Outcome and Predictors of Treatment Failure in Chronic Osteomyelitis Using Bioactive Glass Granules and Putty Formulations.

BACKGROUND: The aim of this study is to evaluate the outcome of patients with cavitary chronic osteomyelitis undergoing adjuvant treatment with bioactive glass (BAG) S53P4 and identify the independent risk factors (RFs) for recurrence in 6- and 12-month patient follow-up. METHODS: A retrospective, multicentre observational study conducted in tertiary specialised hospitals among patients undergoing the surgical treatment of chronic cavitary osteomyelitis using BAG-S53P4 in a granule and/or putty formulation to assess the clinical outcome and RFs for failure in 6- and 12-month patient follow-up. RESULTS: Of the 92 and 78 patients with 6-month and 12-month follow-ups, infection was eradicated in 85.9% and 87.2%, respectively. In the 6-month follow-up, BAG-S53P4 in the granule formulation presented a greater risk of recurrence compared to the bioactive glass putty formulation or combined granules and putty (prevalence ratio (PR) = 3.04; confidence interval 95% [CI95%]: 1.13-10.52) and neoplasia (PR = 5.26; CI95%: 1.17-15.52). In the 12-month follow-up cohort of 78 patients, smoking (PR = 4.0; 95% CI: 1.03-15.52) and nonfermenting GNB infection (PR = 3.87; CI95%: 1.09-13.73) presented a greater risk of recurrence. CONCLUSIONS: BAG-S53P4 is a viable option for bone-void filling and the treatment of chronic cavitary osteomyelitis. Formulations of BAG with putty or in combination with granules showed better results.

S53P4 BIOACTIVE GLASS PUTTY IN THE LOCAL TREATMENT OF CAVITARY CHRONIC OSTEOMYELITIS.

Objective: Evaluating the clinical results of bioactive glass S53P4 putty for the treatment of cavitary chronic osteomyelitis. Methods: Retrospective observational study, including patients of any age with clinical and radiological diagnosis of chronic osteomyelitis, who underwent surgical debridement and implantation of bioactive glass S53P4 putty (BonAlive® Putty, Turku, Finland). Patients who underwent any plastic surgery on the soft tissues of the affected site or had segmental bone lesions or septic arthritis were excluded. Statistical analysis was performed using Excel®. Demographic data, as well as data on the lesion, treatment, and follow-up, were collected. Outcomes were classified as "disease-free survival," "failure," or "indefinite." Results: This study included 31 patients, of which 71% were men and had with a mean age of 53.6 years (SD ± 24.2). In total, 84% were followed-up for at least 12 months and 67.7% had comorbidities. We prescribed combination antibiotic therapy for 64.5% of patients. In 47.1%, Staphylococcus aureus was isolated. Finally, we classified 90.3% of cases as "disease-free survival" and 9.7% as "indefinite." Conclusion: Bioactive glass S53P4 putty is safe and effective to treat cavitary chronic osteomyelitis, including infections by resistant pathogens, such as methicillin-resistant S. aureus. Level of Evidence IV, Case Series.

Objetivo: Avaliar a atividade do vidro bioativo S53P4 em pasta no tratamento de osteomielite crônica. Métodos: Estudo observacional retrospectivo, com inclusão de indivíduos de qualquer idade com diagnóstico clínico e radiológico de osteomielite que realizaram tratamento cirúrgico com limpeza e desbridamento, seguido do preenchimento da cavidade com biovidro S53P4 em pasta (BonAlive ® Putty, Turku, Finland). Foram excluídos pacientes submetidos a procedimentos de cirurgia plástica nos tecidos moles do local afetado, com lesões ósseas segmentares e com presença de artrite séptica. A análise estatística foi realizada em Excel ® . Foram coletados dados demográficos, sobre a lesão, o tratamento e o acompanhamento. O desfecho foi classificado em "sobrevida livre de doença", "falha" ou "indeterminado". Resultados: Dos 31 pacientes analisados, 71% eram homens, com idade média de 53,6 anos (DP ± 24,26). Do total, 84% foram acompanhados por no mínimo 12 meses, e 67,7% apresentaram comorbidades. A terapia antibiótica combinada foi realizada em 64,5% dos pacientes, sendo o patógeno mais frequente o Staphylococcus aureus (47,1%). Ao final, 90,3% dos pacientes obtiveram "sobrevida livre de doenças" e 9,7% foram considerados "indeterminados". Conclusão: O vidro bioativo S53P4 em pasta é seguro e eficaz no tratamento da osteomielite cavitária e de infecções por patógenos resistentes, incluindo o S. aureus multirresistente. Nível de Evidência IV, Série de Casos.

