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5. Hypokalemia in Patients with COVID-19

Author

Alfano, G., Ferrari, A., Fontana, F., Perrone, R., Mori, G., Ascione, E., Magistroni, R., Venturi, G., Pederzoli, S., Margiotta, G., Romeo, M., Piccinini, F., Franceschi, G., Volpi, S., Faltoni, M., Ciusa, G., Bacca, E., Tutone, M., Raimondi, A., Menozzi, M., Franceschini, E., Cuomo, G., Orlando, G., Santoro, A., Di Gaetano, M., Puzzolante, C., Carli, F., Bedini, A., Milic, J., Meschiari, M., Mussini, C., Cappelli, G., Guaraldi, G., Borghi, V., Burastero, G., Corradi, L., Dolci, G., Fantini, R., Iadisernia, V., Larne, D., Pellegrino, F., Rogati, C., Tonelli, R., Yaacoub, D., Alfan, S., Marco, B., Pulizzi, R., Leonelli, M., Facchini, F., Damiano, F., Girardis, M., Andreotti, A., Biagioni, E., Bondi, F., Busani, S., Chierego, G., Scotti, M., Cossarizza, L. S. A., Bellinazzi, C., Borella, R., De Biasi, S., De Gaetano, A., Fidanza, L., Gibellini, L., Iannone, A., Tartaro, D. L., Mattioli, M., Nasi, M., Paolini, A., and Pinti, M.

Subjects
Male, Pediatrics, Physiology, medicine.medical_treatment, 030232 urology & nephrology, Urine, 030204 cardiovascular system & hematology, Electrolytes, 0302 clinical medicine, Risk Factors, 80 and over, Prevalence, Medicine, Magnesium, Hospital Mortality, Diuretics, COVID, Aged, 80 and over, Urinary potassium loss, Middle Aged, Hypokalemia, Nephrology, Cohort, Original Article, Female, SOFA score, medicine.symptom, Coronavirus, Potassium, Aged, COVID-19, Humans, Retrospective Studies, SARS-CoV-2, Electrolyte Disorder, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Anorexia, 03 medical and health sciences, Physiology (medical), Internal medicine, Hyperventilation, In patient, business.industry, Retrospective cohort study, Odds ratio, Diuretic, business
Abstract

Patients with COVID-19 may experience multiple conditions (e.g., fever, hyperventilation, anorexia, gastroenteritis, acid-base disorder) that may cause electrolyte imbalances. Hypokalemia is a concerning electrolyte disorder that may increase the susceptibility to various kinds of arrhythmia. This study aimed to estimate prevalence, risk factors and outcome of hypokalemia in a cohort of non-critically ill patients. A retrospective analysis was conducted on 290 hospitalized patients with confirmed COVID-19 infection at the tertiary teaching hospital of Modena, Italy.Hypokalemia (Hypokalemia is a frequent disorder in COVID-19 patients and urinary potassium loss may be the main cause of hypokalemia. The disorder was mild in the majority of the patients and was unrelated to poor outcomes. Nevertheless, hypokalemic patients required potassium supplements to dampen the risk of arrhythmias.

Published
2021
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6. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial

Author

Salvarani, C, Massari, M, Costantini, M, Franco Merlo, D, Lucia Mariani, G, Viale, P, Nava, S, Guaraldi, G, Dolci, G, Boni, L, Savoldi, L, Bruzzi, P, Turrà, C, Catanoso, M, Maria Marata, A, Barbieri, C, Valcavi, A, Franzoni, F, Cavuto, S, Mazzi, G, Corsini, R, Trapani, F, Bartoloni, A, Barisione, E, Jole Burastero, G, Pan, A, Inojosa, W, Scala, R, Burattini, C, Luppi, F, Codeluppi, M, Eldin Tarek, K, Cenderello, G, Salio, M, Foti, G, Dongilli, R, Bajocchi, G, Alberto Negri, E, Ciusa, G, Fornaro, G, Bassi, I, Zammarchi, L, Aloè, T, Facciolongo, N, Salvarani, Carlo, Massari, Marco, Costantini, Massimo, Franco Merlo, Domenico, Lucia Mariani, Gabriella, Viale, Pierluigi, Nava, Stefano, Guaraldi, Giovanni, Dolci, Giovanni, Boni, Luca, Savoldi, Luisa, Bruzzi, Paolo, Turrà, Caterina, Catanoso, Mariagrazia, Maria Marata, Anna, Barbieri, Chiara, Valcavi, Annamaria, Franzoni, Francesca, Cavuto, Silvio, Mazzi, Giorgio, Corsini, Romina, Trapani, Fabio, Bartoloni, Alessandro, Barisione, Emanuela, Jole Burastero, Giulia, Pan, Angelo, Inojosa, Walter, Scala, Raffaele, Burattini, Cecilia, Luppi, Fabrizio, Codeluppi, Mauro, Eldin Tarek, Kamal, Cenderello, Giovanni, Salio, Mario, Foti, Giuseppe, Dongilli, Roberto, Bajocchi, Gianluigi, Alberto Negri, Emanuele, Ciusa, Giacomo, Fornaro, Giacomo, Bassi, Ilaria, Zammarchi, Lorenzo, Aloè, Teresita, Facciolongo, Nicola, Salvarani, C, Massari, M, Costantini, M, Franco Merlo, D, Lucia Mariani, G, Viale, P, Nava, S, Guaraldi, G, Dolci, G, Boni, L, Savoldi, L, Bruzzi, P, Turrà, C, Catanoso, M, Maria Marata, A, Barbieri, C, Valcavi, A, Franzoni, F, Cavuto, S, Mazzi, G, Corsini, R, Trapani, F, Bartoloni, A, Barisione, E, Jole Burastero, G, Pan, A, Inojosa, W, Scala, R, Burattini, C, Luppi, F, Codeluppi, M, Eldin Tarek, K, Cenderello, G, Salio, M, Foti, G, Dongilli, R, Bajocchi, G, Alberto Negri, E, Ciusa, G, Fornaro, G, Bassi, I, Zammarchi, L, Aloè, T, Facciolongo, N, Salvarani, Carlo, Massari, Marco, Costantini, Massimo, Franco Merlo, Domenico, Lucia Mariani, Gabriella, Viale, Pierluigi, Nava, Stefano, Guaraldi, Giovanni, Dolci, Giovanni, Boni, Luca, Savoldi, Luisa, Bruzzi, Paolo, Turrà, Caterina, Catanoso, Mariagrazia, Maria Marata, Anna, Barbieri, Chiara, Valcavi, Annamaria, Franzoni, Francesca, Cavuto, Silvio, Mazzi, Giorgio, Corsini, Romina, Trapani, Fabio, Bartoloni, Alessandro, Barisione, Emanuela, Jole Burastero, Giulia, Pan, Angelo, Inojosa, Walter, Scala, Raffaele, Burattini, Cecilia, Luppi, Fabrizio, Codeluppi, Mauro, Eldin Tarek, Kamal, Cenderello, Giovanni, Salio, Mario, Foti, Giuseppe, Dongilli, Roberto, Bajocchi, Gianluigi, Alberto Negri, Emanuele, Ciusa, Giacomo, Fornaro, Giacomo, Bassi, Ilaria, Zammarchi, Lorenzo, Aloè, Teresita, and Facciolongo, Nicola

Abstract

Rationale Pulse glucocorticoid therapy is used in hyperinflammation related to coronavirus disease 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia. Methods In this multicentre, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with COVID-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for three consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need for supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival. Results Overall, 112 (75.4%) out of 151 patients in the pulse methylprednisolone arm and 111 (75.2%) of 150 in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups (15 days, 95% CI 13.0–17.0 days and 16 days, 95% CI 13.8–18.2 days, respectively; hazard ratio (HR) 0.92, 95% CI 0.71–1.20; p=0.528). No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to intensive care unit with orotracheal intubation or death (20.0% versus 16.1%; HR 1.26, 95% CI 0.74–2.16; p=0.176) or overall mortality (10.0% versus 12.2%; HR 0.83, 95% CI 0.42–1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups. Conclusions Methylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.

