Abstract Objective To evaluate in vitro the viability of mesenchymal stem cells derived from adipose tissue (AD-MSCs) in different commercial solutions of hyaluronic acid (HA) before and after being sowed in collagen I/III membrane. Methods In the first stage, the interaction between AD-MSCs was analyzed with seven different commercial products of HA, phosphate buffered saline (PBS), and bovine fetal serum (BFS), performed by counting living and dead cells after 24, 48 and 72 hours. Five products with a higher number of living cells were selected and the interaction between HA with AD-MSCs and type I/III collagen membrane was evaluated by counting living and dead cells in the same time interval (24, 48 and 72 hours). Results In both situations analyzed (HA + AD-MSCs and HA + AD-MSCs + membrane), BFS presented the highest percentage of living cells after 24, 48 and 72 hours, a result higher than that of HA. Conclusion The association of HA with AD-MSCs, with or without membrane, showed no superiority in cell viability when compared with BFS.

Resumo Objetivo Avaliar in vitro a viabilidade das células-tronco mesenquimais derivadas do tecido adiposo (AD-CTMs) em diferentes soluções comerciais de ácido hialurônico (AH) antes e após serem semeadas em membrana de colágeno I/III. Métodos Na primeira etapa, analisou-se a interação entre AD-CTMs com sete diferentes produtos comerciais de AH, salina tamponada com fosfato (PBS, na sigla em inglês) e soro fetal bovino (SFB), realizada pela contagem das células vivas e mortas após 24, 48 e 72 horas. Foram selecionados cinco produtos com maior número de células vivas e avaliou-se a interação entre o AH com AD-CTMs e a membrana de colágeno tipo I/III pela contagem de células vivas e mortas no mesmo intervalo de tempo (24, 48 e 72 horas). Resultados Em ambas as situações analisadas (AH + AD-CTM e AH + AD-CTM + membrana), o SFB apresentou a maior porcentagem de células vivas após 24, 48 e 72 horas, resultado superior ao do AH. Conclusão A associação do AH com as AD-CTMs, com ou sem a membrana, não demonstrou superioridade na viabilidade celular quando comparado com SFB.

ABSTRACT Objective To analyze pain, functional capacity, quality of life, anxiety and depression outcomes in patients undergoing lumbar spine surgery following use of the Second Opinion Program, and to present disagreements regarding diagnoses and therapeutic indications between the first and second opinions. Methods A prospective, observational cohort study with 100 patients enrolled in the Second Opinion Program who underwent lumbar spine surgery. Questionnaires addressing pain intensity, level of disability, quality of life, anxiety and depression were applied prior to and within 1, 3, 6 and 12 months of surgery. Descriptive and comparative statistical analyses were performed. The following clinical outcomes were analyzed: pain intensity, level of disability, quality of life, anxiety, and depression. Results In this sample, 88% and 12% out of 100 patients were submitted to lumbar decompression and arthrodesis, respectively. Patients reported improvements in function, pain intensity, and quality of life factors following surgery and were able to attain the minimal clinically important difference relative to the preoperative period. Agreement between the first and second opinions was observed in 44% of diagnoses, and in 27% of therapeutic indications. Conclusion Patients had favorable postoperative outcomes regarding pain, disability, and quality of life. These findings and the high rates of diagnostic and therapeutic indication disagreements corroborate the need of a second opinion in cases of spine disease with surgical indications.

ABSTRACT Objective Phase 1 clinical trial to determine feasibility, safety, and efficacy of a new advanced cell therapy product for treatment of knee articular cartilage injuries. Methods Three participants with knee focal chondral lesions were included, with no signs of osteoarthritis. Chondrocytes were obtained through knee arthroscopy, cultured in collagen membrane for 3 weeks at the laboratory, subjected to tests to release the cell therapy product, and implanted. All patients underwent a specific 3-month rehabilitation protocol, followed by assessments using functional and imaging scales. The main outcome was the incidence of severe adverse events. Results Three participants were included and completed the 2-year follow-up. There was one severe adverse event, venous thrombosis of distal leg veins, which was no associated with therapy, was treated and left no sequelae. The clinical and radiological scales showed improvement in the three cases. Conclusion The preliminary results, obtained with the described methodology, allow concluding that this product of advanced cell therapy is safe and feasible. ReBEC platform registration number: RBR-6fgy76

