and 24 months (8.5% vs. 7.4%); incurred more outpatient services at 12 months (80 vs. 61) and 24 months (148 vs. 115); and incurred higher overall costs at 12 months ($22,932 vs. $17,017) and 24 months ($48,379 vs. $35,888). Elderly OP patients (>65 years old) who underwent multilevel lumbar fusions had longer hospitalization, had higher complication rates, and incurred lower costs at 6, 12, and 24 months compared with young non-OP patients who underwent single-level lumbar fusion. CONCLUSIONS: Patients of all ages with OP had higher complication rates and required revision surgeries at 6, 12, and 24 months compared with non-OP patients. Elderly OP patients having multilevel lumbar fusions were twice as likely to have complications and lower health care utilization compared with younger non-OP patients who underwent single-level fusion.
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Osteoporosis/complicaciones , Aceptación de la Atención de Salud/estadística & datos numéricos , Enfermedades de la Columna Vertebral/complicaciones , Enfermedades de la Columna Vertebral/cirugía , Fusión Vertebral , Anciano , Bases de Datos Factuales , Femenino , Humanos , Región Lumbosacra/cirugía , Masculino , Persona de Mediana Edad , Osteoporosis/epidemiología , Complicaciones Posoperatorias/epidemiología , Reoperación/estadística & datos numéricos , Enfermedades de la Columna Vertebral/epidemiología , Resultado del TratamientoRESUMEN
A rapid bioassay is presented for determining acute toxicity directly in soil. Modifying the Organisation for Economic Cooperation and Development (OECD) protocol 207, it uses a thin layer of moistened soil laid directly in the bottom of the bioassay jar into which the earthworms are placed and incubated. Examples are presented in comparisons between the soil contact bioassay vs. the filter paper bioassay run on Toxicity Characteristic Leaching Procedure (TCLP) extracts of pesticide contaminated soil and petroleum drilling cuttings. In 2,4-dichlorophenoxyacetic acid (2,4-D) contaminated soil (300mg/Kg), no mortality was found in soil extracts, but 100% mortality was found when exposed directly to soil. Treatment with the Daremend® product in five anaerobic/aerobic cycles slowly reduced the 24 h mortality (0%) but still showed 100% mortality at 48 h. However, severe sub-lethal effects (expulsion of celomic/bloody fluids) were reduced from 50% to 37%, and further treatment may reduce the toxicity to acceptable levels. The petroleum drilling cuttings treated by chemical oxidation (1.3% H2O2, w/w) and bioremediation (simulation of biopiles), showed a similar response, where 0% mortality in soil extracts was found, but 100% mortality with soil contact. Post-treatment with chemical oxidation resulted in a reduction in the soil contact bioassay to 3% and 13% mortality, within the accepted range (≤10%) of the OECD protocol. Observations are presented with respect to moisture control to prevent earthworm desiccation and recommendation for confirmation using the sub-chronic test in the OECD protocol but by testing the contaminated/treated soil itself rather than artificial soil.
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Recurrencia Local de Neoplasia/cirugía , Neoplasias de Tejido Muscular/cirugía , Sarcoma/cirugía , Neoplasias de la Columna Vertebral/cirugía , Vértebras Torácicas/cirugía , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Clasificación del Tumor/métodos , Recurrencia Local de Neoplasia/diagnóstico por imagen , Recurrencia Local de Neoplasia/radioterapia , Neoplasias de Tejido Muscular/diagnóstico por imagen , Neoplasias de Tejido Muscular/radioterapia , Sarcoma/diagnóstico por imagen , Sarcoma/radioterapia , Neoplasias de la Columna Vertebral/diagnóstico por imagen , Neoplasias de la Columna Vertebral/radioterapia , Vértebras Torácicas/diagnóstico por imagenRESUMEN
ResumenLa telangiectasia hemorrágica hereditaria o síndrome de Rendu-Osler-Weber, es un desorden autonómico dominante, debido a mutaciones del gen de la endoglina o del gen de la cinasa análoga al receptor de activina. Dicha enfermedad se caracteriza por la presencia de telangiectasias en piel y mucosas, epistaxis recurrente y espontánea, además de malformaciones arteriovenosas en pulmones, cerebro y sistema gastrointestinal. Se ha reportado la asociación entre esta entidad e infecciones en diferentes sitios por Staphylococcus aureus. Los mecanismos de dicha predisposición incluyen la presencia de fístulas arteriovenosas y disfunción polimorfonuclear. Se reporta el caso de una paciente portadora de la enfermedad que asoció osteomielitis vertebral; requirió tratamiento antibiótico prolongado y cirugía de fusión e instrumentación de la columna vertebral a nivel torácico. Es necesario considerar este tipo de infecciones en pacientes con tal enfermedad, lo cual puede ayudar a la escogencia del tratamiento antibiótico y del manejo del paciente más expedito.