Published
2022

10. Missed opportunities to prevent mother-to-child transmission of HIV in Italy

Author

Di Biagio, A., Taramasso, L., Gustinetti, G., Burastero, G., Giacomet, V., La Rovere, D., Genovese, O., Giaquinto, C., Rampon, O., Carloni, I., Hyppolite, Tk., Palandri, L., Bernardi, S., Bruzzese, E., Badolato, R., Gabiano, C., Chiappini, E, De Martino, M, Galli, L., Osimani, P., Larovere, D., Ruggeri, M., Pession, A., Faldella, G., Capra, F., Pulcini, S., Zattoni, V., Dotta, L., Aliffi, A., Anastasio, E., Fiumana, E., Chiappini, E., Gervaso, P., Montagnani, C., De Martino, M., Viscoli, C., Erba, P., Zuccotti, G., Benincaso, A., Salvini, F., Lipreri, R., Esposito, S., Plebani, A., Tagliabue, C., Giubbarelli, F., Nicastro, E., Lo Vecchio, A., Buffolano, W., Agnese, M., Romano, A., Marcello, S., Pennazzato, M., Consolini, R., Dodi, I., Zanaboni, D., Palma, P., Pontrelli, G., Tchidjou, H., Mazza, A., Tovo, Pa., Silvestro, E., Virano, S., Portelli, V., Pellegatta, A., Di Biagio, A., Taramasso, L., Gustinetti, G., Burastero, G., Giacomet, V., La Rovere, D., Genovese, O., Giaquinto, C., Rampon, O., Carloni, I., Hyppolite, T. K., Palandri, L., Bernardi, S., Bruzzese, E., Badolato, R., Gabiano, C., Chiappini, E., De Martino, M., Galli, L., Osimani, P., Larovere, D., Ruggeri, M., Pession, A., Faldella, G., Capra, F., Pulcini, S., Zattoni, V., Dotta, L., Aliffi, A., Anastasio, E., Fiumana, E., Gervaso, P., Montagnani, C., Viscoli, C., Erba, P., Zuccotti, G., Benincaso, A., Salvini, F., Lipreri, R., Esposito, S., Plebani, A., Tagliabue, C., Giubbarelli, F., Nicastro, E., Lo Vecchio, A., Buffolano, W., Agnese, M., Romano, A., Marcello, S., Pennazzato, M., Consolini, R., Dodi, I., Zanaboni, D., Palma, P., Pontrelli, G., Tchidjou, H., Mazza, A., Tovo, P. A., Silvestro, E., Virano, S., Portelli, V., and Pellegatta, A.

Subjects
Male, 0301 basic medicine, Pediatrics, newborns, medicine.medical_treatment, children, HIV, missed opportunities, mothers, pregnancy, Human immunodeficiency virus (HIV), HIV Infections, medicine.disease_cause, Health Services Accessibility, Health Policy, Infectious Diseases, Pharmacology (medical), 0302 clinical medicine, newborn, Childbirth, Registries, 030212 general & internal medicine, Pregnancy Complications, Infectious, Transmission (medicine), mother, virus diseases, Settore MED/38, children, HIV, missed opportunities, mothers, newborns, pregnancy, Italy, Female, medicine.medical_specialty, Mother to child transmission, Anti-HIV Agents, Prenatal care, Risk Assessment, 03 medical and health sciences, medicine, Humans, Caesarean section, Peripartum Period, Pregnancy, Cesarean Section, business.industry, Infant, Newborn, Infant, medicine.disease, 030112 virology, Infectious Disease Transmission, Vertical, missed opportunitie, business
Abstract

OBJECTIVES: Vertical transmission of HIV can be effectively controlled through antenatal screening, antiretroviral treatment and the services provided during and after childbirth for mother and newborn. In Italy, the National Health Service guarantees universal access to prenatal care for all women, including women with HIV infection. Despite this, children are diagnosed with HIV infection every year. The aim of the study was to identify missed opportunities for prevention of mother-to-child transmission of HIV. METHODS: The Italian Register for HIV Infection in Children, which was started in 1985 and involves 106 hospitals throughout the country, collects data on all new cases of HIV infection in children. For this analysis, we reviewed the database for the period 2005 to 2015. RESULTS: We found 79 HIV-1-infected children newly diagnosed after birth in Italy. Thirty-two of the mothers were Italian. During the pregnancy, only 15 of 19 women with a known HIV diagnosis were treated with antiretroviral treatment, while, of 34 women who had received an HIV diagnosis before labour began, only 23 delivered by caesarean section and 17 received intrapartum prophylaxis. In 25 mothers, HIV infection was diagnosed during pregnancy or in the peripartum period. Thirty-one newborns received antiretroviral prophylaxis and 39 received infant formula. CONCLUSIONS: We found an unacceptable number of missed opportunities to prevent mother-to-child transmission (MCTC). Eliminating HIV MTCT is a universal World Health Organization goal. Elucidating organization failures in Italy over the past decade should help to improve early diagnosis and to reach the zero transmission target in newborns.

Published
2019

15. Missed opportunities to prevent mother‐to‐child transmission of HIV in Italy.

Author

Di Biagio, A, Taramasso, L, Gustinetti, G, Burastero, G, Giacomet, V, La Rovere, D, Genovese, O, Giaquinto, C, Rampon, O, Carloni, I, Hyppolite, TK, Palandri, L, Bernardi, S, Bruzzese, E, Badolato, R, Gabiano, C, Chiappini, E, De Martino, M, Galli, L, and Osimani, Patrizia

Subjects
HIV infection transmission, VERTICAL transmission (Communicable diseases), HIV infections, HIV-positive persons, INFANT formulas, MOTHERS, ANTIRETROVIRAL agents, EARLY diagnosis, PREVENTION
Abstract

Objectives: Vertical transmission of HIV can be effectively controlled through antenatal screening, antiretroviral treatment and the services provided during and after childbirth for mother and newborn. In Italy, the National Health Service guarantees universal access to prenatal care for all women, including women with HIV infection. Despite this, children are diagnosed with HIV infection every year. The aim of the study was to identify missed opportunities for prevention of mother‐to‐child transmission of HIV. Methods: The Italian Register for HIV Infection in Children, which was started in 1985 and involves 106 hospitals throughout the country, collects data on all new cases of HIV infection in children. For this analysis, we reviewed the database for the period 2005 to 2015. Results: We found 79 HIV‐1‐infected children newly diagnosed after birth in Italy. Thirty‐two of the mothers were Italian. During the pregnancy, only 15 of 19 women with a known HIV diagnosis were treated with antiretroviral treatment, while, of 34 women who had received an HIV diagnosis before labour began, only 23 delivered by caesarean section and 17 received intrapartum prophylaxis. In 25 mothers, HIV infection was diagnosed during pregnancy or in the peripartum period. Thirty‐one newborns received antiretroviral prophylaxis and 39 received infant formula. Conclusions: We found an unacceptable number of missed opportunities to prevent mother‐to‐child transmission (MCTC). Eliminating HIV MTCT is a universal World Health Organization goal. Elucidating organization failures in Italy over the past decade should help to improve early diagnosis and to reach the zero transmission target in newborns. [ABSTRACT FROM AUTHOR]

Published
2019
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16. Menisküs lezyonları: Haliyle bırakma, sütür veya menisektomi. Biomekanik ve histokimyasal özellikleri

Author

Felli, L., Schiappacasse, S., and Burastero, G.

Subjects
meniscal lesions
Abstract

The meniscus represents the main structure for distributing mechanical stress in the knee joint. It is easy to understand that preservation of meniscus is the first step to avoid cartilage injuries and consequently osteoarthritis of the compartments. We wainted to check how much a particular lesion treatment of the meniscus behaves, considering the presence and the absence of undamaged cartilage. using personal cases. We concluded that retarinment through meniscus suturing is the best choice when conditions allowfor such., Menisküs, diz ekleminde mekanik stresleri dağıtan yapıdır. Kıkırdak hasarı ve bunun sonucunda osteoartritten korunmak için ilk adım meniskusların korunmasıdır. Biz kişisel vakalar kullanarak. kıkırdak lezyonu olup olmamasını gözönüne alarak, menisküs lezyonlarının tedavisini araştırdık. Eğer şartlar uygun olursa, diz menisküs dikişiyle menisküsün bırakılmasının en iyi seçenek olduğuna inanmaktayız.

Published
2014

17. Cyclic ADP-Ribose-Mediated Expansion and Stimulation of Human Mesenchymal Stem Cells by the Plant Hormone Abscisic Acid

Author

Scarfì S, Ferraris C, Fruscione F, Fresia C, Guida L, Bruzzone S, Usai C, Parodi A, Millo E, Salis A, Burastero G, De Flora A, and Zocchi E.

Subjects
organic chemicals, fungi, food and beverages
Abstract

Abscisic acid (ABA) is a phytohormone involved in fundamental processes in higher plants. Endogenous ABA biosynthesis occurs also in lower Metazoa, in which ABA regulates several physiological functions by activating ADP-ribosyl cyclase (ADPRC) and causing overproduction of the Ca(2+)-mobilizing second messenger cyclic ADP-ribose (cADPR), thereby enhancing intracellular Ca(2+) concentration ([Ca(2+)](i)). Recently, production and release of ABA have been demonstrated to take place also in human granulocytes, where ABA behaves as a proinflammatory hormone through the same cADPR/[Ca(2+)](i) signaling pathway described in plants and in lower Metazoa. On the basis of the fact that human mesenchymal stem cells (MSC) express ADPRC activity, we investigated the effects of ABA and of its second messenger, cADPR, on purified human MSC. Both ABA and cADPR stimulate the in vitro expansion of MSC without affecting differentiation. The underlying mechanism involves a signaling cascade triggered by ABA binding to a plasma membrane receptor and consequent cyclic AMP-mediated activation of ADPRC and of the cADPR/[Ca(2+)](i) system. Moreover, ABA stimulates the following functional activities of MSC: cyclooxygenase 2-catalyzed production of prostaglandin E(2) (PGE(2)), release of several cytokines known to mediate the trophic and immunomodulatory properties of MSC, and chemokinesis. Remarkably, ABA proved to be produced and released by MSC stimulated by specific growth factors (e.g., bone morphogenetic protein-7), by inflammatory cytokines, and by lymphocyte-conditioned medium. These data demonstrate that ABA is an autocrine stimulator of MSC function and suggest that it may participate in the paracrine signaling among MSC, inflammatory/immune cells, and hemopoietic progenitors. Disclosure of potential conflicts of interest is found at the end of this article.