ABSTRACT To describe a case of autologous chondrocyte implantation after cell culture contamination by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy in a patient with focal chondral lesion. A 45-year-old male patient, complaining of chronic pain on the knee and no history of trauma. He had a chondral lesion in the trochlear region of the femur and clinical tests compatible with pain in the anterior compartment of the knee. Conservative treatment failed to alleviate symptoms. Surgical treatment was indicated, but due to the size of the lesion, membrane-assisted autologous chondrocyte implantation was the technique of choice. Cartilage biopsies were collected from the intercondylar region of the distal femur. After isolation, chondrocytes were expanded ex vivo in a trained laboratory, for three weeks, and seeded onto a commercially available collagen membrane prior to implantation in the knee. Two days before surgery, a cell culture sample tested positive for Mycoplasma pneumoniae. The source of contamination was found to be autologous blood serum, extracted from the patient´s peripheral vein, and used to supplement the cell culture medium. After treating the patient with antibiotics, all procedures were repeated and the new final cell product, free from contaminants, was successfully implanted. We discuss the strategies available to deal with this situation, and describe the results of this particular case, which led to modifications in the autologous chondrocyte implant protocol.

RESUMO No Brasil, não há registros da prevalência do tipo de fixação da artroplastia total de quadril (ATQ). Objetivo: (i) Descrever perfil demográfico de pacientes submetidos à ATQ no Sistema Único de Saúde de São Paulo durante os últimos doze anos; e (ii) comparar as técnicas de fixação de ATQ quanto aos custos, tempo de internação (TI) e taxa de óbito. Métodos: Estudo ecológico, com dados disponíveis na TabNet do DATASUS. Dados públicos de procedimentos de ATQ eletivos realizados em São Paulo de 2008 a 2019 foram extraídos. Foram analisados: sexo, idade, região municipal, método de fixação em ATQ, número de cirurgias, custo, tempo de internação e óbitos. Resultados: Foram analisadas 7.673 ATQs, sendo 6.220 (81%) não-cimentada/híbridas e 1.453 (19%) cimentadas. A fixação não-cimentada/híbrida teve custo maior em US$ 495,27 do que a cimentada (p < 0,001). Entretanto, TI foi 0,87 dia mais longo na fixação cimentada. Não houve diferença significativa nas taxas de óbito entre os métodos de fixação. Conclusão: A fixação não-cimentada/híbrida na ATQ é prevalente em São Paulo, e apresentou maior custo total, porém menor tempo de internação do que a fixação cimentada. Não houve diferença entre o método de fixação em ATQ e a taxa de óbito. Nível de Evidência IV, Série de Casos.

ABSTRACT Brazil lacks registries on the prevalence of primary total hip arthroplasty (THA) fixation methods. Objective: (i) to describe the demographic profile of patients who underwent THA in the public health system of the municipality of São Paulo during the last 12 years and (ii) to compare fixation methods regarding costs, hospital stay length, and death rates. Methods: This is an ecological study conducted with data available on TabNet, a platform belonging to DATASUS. Public data (from the government health system) on THA procedures performed in São Paulo from 2008 to 2019 were extracted. Gender, age, city region, THA fixation method, number of surgeries, costs, hospital stay length, and death rates were analyzed. Results: We analyzed 7,673 THA, of which 6220 (81%) were performed via cementless/hybrid fixation and 1453 (19%), via the cemented technique. Cementless/hybrid fixation had a higher cost (US$ 495.27) than the cemented one (p < 0.001). Nevertheless, hospital stay length was 0.87 days longer for cemented fixation than the cementless/hybrid one. We found no significant difference in death rates between THA fixation methods. Conclusion: THA cementless/hybrid fixation is prevalent in the municipality of São Paulo, which had higher total costs and shorter hospitalizations than cemented fixation. We found no difference between THA fixation methods and death rates. Level of Evidence IV, Case Series.

Resumo: Objetivo: Relacionar a taxa de fusão radiográfica e os resultados cirúrgicos nos pacientes submetidos a artrodese posterolateral com instrumentação da coluna lombar para tratamento de afecções degenerativas. Método: Estudo observacional retrospectivo descritivo, tipo série de casos, com base em prontuários médicos e exames de imagem de 76 pacientes maiores de 18 anos (39 a 88 anos), submetidos a artrodese lombar posterolateral. Dados relacionados a presença de comorbidades foram compilados e os desfechos clínicos mensurados por meio de questionários específicos coletados no pré-cirúrgico e após um ano pós-cirúrgico. A qualidade da fusão, conforme descrita por Christensen, foi avaliada a partir de imagens radiográficas por dois examinadores. Os questionários de EVA, EQ-5D e Roland Morris foram utilizados no pré-cirúrgico e um ano pós-cirúrgico para avaliar dor, qualidade de vida e função, respectivamente. Resultado: Observou se melhora na dor, função e qualidade de vida após um ano pós-cirúrgico. A dor, mensurada pelo EVA teve uma redução de 7,92 para 3,16 (p-valor <0,001), a função avaliada pelo escore Roland Morris, também apresentou redução de 14,90 para 7,06 (p-valor <0,001). Culminando com a melhora na qualidade de vida, mensurada pelo EQ-5D, onde observou-se um aumento mediano escore de 0,5672 para 0,7002 (p-valor = 0,002). Conclusão: A ausência de fusão radiográfica não tem correlação direta com piores resultados nos desfechos clínicos em um ano de pós-cirúrgico. Maioritariamente, os pacientes apresentaram melhora clínica sem diferença estatística em relação aos casos em que foi obtido fusão óssea. Nível de evidência IV; Observacional retrospectivo.