AbstractHereditary Hemorrhagic Telangiectasia or Osler-Weber-Rendu syndrome is a dominant autonomic disorder caused by mutations of the endoglin gene or the kinase gene similar to the activin receptor. This disease is characterized by the presence of telangiectasia on skin and mucous, recurrent and spontaneous epistaxis, as well as arteriovenous malformations in lungs, brain and gastrointestinal system. The association between this disease and infections in several places of the body with Staphylococcus aureushas been reported. The mechanisms of this predisposition include the presence of arteriovenous fistulas and polymorphonuclear dysfunction. A case is reported about a patient carrying the disease associated with vertebral osteomyelitis, who required a prolonged antibiotic treatment and instrumentation of the vertebral column at thoracic level. It is necessary to consider this type of infections in patients with this disease, which may help when choosing the antibiotic treatment and a more expeditious patient management.
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Humanos , Discitis , Staphylococcus aureus , Telangiectasia Hemorrágica Hereditaria/complicacionesRESUMEN
Chrysobacterium meningosepticum es una bacteria ambiental que sobrevive en ambientes nosocomiales diversos y es capaz de producir infecciones en pacientes debilitados, colonizando inicialmente el tracto respiratorio. Esta bacteria muestra resistencia a muchos antimicrobianos, por lo que se vuelve difícil tratar una infección causada por este germen. Se describe la evolución de un cuadro infeccioso presentado por una paciente de 66 años, con insuficiencia cardíaca, hepatopatía e inmunocomprometida por tratamiento con prednisona para controlar la artritis reumatoidea que padecía. Cinco días antes del internamiento, la paciente presentó un cuadro de disnea progresiva y malestar general. Al momento del ingreso al hospital se mostraba afebril, hipotensa, con leucocitosis absoluta con desviación izquierda y alteración de función renal y hepática. Durante el segundo día fue necesario suministrar oxígeno suplementario y tratamiento para la insuficiencia cardíaca. Al tercer día de internamiento presentó fiebre, mayor disnea, delirio y taquicardia y se inició el tratamiento empírico con cefotaxime y amikacina. Los cultivos de orina y esputo tomados al momento de su ingreso fueron negativos por bacterias. Al cuarto día la paciente continuaba febril y con mayor deterioro del cuadro respiratorio y un grado de delirio importante. Se cambió el tratamiento a cefotaxime, ampicilina y vancomicina y se realizó punción lumbar. El líquido cefalorraquídeo presentó 31000 leucocitos/uL con 92 por ciento de polimofonucleares, proteínas elevadas y en la tinción de Gram del sedimento se encontró gran cantidad de bacilos Gram negativos. De un hemocultivo tomado previamente se aisló un bacilo Gram negativo. Al quinto dia, la paciente presentó choque séptico que complicó su estado general y provocó su fallecimiento. Los cultivos de sangre y de líquido cefalorraquídeo revelaron la presencia de C. meningosepticum. El caso se ajusta a las descripciones hechas en la literatura para C. menin...
Chrysobacterium meningosepticum is an environmental bacterium that can survive in different nosocomial environments and is able to produce infections in debilitated patients by initial colonization of the respiratory tract. This bacterium exhibits resistance to many antimicrobial agents what makes very difficult its eradication from an infectious process. Clinical evolution of an infectious disease caused by C. meningosepticum in a 66 years old immunocompromised patient is described. Five days before being hospitalized, the patient exhibited progressive dyspnea and malaise. When the patient was admitted into the hospital she was afebrile and hypotensive; blood tests showed leukocytosis with juvenile forms (left shift) and kidney and liver functions altered. Supplementary oxygen and treatment for cardiac insufficiency were provided during the second day. At the third day she exhibited fever, dyspnea and tachycardia. Empirical antimicrobial treatment with cefotaxime and amikacin was started. Bacteriological cultures of urine and sputum taken at the time the patient was admitted to the hospital were negative. During fourth day the patient continued with fever, the respiratory problem got worse and delirium was present. Antimicrobial treatment was changed to cefotaxime, ampicillin and vancomycin and a lumbar puncture was performed. The cerebrospinal fl uid (CSF) showed 31000 leukocytes/µL (92% polymorphonuclear leukocytes), elevated protein concentration and a high amount of Gram-negative bacilli in the sediment. A Gram-negative bacillus was also isolated from a blood culture previously taken. The fifth day of hospitalization, the patient entered in septic shock, the general condition got worse and she died. CSF and blood cultures were positive for C. meningosepticum...