Published
2008

21. Protesi oggi e stato dell'arte

Author

Felli, Lamberto, Picchetta, F., Rainuzzi, R., and Burastero, G.

Subjects
artroprotesi totale, Artrite reumatoide, coxartrosi, gonartrosi
Published
1998

27. La sinoviectomia nel polso reumatoide

Author

Felli, Lamberto, Michelis, M. B., Scutellà, C., and Burastero, G.

Subjects
TRATTAMENTO CHIRURGICO DEL POLSO REUMATOIDE, SINOVIECTOMIA
Published
1996

36. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial

Author

Carlo Salvarani, Marco Massari, Massimo Costantini, Domenico Franco Merlo, Gabriella Lucia Mariani, Pierluigi Viale, Stefano Nava, Giovanni Guaraldi, Giovanni Dolci, Luca Boni, Luisa Savoldi, Paolo Bruzzi, Caterina Turrà, Mariagrazia Catanoso, Anna Maria Marata, Chiara Barbieri, Annamaria Valcavi, Francesca Franzoni, Silvio Cavuto, Giorgio Mazzi, Romina Corsini, Fabio Trapani, Alessandro Bartoloni, Emanuela Barisione, Giulia Jole Burastero, Angelo Pan, Walter Inojosa, Raffaele Scala, Cecilia Burattini, Fabrizio Luppi, Mauro Codeluppi, Kamal Eldin Tarek, Giovanni Cenderello, Mario Salio, Giuseppe Foti, Roberto Dongilli, Gianluigi Bajocchi, Emanuele Alberto Negri, Giacomo Ciusa, Giacomo Fornaro, Ilaria Bassi, Lorenzo Zammarchi, Teresita Aloè, Nicola Facciolongo, Salvarani, C, Massari, M, Costantini, M, Franco Merlo, D, Lucia Mariani, G, Viale, P, Nava, S, Guaraldi, G, Dolci, G, Boni, L, Savoldi, L, Bruzzi, P, Turrà, C, Catanoso, M, Maria Marata, A, Barbieri, C, Valcavi, A, Franzoni, F, Cavuto, S, Mazzi, G, Corsini, R, Trapani, F, Bartoloni, A, Barisione, E, Jole Burastero, G, Pan, A, Inojosa, W, Scala, R, Burattini, C, Luppi, F, Codeluppi, M, Eldin Tarek, K, Cenderello, G, Salio, M, Foti, G, Dongilli, R, Bajocchi, G, Alberto Negri, E, Ciusa, G, Fornaro, G, Bassi, I, Zammarchi, L, Aloè, T, and Facciolongo, N

Subjects
Oxygen, Pulmonary and Respiratory Medicine, Treatment Outcome, Double-Blind Method, SARS-CoV-2, Humans, COVID-19, methylprednisolone, steroids, pneumonia, Methylprednisolone, Glucocorticoids, COVID-19 Drug Treatment
Abstract

RationalePulse glucocorticoid therapy is used in hyperinflammation related to coronavirus disease 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia.MethodsIn this multicentre, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with COVID-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for three consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need for supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival.ResultsOverall, 112 (75.4%) out of 151 patients in the pulse methylprednisolone arm and 111 (75.2%) of 150 in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups (15 days, 95% CI 13.0–17.0 days and 16 days, 95% CI 13.8–18.2 days, respectively; hazard ratio (HR) 0.92, 95% CI 0.71–1.20; p=0.528). No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to intensive care unit with orotracheal intubation or death (20.0%versus16.1%; HR 1.26, 95% CI 0.74–2.16; p=0.176) or overall mortality (10.0%versus12.2%; HR 0.83, 95% CI 0.42–1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups.ConclusionsMethylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.