ABSTRACT Objective: To relate the radiographic fusion rate and the surgical results in patients undergoing posterolateral arthrodesis with instrumentation of the lumbar spine for the treatment of degenerative disorders. Method: A descriptive, retrospective, case series, observational study, based on medical records and imaging studies of 76 patients over 18 years of age (39 to 88 years) who underwent posterolateral lumbar arthrodesis. Data related to the presence of comorbidities were compiled and clinical outcomes were measured using specific questionnaires collected pre-surgical and 1 year after surgery. Fusion quality, as described by Christensen, was assessed from radiographic images by two examiners. The VAS, EQ-5D and Roland Morris questionnaires were used preoperatively and 1 year after surgery to assess pain, quality of life and function, respectively. Result: It was observed improvement in pain, function and quality of life after 1 year post-surgical. Pain, measured by VAS, had a reduction from 7.92 to 3.16 (p-value <0.001), the function evaluated by the Roland Morris score, also showed a reduction from 14.90 to 7.06 (p-value <0.001) . Culminating with the improvement in quality of life, measured by the EQ-5D, where there was a median increase in the score from 0.5672 to 0.7002 (p-value = 0.002). Conclusion: The absence of radiographic fusion has no direct correlation with worse results in clinical outcomes at 01 year after surgery. Most patients showed clinical improvement with no statistical difference in relation to cases in which bone fusion was obtained. Level of evidence IV; retrospective observation.

Resumen: Objetivo: Relacionar ei índice de fusión radiográfica y los resultados quirúrgicos en pacientes sometidos a artrodesis posterolateral con instrumentación de columna lumbar para el tratamiento de trastornos degenerativos. Método: Estudio descriptivo, retrospectivo, serie de casos, observacional, basado en historias clínicas y estudios de imagen de 76 pacientes may ores de 18 anos (39 a 88 anos) a quienes se les realizó artrodesis lumbar posterolateral. Se recopilaron datos relacionados con la presencia de comorbilidades y se midieron los resultados clínicos mediante cuestionarios específicos recogidos antes de la cirugía y al año de la cirugía. La calidad de la fusión, según lo descrito por Christensen, fue evaluada a partir de imágenes radiográficas por dos examinadores. Los cuestionarios VAS, EQ-5D y Roland Morris se utilizaron en el preoperatorio y 1 año después de la cirugía para evaluar el dolor, la calidad de vida y la función, respectivamente. Resultado: Se observó mejoría en el dolor, función y calidad de vida después de 1 año posquirúrgico. El dolor, medido por EVA, tuvo una reducción de 7,92 a 3,16 (p-valor <0,001), la función evaluada por el puntaje de Roland Morris, también mostró una reducción de 14,90 a 7,06 (p-valor <0,001). Culminando con la mejora en la calidad de vida, medida por el EQ-5D, donde hubo un aumento mediano en el puntaje de 0,5672 a 0,7002 (p-valor = 0,002). Conclusión: La ausencia de fusión radiográfica no tiene correlación directa con peores resultados en los resultados clínicos al 01 año de la cirugía. La mayoría de los pacientes presentaron mejoría clínica sin diferencia estadística en relación a los casos en los que se obtuvo fusión ósea. Nivel de evidencia IV; observación retrospectiva.