S53p4 bioactive glass putty in the local treatment of cavitary chronic osteomyelitis / Biovidro ativo s53p4 em pasta no tratamento local da osteomielite crônica cavitária

ABSTRACT Objective: Evaluating the clinical results of bioactive glass S53P4 putty for the treatment of cavitary chronic osteomyelitis. Methods: Retrospective observational study, including patients of any age with clinical and radiological diagnosis of chronic osteomyelitis, who underwent surgical debridement and implantation of bioactive glass S53P4 putty (BonAlive® Putty, Turku, Finland). Patients who underwent any plastic surgery on the soft tissues of the affected site or had segmental bone lesions or septic arthritis were excluded. Statistical analysis was performed using Excel®. Demographic data, as well as data on the lesion, treatment, and follow-up, were collected. Outcomes were classified as "disease-free survival," "failure," or "indefinite." Results: This study included 31 patients, of which 71% were men and had with a mean age of 53.6 years (SD ± 24.2). In total, 84% were followed-up for at least 12 months and 67.7% had comorbidities. We prescribed combination antibiotic therapy for 64.5% of patients. In 47.1%, Staphylococcus aureus was isolated. Finally, we classified 90.3% of cases as "disease-free survival" and 9.7% as "indefinite." Conclusion: Bioactive glass S53P4 putty is safe and effective to treat cavitary chronic osteomyelitis, including infections by resistant pathogens, such as methicillin-resistant S. aureus. Level of Evidence IV, Case Series.

RESUMO Objetivo: Avaliar a atividade do vidro bioativo S53P4 em pasta no tratamento de osteomielite crônica. Métodos: Estudo observacional retrospectivo, com inclusão de indivíduos de qualquer idade com diagnóstico clínico e radiológico de osteomielite que realizaram tratamento cirúrgico com limpeza e desbridamento, seguido do preenchimento da cavidade com biovidro S53P4 em pasta (BonAlive ® Putty, Turku, Finland). Foram excluídos pacientes submetidos a procedimentos de cirurgia plástica nos tecidos moles do local afetado, com lesões ósseas segmentares e com presença de artrite séptica. A análise estatística foi realizada em Excel ® . Foram coletados dados demográficos, sobre a lesão, o tratamento e o acompanhamento. O desfecho foi classificado em "sobrevida livre de doença", "falha" ou "indeterminado". Resultados: Dos 31 pacientes analisados, 71% eram homens, com idade média de 53,6 anos (DP ± 24,26). Do total, 84% foram acompanhados por no mínimo 12 meses, e 67,7% apresentaram comorbidades. A terapia antibiótica combinada foi realizada em 64,5% dos pacientes, sendo o patógeno mais frequente o Staphylococcus aureus (47,1%). Ao final, 90,3% dos pacientes obtiveram "sobrevida livre de doenças" e 9,7% foram considerados "indeterminados". Conclusão: O vidro bioativo S53P4 em pasta é seguro e eficaz no tratamento da osteomielite cavitária e de infecções por patógenos resistentes, incluindo o S. aureus multirresistente. Nível de Evidência IV, Série de Casos.