Published
2022

37. Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

Author

François-Xavier Lescure, Hitoshi Honda, Robert A Fowler, Jennifer Sloane Lazar, Genming Shi, Peter Wung, Naimish Patel, Owen Hagino, Ignacio J. Bazzalo, Marcelo M. Casas, Sebastián A. Nuñez, Yael Pere, Carlos M. Ibarrola, Marco A. Solis Aramayo, Maria C. Cuesta, Andrea E. Duarte, Pablo M. Gutierrez Fernandez, Maria A. Iannantuono, Erica A. Miyazaki, Javier P. Silvio, Dario G. Scublinsky, Alessandra Bales, Daniela Catarino, Elie Fiss, Sara Mohrbacher, Victor Sato, Antonio Baylao, Adilson Cavalcante, Francini Correa, Celso A. de Andrade, Juvencio Furtado, Nelson Ribeiro Filho, Valéria Telles, Leopoldo T. Trevelin, Ricardo Vipich, Rodrigo Boldo, Paula Borges, Suzana Lobo, Graziela Luckemeyer, Luana Machado, Maysa B. Alves, Ana C. Iglessias, Marianna M. Lago, Daniel W. Santos, Hugo Chapdelaine, Emilia L. Falcone, Rahima Jamal, Me-Linh Luong, Madeleine Durand, Stephane Doucet, François-Martin Carrier, Bryan A. Coburn, Lorenzo Del Sorbo, Sharon L. Walmsley, Sara Belga, Luke Y. Chen, Allison D. Mah, Theodore Steiner, Alissa J. Wright, J. Hajek, Neill Adhikari, Robert A. Fowler, Nick Daneman, Kosar A. Khwaja, Jason Shahin, Carolina Gonzalez, Rafael Silva, Marcelo Lindh, Gabriel Maluenda, Patricia Fernandez, Maite Oyonarte, Martin Lasso, Alexandre Boyer, Didier Bronnimann, Hoang-Nam Bui, Charles Cazanave, Helene Chaussade, Arnaud Desclaux, Mailys Ducours, Alexandre Duvignaud, Denis Malvy, Lisa Martin, Didier Neau, Duc Nguyen, Thierry Pistone, Gaetane Soubrane-Wirth, Julie Leitao, Clotilde Allavena, Charlotte Biron, Sabelline Bouchez, Benjamin Gaborit, Antoine Gregoire, Paul Le Turnier, Anne-Sophie Lecompte, Raphael Lecomte, Maeva Lefebvre, Francois Raffi, David Boutoille, Pascale H. Morineau, Romain Guéry, Emmanuel Chatelus, Nathalie Dumoussaud, Renaud Felten, Florina Luca, Bernard Goichot, Francis Schneider, Marie-Caroline Taquet, Matthieu Groh, Mathilde Roumier, Mathilde Neuville, Antoine Bachelard, Valentina Isernia, F-Xavier Lescure, Bao-Chau Phung, Anne Rachline, Aurelie Sautereau, Dorothee Vallois, Yves Bleher, Delphine Boucher, Clémentine Coudon, Jean Esnault, Thomas Guimard, Sophie Leautez-Nainville, Dominique Merrien, Marine Morrier, Pauline Motte-Vincent, Romain Gabeff, Hélène Leclerc, Céline Cozic, Romain Decours, Ronan Février, Gwenhael Colin, Sophie Abgrall, Dorothee Vignes, Raluca Sterpu, Mira Kuellmar, Melanie Meersch-Dini, Raphael Weiss, Alexander Zarbock, Christiane Antony, Marc Berger, Thorsten Brenner, Christian Taube, Frank Herbstreit, Sebastian Dolff, Margarethe Konik, Karsten Schmidt, Markus Zettler, Oliver Witzke, Boris Boell, Jorge Garcia Borrega, Philipp Koehler, Thomas Zander, Fabian Dusse, Othman Al-Sawaf, Philipp Köhler, Dennis Eichenauer, Matthias Kochanek, Alexander Shimabukuro-Vornhagen, Sibylle Mellinghoff, Annika Claßen, Jan-Michel Heger, Charlotte Meyer-Schwickerath, Paul Liedgens, Katrin Heindel, Ana Belkin, Asaf Biber, Mayan Gilboa, Itzchak Levy, Vladislav Litachevsky, Galia Rahav, Anat Finesod Wiedner, Tal Zilberman-Daniels, Yonatan Oster, Jacob Strahilevitz, Sigal Sviri, Elena M. Baldissera, Corrado Campochiaro, Giulio Cavalli, Lorenzo Dagna, Giacomo De Luca, Emanuel Della Torre, Alessandro Tomelleri, Davide Bernasconi De Luca, Amedeo F. Capetti, Massimo Coen, Maria V. Cossu, Massimo Galli, Andrea Giacomelli, Guido A. Gubertini, Stefano Rusconi, Giulia J. Burastero, Margherita Digaetano, Giovanni Guaraldi, Marianna Meschiari, Cristina Mussini, Cinzia Puzzolante, Sara Volpi, Marina Aiello, Alarico Ariani, Alfredo A. Chetta, Annalisa Frizzelli, Andrea Ticinesi, Domenico Tuttolomondo, Stefano Aliberti, Francesco B. Blasi, Marta F. Di Pasquale, Sofia Misuraca, Tommaso Pilocane, Edoardo Simonetta, Alessio M. Aghelmo, Claudio Angelini, Enrico Brunetta, Giorgio W. Canonica, Michele Ciccarelli, Sara Dal Farra, Maria De Santis, Sebastian Ferri, Marco Folci, Giacomo M. Guidelli, Enrico M. Heffler, Ferdinando Loiacono, Giacomo Malipiero, Giovanni Paoletti, Rosa Pedale, Francesca A. Puggioni, Francesca Racca, Aurora Zumbo, Morihiko Satou, Tatyana Lisun, Denis Protsenko, Nikolay Rubtsov, Irina Beloglazova, Daria Fomina, Mariana Lysenko, Sofia Serdotetskova, Vitali Firstov, Ivan Gordeev, Ilia Kokorin, Ksenia Komissarova, Nina Lapochkina, Elena Luchinkina, Valentin Malimon, Sevinch Mamedguseyinova, Ksenia Polubatonova, Natalia Suvorova, Jose Arribas, Alberto M. Borobia Perez, Fernando de la Calle Prieto, Juan Carlos Figueira, Rocio Motejano Sanchez, Marta Mora-Rillo, Concepcion Prados Sanchez, Javier Queiruga Parada, Francisco Fernandez Arnalich, Maria Guerro Barrientos, Alejandro Bendala Estrada, Aranzazu Caballero Marcos, Maria E. Garcia Leoni, Rita García-Martínez, Ana María Collado, Patricia Munoz Garcia, Ana Torres do Rego, María V. Villalba García, Almudena Burrillo, Maricela Valerio Minero, Paloma Gijon Vidaurreta, Sonsoles Infante Herrero, Elena Velilla, Marina Machado, Maria Olmedo, Blanca Pinilla, Benito Almirante Gragera, Maria de la Esperanza Cañas Ruano, Sofia Contreras Medina, Alejandro Cortés Herrera, Vicenç Falcó Ferrer, Ricard Ferrer Roca, Xavier Nuvials Casals, Esteve Ribera Pascuet, Paula Suanzes Diez, Pedro Rebollo Castro, Felipe Garcia Alcaide, Alejandro Soriano, Aina Oliver Caldes, Ana González Cordón, Celia Cardozo, Lorena De la Mora Cañizo, Romina Pena López, Sandra Chamorro, Clara Crespillo-Andujar, Rosa Escudero Sanchez, Jesús Fortún-Abete, Begoña Monge-Maillo, Ana Moreno Zamora, Francesca Norman, Matilde Sanchez Conde, Sergio Serrano Villar, Pilar Vizcarra, Lescure, F. -X., Honda, H., Fowler, R. A., Lazar, J. S., Shi, G., Wung, P., Patel, N., Hagino, O., Bazzalo, I. J., Casas, M. M., Nunez, S. A., Pere, Y., Ibarrola, C. M., Solis Aramayo, M. A., Cuesta, M. C., Duarte, A. E., Gutierrez Fernandez, P. M., Iannantuono, M. A., Miyazaki, E. A., Silvio, J. P., Scublinsky, D. G., Bales, A., Catarino, D., Fiss, E., Mohrbacher, S., Sato, V., Baylao, A., Cavalcante, A., Correa, F., de Andrade, C. A., Furtado, J., Ribeiro Filho, N., Telles, V., Trevelin, L. T., Vipich, R., Boldo, R., Borges, P., Lobo, S., Luckemeyer, G., Machado, L., Alves, M. B., Iglessias, A. C., Lago, M. M., Santos, D. W., Chapdelaine, H., Falcone, E. L., Jamal, R., Luong, M. -L., Durand, M., Doucet, S., Carrier, F. -M., Coburn, B. A., Del Sorbo, L., Walmsley, S. L., Belga, S., Chen, L. Y., Mah, A. D., Steiner, T., Wright, A. J., Hajek, J., Adhikari, N., Daneman, N., Khwaja, K. A., Shahin, J., Gonzalez, C., Silva, R., Lindh, M., Maluenda, G., Fernandez, P., Oyonarte, M., Lasso, M., Boyer, A., Bronnimann, D., Bui, H. -N., Cazanave, C., Chaussade, H., Desclaux, A., Ducours, M., Duvignaud, A., Malvy, D., Martin, L., Neau, D., Nguyen, D., Pistone, T., Soubrane-Wirth, G., Leitao, J., Allavena, C., Biron, C., Bouchez, S., Gaborit, B., Gregoire, A., Le Turnier, P., Lecompte, A. -S., Lecomte, R., Lefebvre, M., Raffi, F., Boutoille, D., Morineau, P. H., Guery, R., Chatelus, E., Dumoussaud, N., Felten, R., Luca, F., Goichot, B., Schneider, F., Taquet, M. -C., Groh, M., Roumier, M., Neuville, M., Bachelard, A., Isernia, V., Phung, B. -C., Rachline, A., Sautereau, A., Vallois, D., Bleher, Y., Boucher, D., Coudon, C., Esnault, J., Guimard, T., Leautez-Nainville, S., Merrien, D., Morrier, M., Motte-Vincent, P., Gabeff, R., Leclerc, H., Cozic, C., Decours, R., Fevrier, R., Colin, G., Abgrall, S., Vignes, D., Sterpu, R., Kuellmar, M., Meersch-Dini, M., Weiss, R., Zarbock, A., Antony, C., Berger, M., Brenner, T., Taube, C., Herbstreit, F., Dolff, S., Konik, M., Schmidt, K., Zettler, M., Witzke, O., Boell, B., Garcia Borrega, J., Koehler, P., Zander, T., Dusse, F., Al-Sawaf, O., Kohler, P., Eichenauer, D., Kochanek, M., Shimabukuro-Vornhagen, A., Mellinghoff, S., Classen, A., Heger, J. -M., Meyer-Schwickerath, C., Liedgens, P., Heindel, K., Belkin, A., Biber, A., Gilboa, M., Levy, I., Litachevsky, V., Rahav, G., Finesod Wiedner, A., Zilberman-Daniels, T., Oster, Y., Strahilevitz, J., Sviri, S., Baldissera, E. M., Campochiaro, C., Cavalli, G., Dagna, L., De Luca, Giacomo., Della Torre, E., Tomelleri, A., Bernasconi De Luca, D., Capetti, A. F., Coen, M., Cossu, M. V., Galli, M., Giacomelli, A., Gubertini, G. A., Rusconi, S., Burastero, G. J., Digaetano, M., Guaraldi, G., Meschiari, M., Mussini, C., Puzzolante, C., Volpi, S., Aiello, M., Ariani, A., Chetta, A. A., Frizzelli, A., Ticinesi, A., Tuttolomondo, D., Aliberti, S., Blasi, F. B., Di Pasquale, M. F., Misuraca, S., Pilocane, T., Simonetta, E., Aghelmo, A. M., Angelini, C., Brunetta, E., Canonica, G. W., Ciccarelli, M., Dal Farra, S., De Santis, M., Ferri, S., Folci, M., Guidelli, G. M., Heffler, E. M., Loiacono, F., Malipiero, G., Paoletti, G., Pedale, R., Puggioni, F. A., Racca, F., Zumbo, A., Satou, M., Lisun, T., Protsenko, D., Rubtsov, N., Beloglazova, I., Fomina, D., Lysenko, M., Serdotetskova, S., Firstov, V., Gordeev, I., Kokorin, I., Komissarova, K., Lapochkina, N., Luchinkina, E., Malimon, V., Mamedguseyinova, S., Polubatonova, K., Suvorova, N., Arribas, J., Borobia Perez, A. M., de la Calle Prieto, F., Figueira, J. C., Motejano Sanchez, R., Mora-Rillo, M., Prados Sanchez, C., Queiruga Parada, J., Fernandez Arnalich, F., Guerro Barrientos, M., Bendala Estrada, A., Caballero Marcos, A., Garcia Leoni, M. E., Garcia-Martinez, R., Collado, A. M., Munoz Garcia, P., Torres do Rego, A., Villalba Garcia, M. V., Burrillo, A., Valerio Minero, M., Gijon Vidaurreta, P., Infante Herrero, S., Velilla, E., Machado, M., Olmedo, M., Pinilla, B., Almirante Gragera, B., Canas Ruano, M. D. L. E., Contreras Medina, S., Cortes Herrera, A., Falco Ferrer, V., Ferrer Roca, R., Nuvials Casals, X., Ribera Pascuet, E., Suanzes Diez, P., Rebollo Castro, P., Garcia Alcaide, F., Soriano, A., Oliver Caldes, A., Gonzalez Cordon, A., Cardozo, C., De la Mora Canizo, L., Pena Lopez, R., Chamorro, S., Crespillo-Andujar, C., Escudero Sanchez, R., Fortun-Abete, J., Monge-Maillo, B., Moreno Zamora, A., Norman, F., Sanchez Conde, M., Serrano Villar, S., and Vizcarra, P.