Resumo Objetivo Comparar a dor, a função, a qualidade de vida e os eventos adversos da descompressão lombar e da fusão espinhal em pacientes com patologias degenerativas da coluna vertebral que participaram de um programa de segunda opinião para cirurgias de coluna com acompanhamento de 36 meses. Métodos Os dados desta coorte retrospectiva foram obtidos de um sistema de saúde privado entre junho de 2011 e janeiro de 2014. A amostra do estudo foi composta por 71 pacientes encaminhados para cirurgia de coluna lombar. Os desfechos para comparações entre a descompressão lombar e a fusão espinhal foram qualidade de vida (avaliada pelo questionário EuroQoL 5D), dor (medida pela Escala Numérica de Classificação de Dor) e função (avaliada pelo Questionário de Incapacidade de Roland Morris) no início do estudo e aos 12 e 36 meses de acompanhamento pós-cirúrgico. As definições de recuperação foram estabelecidas pela diferença mínima clinicamente importante (DMCI). As diferenças basais entre os grupos foram analisadas por teste t não pareado, e as diferenças nas pontuações dos instrumentos entre os momentos, por modelos mistos generalizados. Os resultados foram apresentados como valores médios ajustados pelos modelos e intervalos de confiança de 95%. Resultados No total, 22 pacientes foram submetidos à artrodese, e 49 pacientes, à descompressão lombar. Quanto às comparações de achados antes e depois das intervenções cirúrgicas, a DMCI foi alcançada em todos os desfechos de qualidade de vida, dor e função nos dois pontos de acompanhamento em relação aos escores basais Em relação às complicações, apenas a descompressão lombar apresentou 4% (n = 3) de taxa cirúrgica de recidiva da hérnia de disco lombar. Conclusão Pacientes com patologias espinhais degenerativas apresentam melhoras nos desfechos de dor, função e qualidade de vida em longo prazo que são clinicamente significativas e independentes da intervenção cirúrgica.

Abstract Objective To compare pain, function, quality of life and adverse events of lumbar decompression and spinal fusion in patients with degenerative spinal pathologies who participated in a second opinion program for spinal surgeries with a 36-month followup. Methods The data for this retrospective cohort were withdrawn from a private healthcare system between June 2011 and January 2014. The study sample consisted of 71 patients with a lumbar spine surgical referral. The outcomes for the comparisons between lumbar decompression and spinal fusion were quality of life (evaluated through the EuroQoL 5D), pain (measured by the Numerical Rating Scale) and function (assessed through the Roland Morris Disability Questionnaire) measured at baseline, and at 12 and 36 months after the surgical procedures. The definitions of recovery were established by the minimal clinically important difference (MCID). The baseline differences between the groups were analyzed by non-paired t-test, and the differences in instrument scores between time points, by generalized mixed models. The results were presented as mean values adjusted by the models and 95% confidence intervals. Results Concerning the surgical techniques, 22 patients were submitted to spinal fusion and 49 patients, to lumbar decompression. As for the comparisons of the findings before and after the surgical interventions, the MCID was achieved in all outcomes regarding quality of life, pain and function at both time points when compared to baseline scores Moreover, concerning the complication rates, only lumbar decompression presented a surgical rate of 4% (n = 3) for recurrence of lumbar disc hernia. Conclusion Patients with degenerative spinal pathologies present improvements in long-term outcomes of pain, function and quality of life which are clinically significant, no matter the surgical intervention.

RESUMO Objetivo: Avaliar fatores de crescimento e citocinas em amostras de plasma rico em plaquetas obtidas por três diferentes métodos de centrifugação. Métodos: Foi coletado sangue periférico de seis indivíduos, sem doença hematológica, com idades entre 18 e 68 anos, para obtenção de plasma rico em plaquetas, utilizando o método aberto e sistemas comerciais das empresas Medtronic e Biomet. Os produtos obtidos com os diferentes tipos de centrifugação foram submetidos às análises laboratoriais, incluindo citocinas próinflamatórias e quimiocinas, por meio de ensaios de citometria de fluxo, concentração do fator de crescimento fibroblástico-2 (FGF-2) e fator de crescimento transformador-beta1 (TGF-β1). Resultados: As diferentes centrifugações geraram perfis sistematicamente diferentes referentes ao número de plaquetas e de leucócitos. O sistema da Medtronic originou produto com a maior concentração de plaquetas, e o método aberto com a menor concentração de plaquetas. Os resultados da análise de citocinas demonstraram que os diferentes tipos de centrifugação originaram produtos com elevadas concentrações de interleucina 8 e interleucina 1β. O sistema aberto resultou em produto com elevados níveis de interleucina 6. As demais citocinas e quimiocinas mensuradas foram similares entre os sistemas. O produto obtido com o método aberto apresentou níveis superiores de TGF-β1 em relação aos demais sistemas e reduzidos níveis de FGF-2. Conclusão: Os elementos figurados, fatores de crescimento e citocinas, em amostras de plasma rico em plaquetas, variaram conforme a técnica de centrifugação utilizada.