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Critical Care, International Cooperation, Population, Antibodies, Monoclonal, Humanized, Placebo, Severity of Illness Index, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Intensive care, Severity of illness, medicine, Clinical endpoint, Humans, Immunologic Factors, 030212 general & internal medicine, Mortality, education, Respiratory Distress Syndrome, education.field_of_study, Dose-Response Relationship, Drug, SARS-CoV-2, business.industry, Hazard ratio, COVID-19, Articles, Middle Aged, Receptors, Interleukin-6, Sarilumab, Treatment Outcome, 030228 respiratory system, Female, Drug Monitoring, Cytokine Release Syndrome, business
Abstract

Summary Background Elevated proinflammatory cytokines are associated with greater COVID-19 severity. We aimed to assess safety and efficacy of sarilumab, an interleukin-6 receptor inhibitor, in patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19. Methods We did a 60-day, randomised, double-blind, placebo-controlled, multinational phase 3 trial at 45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain. We included adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care. Patients were randomly assigned (2:2:1 with permuted blocks of five) to receive intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo. Patients, care providers, outcome assessors, and investigators remained masked to assigned intervention throughout the course of the study. The primary endpoint was time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital]) in the modified intention-to-treat population. The key secondary endpoint was proportion of patients alive at day 29. Safety outcomes included adverse events and laboratory assessments. This study is registered with ClinicalTrials.gov, NCT04327388; EudraCT, 2020-001162-12; and WHO, U1111-1249-6021. Findings Between March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received placebo (n=84 [20%]), sarilumab 200 mg (n=159 [38%]), or sarilumab 400 mg (n=173 [42%]). At day 29, no significant differences were seen in median time to an improvement of two or more points between placebo (12·0 days [95% CI 9·0 to 15·0]) and sarilumab 200 mg (10·0 days [9·0 to 12·0]; hazard ratio [HR] 1·03 [95% CI 0·75 to 1·40]; log-rank p=0·96) or sarilumab 400 mg (10·0 days [9·0 to 13·0]; HR 1·14 [95% CI 0·84 to 1·54]; log-rank p=0·34), or in proportions of patients alive (77 [92%] of 84 patients in the placebo group; 143 [90%] of 159 patients in the sarilumab 200 mg group; difference −1·7 [−9·3 to 5·8]; p=0·63 vs placebo; and 159 [92%] of 173 patients in the sarilumab 400 mg group; difference 0·2 [−6·9 to 7·4]; p=0·85 vs placebo). At day 29, there were numerical, non-significant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +8·9% [95% CI −7·7 to 25·5]; p=0·25) for patients who had critical disease. No unexpected safety signals were seen. The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group. Interpretation This trial did not show efficacy of sarilumab in patients admitted to hospital with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19. Funding Sanofi and Regeneron Pharmaceuticals.

Published
2021

38. The impact of tocilizumab on respiratory support states transition and clinical outcomes in COVID-19 patients. A Markov model multi-state study

Author

Giovanni Guaraldi, Gianluca Cuomo, Marianna Meschiari, Andrea Cossarizza, Massimo Girardis, Cristina Mussini, Stefano Busani, Luca Corradi, Alessandro Raimondi, Erica Bacca, Erica Franceschini, Giovanni Dolci, Margherita Digaetano, Antonella Santoro, Giacomo Ciusa, Dina Yaacoub, Marianna Menozzi, Sara Volpi, Marco Tutone, Cinzia Puzzolante, Gabriella Orlando, Giacomo Franceschi, Jovana Milic, Andrea Bedini, Licia Gozzi, Federico Banchelli, Vittorio Iadisernia, Giulia Burastero, Roberto D'Amico, Federica Carli, Matteo Faltoni, Rossella Miglio, Carlotta Rogati, Milic J., Banchelli F., Meschiari M., Franceschini E., Ciusa G., Gozzi L., Volpi S., Faltoni M., Franceschi G., Iadisernia V., Yaacoub D., Dolci G., Bacca E., Rogati C., Tutone M., Burastero G., Raimondi A., Menozzi M., Cuomo G., Corradi L., Orlando G., Santoro A., Digaetano M., Puzzolante C., Carli F., Bedini A., Busani S., Girardis M., Cossarizza A., Miglio R., Mussini C., Guaraldi G., and D'Amico R.

Subjects
Male, medicine.medical_specialty, Respiratory Therapy, Time Factors, Time Factor, medicine.medical_treatment, Science, Antibodies, Monoclonal, Humanized, law.invention, chemistry.chemical_compound, Tocilizumab, Randomized controlled trial, law, Oxygen therapy, Internal medicine, medicine, Humans, Aged, Mechanical ventilation, Multidisciplinary, Noninvasive Ventilation, business.industry, Mortality rate, Oxygen Inhalation Therapy, COVID-19, Markov Chain, Middle Aged, medicine.disease, Respiration, Artificial, Markov Chains, COVID-19 Drug Treatment, Pneumonia, Treatment Outcome, chemistry, Breathing, Medicine, Observational study, Female, business, Research Article, Human
Abstract

Background The benefit of tocilizumab on mortality and time to recovery in people with severe COVID pneumonia may depend on appropriate timing. The objective was to estimate the impact of tocilizumab administration on switching respiratory support states, mortality and time to recovery. Methods In an observational study, a continuous-time Markov multi-state model was used to describe the sequence of respiratory support states including: no respiratory support (NRS), oxygen therapy (OT), non-invasive ventilation (NIV) or invasive mechanical ventilation (IMV), OT in recovery, NRS in recovery. Results Two hundred seventy-one consecutive adult patients were included in the analyses contributing to 695 transitions across states. The prevalence of patients in each respiratory support state was estimated with stack probability plots, comparing people treated with and without tocilizumab since the beginning of the OT state. A positive effect of tocilizumab on the probability of moving from the invasive and non-invasive mechanical NIV/IMV state to the OT in recovery state (HR = 2.6, 95% CI = 1.2–5.2) was observed. Furthermore, a reduced risk of death was observed in patients in NIV/IMV (HR = 0.3, 95% CI = 0.1–0.7) or in OT (HR = 0.1, 95% CI = 0.0–0.8) treated with tocilizumab. Conclusion To conclude, we were able to show the positive impact of tocilizumab used in different disease stages depicted by respiratory support states. The use of the multi-state Markov model allowed to harmonize the heterogeneous mortality and recovery endpoints and summarize results with stack probability plots. This approach could inform randomized clinical trials regarding tocilizumab, support disease management and hospital decision making.

Published
2021

39. Two-stage total joint replacement for hip or knee septic arthritis: post-traumatic etiology and difficult-to-treat infections predict poor outcomes.

Author

Russo A, Migliorini F, Giustra F, Bosco F, Massè A, and Burastero G

Subjects
Humans, Male, Female, Retrospective Studies, Middle Aged, Aged, Prosthesis-Related Infections etiology, Prosthesis-Related Infections surgery, Adult, Treatment Outcome, Treatment Failure, Knee Joint surgery, Aged, 80 and over, Arthritis, Infectious surgery, Arthritis, Infectious etiology, Arthritis, Infectious microbiology, Arthroplasty, Replacement, Knee adverse effects, Arthroplasty, Replacement, Hip adverse effects
Abstract

Purpose: Septic arthritis (SA) is a rare but significant clinical challenge in orthopedics that can impact patients' quality of life. This study aims to examine the clinical outcomes of patients undergoing two-stage total joint replacement (TJR) in hip and knee SA and analyze potential predictors of treatment failure., Methods: A retrospective analysis was conducted using data from a prospectively collected institutional arthroplasty registry from January 1st, 2012, to January 1st, 2019. Patients with hip or knee SA who underwent a two-stage TJR and had at least two years of follow-up were included. Demographic characteristics, surgical variables, and outcomes were collected and analyzed from clinical and surgical data. Statistical analysis was performed using IBM SPSS Statistics, with statistical significance at p < 0.05., Results: One hundred and fourteen patients (61 with hip SA, 53 with knee SA) were included in the study. The mean follow-up was 72.8 months. Postoperatively, both clinical and functional outcomes significantly improved, as indicated by the Hip Society Score (HHS) and Knee Society Score (KSS). The overall success rate of the two-stage protocol was 89.5%. Complications that did not require revision occurred in 21% of cases. The most identified pathogen was methicillin-sensitive Staphylococcus aureus (MSSA). Difficult-to-treat (DTT) infections and post-traumatic etiology were identified as predictors of treatment failure in patients undergoing two-stage TJR for hip and knee SA., Conclusions: Two-stage TJR in hip and knee SA demonstrated favorable clinical outcomes at mid-term follow-up. The procedure significantly improved functional scores and achieved a high success rate, while DTT infections and post-traumatic etiology were associated with a higher risk of treatment failure., Competing Interests: Declarations. Ethical approval: The author’s institution’s Institutional Review Board (IRB) defined this study as exempt from IRB approval (retrospective study of an established surgical procedure). It was conducted following the ethical standards of the Declaration of Helsinki (1964), and written informed consent was obtained from all participants included in the study. Informed consent: All patients were informed about the study and consented to participate. Conflict of interest: All authors have no conflicts of interest for this study to disclose., (© 2024. The Author(s).)

Published
2024
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40. Unbalanced metaphyseal fixation is associated with an increased aseptic loosening of revision total knee arthroplasty at mean 4-year follow-up.

Author

Russo A, Alessio-Mazzola M, Massè A, and Burastero G

Subjects
Humans, Aged, Middle Aged, Female, Retrospective Studies, Male, Aged, 80 and over, Adult, Follow-Up Studies, Prosthesis-Related Infections surgery, Prosthesis-Related Infections etiology, Femur surgery, Tibia surgery, Arthroplasty, Replacement, Knee adverse effects, Arthroplasty, Replacement, Knee methods, Reoperation statistics & numerical data, Prosthesis Failure, Knee Prosthesis adverse effects
Abstract

Introduction: The total number of total knee arthroplasty performed is rising, and the number of revisions is rising accordingly. Periprosthetic joint infection emerged in recent years as a leading cause of total knee revisions. Bone loss is a real challenge when facing septic knee revisions since radical debridement is crucial to overcome infection. Many devices have already demonstrated to reliably address bone loss and guarantee enhanced fixation. However, the role of balancing metaphyseal fixation and its interplay with the level of constraint has not been elucidated yet., Material and Methods: An institutional arthroplasty registry was retrospectively reviewed looking for patients who underwent two-stage revision of the knee and metaphyseal cones implantation. Patients were divided into two groups based on the presence of cones only on one side (femoral or tibial, Group U) or both femoral and tibial side (Group B). Failure, aseptic loosening, and revision rates were compared between groups, as were values of patient-reported outcome measure. Kaplan-Meier analysis was used to assess survival of implants., Results: A total of 65 patients were included in the analysis and were evaluated at a mean final follow-up of 4 years (range, 2-7). Mean age was 67 (range, 43-81) years. Mean BMI was 27.4 (range, 20-37) kg/m 2 . The overall mean KSS, OKS, ROM significantly increased from baseline values to last follow-up (p < 0.001). Kaplan-Meier analysis demonstrated that patients included in Group U had a significantly lower rate of implant survival compared to those included in Group B., Conclusions: Patients undergoing revision total knee arthroplasty for periprosthetic infection present considerable rates of complication and failure. Management of bone loss represents a concern for the surgeon, who must achieve a stable fixation. Our study demonstrated that implants characterized by an unbalanced metaphyseal fixation are at higher risk of aseptic loosening and consequent revision, especially when coupled with hinged inserts., Competing Interests: Declarations. Conflicts of interest: The authors declare that there is no conflict of interest. Ethics approval: Approved by the local institutional review board. Consent to participate: Patients gave their informed consent to participate this study. Consent for publication: Patients gave their consent to publish clinical data contained in this study., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2024
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41. Intravenous fosfomycin in combination regimens as a treatment option for difficult-to-treat infections due to multi-drug-resistant Gram-negative organisms: A real-life experience.

Author

Meschiari M, Faltoni M, Kaleci S, Tassoni G, Orlando G, Franceschini E, Burastero G, Bedini A, Serio L, Biagioni E, Melegari G, Venturelli C, Sarti M, Bertellini E, Girardis M, and Mussini C

Subjects
Humans, Retrospective Studies, Male, Female, Aged, Middle Aged, Gram-Negative Bacteria drug effects, Treatment Outcome, Aged, 80 and over, Tazobactam therapeutic use, Adult, Drug Combinations, Pseudomonas aeruginosa drug effects, Risk Factors, Fosfomycin therapeutic use, Fosfomycin administration & dosage, Gram-Negative Bacterial Infections drug therapy, Gram-Negative Bacterial Infections microbiology, Gram-Negative Bacterial Infections mortality, Drug Resistance, Multiple, Bacterial, Anti-Bacterial Agents therapeutic use, Anti-Bacterial Agents administration & dosage, Drug Therapy, Combination, Administration, Intravenous, Cephalosporins
Abstract

Aim: To investigate the efficacy of intravenous (IV) fosfomycin as combination therapy for treatment of difficult-to-treat (DTT) acute and subacute infections with multi-drug-resistant (MDR) Gram-negative bacteria (GNB), and risk factors associated with 90-day mortality., Methods: A retrospective, observational, monocentric study enrolled patients treated with IV fosfomycin in combination regimens (≥72 h) for proven DTT-MDR-GNB infection. Multi-variate regression analysis identified independent risk factors for 90-day mortality. A propensity score for receiving fosfomycin was performed to control for confounding factors., Results: In total, 70 patients were included in this study: 54.3% had carbapenem-resistant isolates, 31.4% had ceftazidime/avibactam-resistant isolates and 28.6% had ceftolozane/tazobactam-resistant isolates. The main pathogens were Pseudomonas aeruginosa (57.1%) and Klebsiella pneumoniae (22.9%). The most prevalent infections were nosocomial pneumonia (42.9%), osteomyelitis (17.1%) and intra-abdominal infections. All-cause 30- and 90-day mortality were 15.7% and 31.4%, respectively (18.9% and 50% considering acute DTT-MDR-GNB infections alone). Relapse at 30 days occurred in 22.9% of cases (29% with emergence of fosfomycin resistance). Mortality at 90 days was independently associated with septic shock and ceftolozane/tazobactam resistance. The relationship between resistance to ceftolozane/tazobactam and 90-day mortality was confirmed to be significant after adjustment by propensity score analysis (hazard ratio 5.84, 95% confidence interval 1.65-20.68; P=0.006)., Conclusions: Fosfomycin seems to be a promising salvage, combination treatment in DTT-MDR-GNB infections. Resistance to ceftolozane/tazobactam seems to be independently associated with treatment failure. Randomized clinical trials focusing on pathogen and infection sites are needed urgently to demonstrate the superiority of fosfomycin in combination with other agents for the resolution of DTT-MDR-GNB infections., (Copyright © 2024 Elsevier Ltd and International Society of Antimicrobial Chemotherapy. All rights reserved.)

Published
2024
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42. Characterization and outcomes of difficult-to-treat patients starting modern first-line ART regimens: Data from the ICONA cohort.

Author

Gagliardini R, Tavelli A, Rusconi S, Lo Caputo S, Spagnuolo V, Santoro MM, Costantini A, Vergori A, Maggiolo F, Giacomelli A, Burastero G, Madeddu G, Quiros Roldan E, d'Arminio Monforte A, Antinori A, and Cozzi-Lepri A

Subjects
Humans, Treatment Failure, Survival Analysis, Viral Load, Anti-HIV Agents adverse effects, Acquired Immunodeficiency Syndrome drug therapy, HIV Infections drug therapy, HIV Infections epidemiology
Abstract

Objectives: Treatment failures to modern antiretroviral therapy (ART) raise concerns, as they could reduce future options. Evaluations of occurrence of multiple failures to modern ART are missing and their significance in the long run is unclear., Methods: People with HIV (PWH) in the ICONA cohort who started a modern first-line ART were defined as 'difficult to treat' (DTT) if they experienced ≥1 among: i) ≥2 VF (2 viral loads, VL>200 copies/mL or 1 VL>1000 copies/mL) with or without ART change; ii) ≥2 treatment discontinuations (TD) due to toxicity/intolerance/failure; iii) ≥1 VF followed by ART change plus ≥1 TD due to toxicity/intolerance/failure. A subgroup of the DTT participants were matched to PWH that, after the same time, were non-DTT. Treatment response, analysing VF, TD, treatment failure, AIDS/death, and SNAE (Serious non-AIDS event)/death, were compared. Survival analysis by KM curves and Cox regression models were employed., Results: Among 8061 PWH, 320 (4%) became DTT. Estimates of becoming DTT was 6.5% (95% CI: 5.8-7.4%) by 6 years. DTT PWH were significantly older, with a higher prevalence of AIDS and lower CD4+ at nadir than the non-DTT. In the prospective analysis, DTT demonstrated a higher unadjusted risk for all the outcomes. Once controlled for confounders, significant associations were confirmed for VF (aHR 2.23, 1.33-3.73), treatment failure (aHR 1.70, 1.03-2.78), and SNAE/death (aHR 2.79, 1.18-6.61)., Conclusion: A total of 6.5% of PWH satisfied our definition of DTT by 6 years from ART starting. This appears to be a more fragile group who may have higher risk of failure., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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43. A Machine Learning Approach to Predict Weight Change in ART-Experienced People Living With HIV.