ABSTRACT Objective: To evaluate growth factors and cytokines in samples of platelet-rich plasma obtained by three different centrifugation methods. Methods: Peripheral blood of six individuals with no hematological diseases, aged 18 to 68 years, was drawn to obtain platelet-rich plasma, using the open method and commercial columns by Medtronic and Biomet. The products obtained with the different types of centrifugation were submitted to laboratory analysis, including pro-inflammatory cytokines and chemokines by flow cytometry assays, the concentration of fibroblast growth factors-2 (FGF-2) and transforming growth factor-beta1 (TGF-β1). Results: The diverse separation methods generated systematically different profiles regarding number of platelets and leukocytes. The Medtronic system yielded a product with the highest concentration of platelets, and the open method, with the lowest concentration of platelets. The results of cytokine analysis showed that the different types of centrifugation yielded products with high concentrations of interleukin 8, interleukin 1β. The open system resulted in a product with high levels of interleukin 6. Other cytokines and chemokines measured were similar between systems. The product obtained with the open method showed higher levels of TGF-β1 in relation to other systems and low FGF-2 levels. Conclusion: The formed elements, growth factors and cytokines in samples of platelet-rich plasma varied according to the centrifugation technique used.

RESUMO Objetivo: Correlacionar dados epidemiológicos, hábitos de vida e fatores psicossociais como preditivos para manifestação clínica de dorsolombalgia em pacientes atendidos no setor de urgências ortopédicas de hospital terciário brasileiro, além de avaliar o interesse em participar de programa hipotético para reabilitação física. Métodos: Trata-se de estudo observacional do tipo transversal. Foram avaliados 210 pacientes provenientes do pronto atendimento de um hospital terciário, com queixa predominante de dor nas costas. Foram utilizados: questionários epidemiológicos do tipo múltipla escolha desenvolvidos para o presente estudo; questionário Oswestry para incapacidade física; e escala Hospital Anxiety and Depression Scale (HAD). As análises dos dados foram realizadas por meio do programa SAS - Statistical Analysis System (SAS Institute, 2001). Os cálculos foram realizados com as funções Proc MEANS e Proc Freq do SAS. Resultados: A média de idade foi de 39,1 anos e não houve predominância entre os gêneros. A atividade laborativa mais frequente foi a administrativa (65,2% dos casos). Observou-se índice de massa corporal médio de 26,0, que indicou sobrepeso. A maioria (83,3%) dos pacientes apresentou baixa incapacidade física (Oswestry de 0 – 40%). O número de visitas nos 6 meses anteriores (p=0,04) e os escores de ansiedade e depressão (p=0,05), isoladamente, tiveram correlação com a incapacidade física. A maioria dos pacientes (77%) aceitaria participar de programa hipotético de reabilitação física para prevenção de dores nas costas. Conclusão: Os pacientes com queixa de dorsolombalgia foram, predominantemente, adultos jovens, sedentários ou hipoativos, com sobrepeso e com queixas recorrentes dos sintomas. A maioria dos participantes apresentou baixa incapacidade física e aceitaria participar de programa hipotético de reabilitação física para a prevenção de dores nas costas.

ABSTRACT Objective: To correlate epidemiological data, lifestyle, and psychosocial factors as predictors for clinical manifestation of back pain in patients treated at the orthopedic emergency unit of a Brazilian tertiary care hospital, and to evaluate their interest in participating in a hypothetical program for physical rehabilitation. Methods: This is an observational cross-sectional study. We evaluated 210 patients from the emergency department of a tertiary hospital with a major complaint of back pain. We used: epidemiological multiple-choice questionnaires developed for this study; Oswestry questionnaire for physical disability; Hospital Anxiety and Depression Scale (HAD) scale. Data analyses were performed using SAS - Statistical Analysis System (SAS Institute, 2001). Measurements were performed with the SAS functions Proc MEANS and Proc Freq. Results: The mean age was 39.1 years and there was no predominance between genders. The usual work activity was administrative (65.2% of cases). The mean body mass index was 26.0, indicating overweight. The majority (83.3%) of patients had low physical disability (Oswestry 0 – 40%). The number of medical visits in the previous 6 months (p=0.04) and the scores of anxiety and depression (p=0.05), independently, were correlated with physical disability. Most patients (77%) would agree to participate in a hypothetical program of physical rehabilitation for prevention of back pain. Conclusion: Patients with back pain complaints were predominantly young adults, sedentary or hypoactive, overweight, and with recurrent complaints of symptoms. Most participants had low levels of physical disability and would accept participation in a hypothetical physical rehabilitation program for the prevention of back pain.