Author

Motta F, Milic J, Gozzi L, Belli M, Sighinolfi L, Cuomo G, Carli F, Dolci G, Iadisernia V, Burastero G, Mussini C, Missier P, Mandreoli F, and Guaraldi G

Subjects
Humans, Male, Middle Aged, Female, Body Composition, Weight Gain, Machine Learning, HIV Infections drug therapy
Abstract

Introduction: The objective of the study was to develop machine learning (ML) models that predict the percentage weight change in each interval of time in antiretroviral therapy-experienced people living with HIV., Methods: This was an observational study that comprised consecutive people living with HIV attending Modena HIV Metabolic Clinic with at least 2 visits. Data were partitioned in an 80/20 training/test set to generate 10 progressively parsimonious predictive ML models. Weight gain was defined as any weight change >5%, at the next visit. SHapley Additive exPlanations values were used to quantify the positive or negative impact of any single variable included in each model on the predicted weight changes., Results: A total of 3,321 patients generated 18,322 observations. At the last observation, the median age was 50 years and 69% patients were male. Model 1 (the only 1 including body composition assessed with dual-energy x-ray absorptiometry) had an accuracy greater than 90%. This model could predict weight at the next visit with an error of <5%., Conclusions: ML models with the inclusion of body composition and metabolic and endocrinological variables had an excellent performance. The parsimonious models available in standard clinical evaluation are insufficient to obtain reliable prediction, but are good enough to predict who will not experience weight gain., Competing Interests: G.G. and C.M. received research grant and speaker honorarium from Gilead, ViiV, MERCK, and Jansen. G.G. and C.M. attended advisory boards of Gilead, ViiV, and MERCK. Other authors reported no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2023
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44. Quality of life and intrinsic capacity in patients with post-acute COVID-19 syndrome is in relation to frailty and resilience phenotypes.

Author

Guaraldi G, Milic J, Barbieri S, Marchiò T, Caselgrandi A, Motta F, Beghè B, Verduri A, Belli M, Gozzi L, Iadisernia V, Faltoni M, Burastero G, Dessilani A, Del Monte M, Dolci G, Bacca E, Franceschi G, Yaacoub D, Volpi S, Mazzochi A, Clini E, and Mussini C

Subjects
Humans, Aged, Frail Elderly, Quality of Life, Cross-Sectional Studies, Post-Acute COVID-19 Syndrome, Geriatric Assessment, Frailty, COVID-19
Abstract

The objective of this study was to characterize frailty and resilience in people evaluated for Post-Acute COVID-19 Syndrome (PACS), in relation to quality of life (QoL) and Intrinsic Capacity (IC). This cross-sectional, observational, study included consecutive people previously hospitalized for severe COVID-19 pneumonia attending Modena (Italy) PACS Clinic from July 2020 to April 2021. Four frailty-resilience phenotypes were built: "fit/resilient", "fit/non-resilient", "frail/resilient" and "frail/non-resilient". Frailty and resilience were defined according to frailty phenotype and Connor Davidson resilience scale (CD-RISC-25) respectively. Study outcomes were: QoL assessed by means of Symptoms Short form health survey (SF-36) and health-related quality of life (EQ-5D-5L) and IC by means of a dedicated questionnaire. Their predictors including frailty-resilience phenotypes were explored in logistic regressions. 232 patients were evaluated, median age was 58.0 years. PACS was diagnosed in 173 (74.6%) patients. Scarce resilience was documented in 114 (49.1%) and frailty in 72 (31.0%) individuals. Predictors for SF-36 score < 61.60 were the phenotypes "frail/non-resilient" (OR = 4.69, CI 2.08-10.55), "fit/non-resilient" (OR = 2.79, CI 1.00-7.73). Predictors for EQ-5D-5L < 89.7% were the phenotypes "frail/non-resilient" (OR = 5.93, CI 2.64-13.33) and "frail/resilient" (OR = 5.66, CI 1.93-16.54). Predictors of impaired IC (below the mean score value) were "frail/non-resilient" (OR = 7.39, CI 3.20-17.07), and "fit/non-resilient" (OR = 4.34, CI 2.16-8.71) phenotypes. Resilience and frailty phenotypes may have a different impact on wellness and QoL and may be evaluated in people with PACS to identify vulnerable individuals that require suitable interventions., (© 2023. The Author(s).)

Published
2023
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45. Medial gastrocnemius rotational flap for the reconstruction of extensor mechanism disruption in periprosthetic knee infections: a retrospective series with minimum two year follow-up.

Author

Russo A, Clemente A, Massè A, and Burastero G

Subjects
Humans, Adult, Middle Aged, Aged, Retrospective Studies, Follow-Up Studies, Treatment Outcome, Muscle, Skeletal surgery, Knee Joint surgery, Reoperation, Arthroplasty, Replacement, Knee adverse effects, Arthroplasty, Replacement, Knee methods, Knee Prosthesis adverse effects
Abstract

Purpose: Extensor mechanism disruption following total knee arthroplasty has a prevalence ranging from 0.3 to 3%. Its management is challenging, especially in case of associated infection of the prosthetic implant. Surgical options are limited due to the septic process, and the use of allograft or synthetic mesh are not recommended. The aim of this study was to report clinical outcomes, complications, survival, and surgical technique of medial gastrocnemius flap for the treatment of extensor mechanism disruptions associated with periprosthetic knee infection., Methods: This is a retrospective study from a prospectively collected arthroplasty registry from 2012 to 2019. Patients who received the gastrocnemius flap in the setting of a two-stage knee replacement for periprosthetic infection were included. Results of physical examination, Knee Society Score, Oxford Knee Score, and measurement of the range of motion registered pre-operatively were compared to those obtained at last follow-up. Survival was analysed through Kaplan-Meier curve., Results: A total of 15 patients were included, with a mean age of 63.4 years (range 36-77). The reconstruction of the extensor mechanism demonstrated a success rate of 73.3%. The mean extension lag at final follow-up was 7.5° (range, 0-30). The mean Knee Society Score and Oxford Knee Score improved from 29.0 (range, 21-36) and 17.5 (range, 13-22) respectively, to 82.9 (range, 74-89) and 36.0 (range, 33-39)., Conclusion: Medial gastrocnemius rotational flap is a reliable option for joint and limb salvage in case of periprosthetic knee infection associated with wide soft tissue degeneration and extensor mechanism disruption. The technique and surgical protocol presented in this study are reproducible and guaranteed good clinical outcomes and infection control., (© 2023. The Author(s) under exclusive licence to SICOT aisbl.)

Published
2023
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46. Spacer exchange in persistent periprosthetic joint infection: microbiological evaluation and survivorship analysis.

Author

Clemente A, Cavagnaro L, Russo A, Chiarlone F, Massè A, and Burastero G

Subjects
Humans, Middle Aged, Aged, Persistent Infection, Reoperation methods, Retrospective Studies, Anti-Bacterial Agents therapeutic use, Treatment Outcome, Arthroplasty, Replacement, Knee methods, Prosthesis-Related Infections surgery, Arthroplasty, Replacement, Hip methods, Arthritis, Infectious surgery
Abstract

Purpose: The purposes of this study were to determine demographics and characteristics of patients who underwent spacer exchange for persistent infection in the setting of two-stage arthroplasty for periprosthetic joint infection, to describe the microbiology of pathogens involved, to analyze survivorship free from infection in these patients., Methods: The institutional prospectively collected database was reviewed to enroll patients with minimum 2 years follow-up. Patients who underwent two-stage procedure for septic arthritis were excluded, as were patients who had spacer fracture or dislocation., Results: A total of 34 patients (41 procedures) were included. Mean age was 65.0 ± 12.8 years. Mean follow-up was 53.4 ± 24.8 months. Mean number of previous procedures was 3.6 ± 1.2. A total of 27 (79.4%) patients underwent final reimplantation. The most frequently isolated pathogen in spacer exchange was Staphylococcus epidermidis (10 cases, 28.6%). Polymicrobial cultures were obtained from 9 (25.71%) patients, 10 (28.6%) presented culture-negative infections. A total of 11 (32.4%) resistant pathogens were isolated, and 16 (47.0%) difficult to treat pathogens were detected. Eradication rate was 78.8%. Overall survivorship of implants after final reimplantation was 72.8% at 51.8 months., Conclusion: Surgeons should be aware that subjects necessitating spacer exchange often present multiple comorbidities, previous staged revision failures, soft-tissue impairment and difficult to treat infection. In these patients, spacer exchange provides good clinical results and infection eradication, preventing arthrodesis or amputation., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2023
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47. Do All Critically Ill Patients with COVID-19 Disease Benefit from Adding Tocilizumab to Glucocorticoids? A Retrospective Cohort Study.

Author

Mussini C, Cozzi-Lepri A, Meschiari M, Franceschini E, Burastero G, Faltoni M, Franceschi G, Iadisernia V, Volpi S, Dessilani A, Gozzi L, Conti J, Del Monte M, Milic J, Borghi V, Tonelli R, Brugioni L, Romagnoli E, Pietrangelo A, Corradini E, Girardis M, Busani S, Cossarizza A, Clini E, and Guaraldi G

Subjects
Male, Humans, Aged, Female, Critical Illness, Retrospective Studies, COVID-19 Drug Treatment, Glucocorticoids therapeutic use, COVID-19
Abstract

Background: Treatment guidelines recommend the tocilizumab use in patients with a CRP of >7.5 mg/dL. We aimed to estimate the causal effect of glucocorticoids + tocilizumab on mortality overall and after stratification for PaO 2 /FiO 2 ratio and CRP levels., Methods: This was an observational cohort study of patients with severe COVID-19 pneumonia. The primary endpoint was day 28 mortality. Survival analysis was conducted to estimate the conditional and average causal effect of glucocorticoids + tocilizumab vs. glucocorticoids alone using Kaplan-Meier curves and Cox regression models with a time-varying variable for the intervention. The hypothesis of the existence of effect measure modification by CRP and PaO 2 /FiO 2 ratio was tested by including an interaction term in the model., Results: In total, 992 patients, median age 69 years, 72.9% males, 597 (60.2%) treated with monotherapy, and 395 (31.8%), adding tocilizumab upon respiratory deterioration, were included. At BL, the two groups differed for median values of CRP (6 vs. 7 mg/dL; p < 0.001) and PaO 2 /FiO 2 ratio (276 vs. 235 mmHg; p < 0.001). In the unadjusted analysis, the mortality was similar in the two groups, but after adjustment for key confounders, a significant effect of glucocorticoids + tocilizumab was observed (adjusted hazard ratio (aHR) = 0.59, 95% CI: 0.38-0.90). Although the study was not powered to detect interactions ( p = 0.41), there was a signal for glucocorticoids + tocilizumab to have a larger effect in subsets, especially participants with high levels of CRP at intensification., Conclusions: Our data confirm that glucocorticoids + tocilizumab vs. glucocorticoids alone confers a survival benefit only in patients with a CRP > 7.5 mg/dL prior to treatment initiation and the largest effect for a CRP > 15 mg/dL. Large randomized studies are needed to establish an exact cut-off for clinical use.

Published
2023
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48. Clinical radiographic outcomes and survivorship of medial pivot design total knee arthroplasty: a systematic review of the literature.

Author

Alessio-Mazzola M, Clemente A, Russo A, Mertens P, Burastero G, Formica M, and Felli L

Subjects
Follow-Up Studies, Humans, Knee Joint diagnostic imaging, Knee Joint surgery, Prosthesis Design, Range of Motion, Articular, Retrospective Studies, Survivorship, Arthroplasty, Replacement, Knee methods, Knee Prosthesis, Osteoarthritis, Knee diagnostic imaging, Osteoarthritis, Knee surgery
Abstract

Background: Total knee arthroplasty is a reliable procedure able to reduce pain and disability in patients suffering from osteoarthritis. However, a considerable percentage of patients still experiences unsatisfactory results. Medial pivot total knee arthroplasty has been introduced in the clinical practice to overcome problems related with classic design implants and better mimic native knee kinematics. The aim of this study was to analyze survivorship and clinical and radiographic outcomes of medial pivot implants., Methods: A systematic research was conducted in eight different databases. Thirty-four studies met the inclusion criteria and were included in the analysis. Data on objective and patients-reported outcomes, radiographic alignment, and survivorship were collected and analyzed. Revision rate was expressed as revision per 100 components years., Result: A total of 3377 procedures were included. Mean follow-up was 85.7 months (range, 12-182). The revision per 100 components years was 0.19, which corresponds to a revision rate of 1.9% after 10 years. Mean post-operative range of motion was 117.3 ± 0.4°. Mean clinical and functional Knee Society Score were, respectively, 85.9 ± 1.1 and 84.7 ± 3.5 at final follow-up. Post-operative femorotibial alignment was 177.1 ± 0.5°. Alfa and beta angles were 95.7 ± 0.1° and 89.2 ± 0.1°, respectively. Gamma and delta angles were 2.3 ± 0.6° and 86.7 ± 0.4°., Conclusion: Medial pivoting implants provided excellent survivorship and low revision rate, as well as good-to-excellent results in term of objective and patient-reported clinical outcomes, and reliable correction of radiographic parameters. More high-quality studies with long-term follow-up are needed to clarify the role of medial pivoting implants., (© 2021. The Author(s).)

Published
2022
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49. Two-stage revision for periprosthetic joint infection in unicompartmental knee arthroplasty: clinical and radiological results.

Author

Cavagnaro L, Chiarlone F, Mosconi L, Zanirato A, Formica M, and Burastero G

Subjects
Humans, Knee Joint surgery, Reoperation, Retrospective Studies, Treatment Outcome, Arthritis, Infectious surgery, Arthroplasty, Replacement, Knee adverse effects, Arthroplasty, Replacement, Knee methods, Knee Prosthesis adverse effects, Osteoarthritis, Knee surgery, Prosthesis-Related Infections etiology, Prosthesis-Related Infections surgery
Abstract

Introduction: Unicompartmental knee arthroplasty (UKA) has an infection rate of 0.1-0.8%. Despite the wide amount of literature about septic total knee arthroplasty management, few data are available for UKA infection treatment. The aim is to present the clinical and radiological outcomes along with complication rates of a series of septic UKA treated with two-stage exchange., Methods: We retrospectively reviewed 16 patient treated with staged UKA revision for infection between June 2015 and September 2019 in a single bone infection unit. The main demographic and surgical data were recorded. Clinical scores (VAS, KSS, OKS, postoperative ROM), radiological parameters (osseointegration, loosening and radiolucencies) and complications were reported. The mean follow-up was 33.5 ± 6.9 months., Results: Mean age at surgery was 68.5 ± 9.1. All but two were medial UKA. The mean number of previous surgeries was 2.9 ± 1.9. The mean ROM, VAS, KSS and OKS of the entire population improved significantly (p < 0.01). Radiological analysis did not show any migration or implant loosening. Ten constrained condylar and six posterior stabilized prosthesis were finally implanted. One intraoperative pathogen isolation was recorded and managed with suppressive therapy and good final outcome. The implant survivorship free from infection was 100% at the final follow-up. The overall survival rate for any reason of revision was 100% CONCLUSION: According to our results, staged revision represents a reliable ad effective option in delayed and late UKA infections. This technique provides optimal clinical and radiological results with acceptable complication rates. To the best of our knowledge, this represent the widest case series on infected UKA managed with two-stage exchange., (© 2022. The Author(s).)

Published
2022
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50. Predictors of failure of two-stage revision in periprosthetic knee infection: a retrospective cohort study with a minimum two-year follow-up.

Author

Russo A, Cavagnaro L, Chiarlone F, Alessio-Mazzola M, Felli L, and Burastero G

Subjects
Aged, Follow-Up Studies, Humans, Knee Joint surgery, Middle Aged, Reoperation, Retrospective Studies, Treatment Outcome, Arthroplasty, Replacement, Knee adverse effects, Knee Prosthesis adverse effects, Prosthesis-Related Infections surgery
Abstract

Purpose: Despite the standardization of two-stage knee revision protocols, a high percentage of failures still occurs. Identifying the predictors of failure is necessary to determine appropriate management and counsel for patients with a periprosthetic knee infection. This study aimed to identify risk factors predicting the failure, to describe implant survival, and to report the mid-term clinical outcomes of patients undergoing two-stage revision for periprosthetic knee infection., Methods: Data of patients who underwent two-stage knee revision from 2012 to 2016 were analyzed, and 108 patients were included. The mean age was 66.6 ± 9.2 years. The mean follow-up was 52.9 ± 15.6 months. Logistic regression was conducted to identify predictors of treatment failure. Kaplan-Meier curves were generated to assess implant survival. Preoperative functional outcomes were compared to those registered at the final follow-up., Results: Difficult-to-treat infections (OR = 4.2, 95% CI 1.2-14.5, p = 0.025), the number of previous surgeries (OR = 1.8, 95% CI 1.2-2.6, p = 0.005), and the level of tibial bone defect (OR = 2.3, 95% CI 1.1-4.7, p = 0.027) significantly predicted the failure of two-stage knee revision. Survivorship of implants was significantly lower for patients presenting these risk factors (p < 0.05). Mean Knee Society Score improved from 49.0 ± 12.0 to 80.2 ± 13.6 (p < 0.001). Mean Oxford Knee Score improved from 22.2 ± 4.9 to 36.1 ± 6.0 points (p < 0.001)., Conclusion: Difficult-to-treat pathogens, the number of previous surgeries, and the level of tibial bone defect were independent risk factors of two-stage knee revision failure. Overall, the two-stage protocol provided a good survival rate and functional outcome., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2022
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