Randomized Controlled Trials in orthopedics and traumatology: systematic analysis of the national evidence

OBJECTIVE: To assess whether there was an improvement in the quality and quantity of randomized controlled trials (RCTs) in nationally published journals through an application of standardized and validated scores. METHODS: We selected, electronically, for the period of 2000-2009, all RCTs published at the two indexed, orthopaedics-focused Brazilian journals: Acta Ortopédica Brasileira(AOB) and Revista Brasileira de Ortopedia (RBO). These RCTs were identified and scored by two independent researchers according to the JADAD scale and Cochrane Bone, Joint and Muscle Trauma Group score. The selected studies were grouped: 1) by publication period (2000-2004 and 2004-2009); 2) journal of publication (AOB and RBO). RESULTS: Twenty-two papers were selected, 10 from AOB and 12 from RBO. No statistically significant differences were found between the proportion (nRCT/nTotal of published papers) of RCTs published in the two journals (p=0.458), as well as for the JADAD score (p=0.722) and Cochrane score (p=0.630). CONCLUSION: The quality and quantity of randomized clinical trials in the period was similar in the journals analyzed. There is a trend of improvement of quality, yet there was no increase in the number of randomized clinical trials in both periods.OBJETIVO: Verificar se houve melhora da qualidade e quantidade dos ensaios clínicos randomizados (ECRs) publicados na literatura nacional, por meio da aplicação de escores estruturados e validados na literatura. MÉTODOS: Selecionamos, eletronicamente, todas as edições das duas revistas indexadas e de escopo ortopédico da literatura nacional - Acta Ortopédica Brasileira (AOB) e Revista Brasileira de Ortopedia (RBO), no período de 2000-2009, todos os ECRs publicados. Dois pesquisadores independentes identificaram e pontuaram os ECRs de acordo com as escalas de JADAD e do grupo de trauma musculoesquelético da Colaboração Cochrane. Os trabalhos selecionados foram agrupados: 1) pelo período de publicação 2000-2004 e 2004-2009; 2) periódico de publicação (AOB e RBO). RESULTADOS: Vinte e dois trabalhos foram selecionados, sendo10 da AOB e 12 da RBO. Não houve diferença entre o número proporcional (nECR/nTotal de trabalhos publicados) de ensaios clínicos randomizados publicados nos dois periódicos (p = 0,458), assim como para os escores de JADAD (p = 0,722) e da Colaboração Cochrane (p = 0,630). CONCLUSÃO: A qualidade e quantidade relativa de ensaios clínicos randomizados nos periódicos analisados foi semelhante. Há uma tendência de melhora da qualidade; contudo, não há acréscimo da quantidade de ensaios clínicos randomizados nos dois períodos analisados.Universidade Federal de São Paulo (UNIFESP) Departamento de Ortopedia e TraumatologiaUniversidade Federal de São Paulo (UNIFESP) Departamento de Ortopedia e Traumatologia Setor de Ombro e Cotovelo da Disciplina de Mão e Membro SuperiorUNIFESP, Depto. de Ortopedia e TraumatologiaUNIFESP, Depto. de Ortopedia e Traumatologia Setor de Ombro e Cotovelo da Disciplina de Mão e Membro SuperiorSciEL

Surgical Interventions for the Treatment of Supracondylar Humerus Fractures in Children: Protocol of a Systematic Review

Background: The treatment of supracondylar humerus fracture in children (SHFC) is associated with complications such as functional deficit, residual deformity, and iatrogenic neurological damage. The standard treatment is closed reduction and percutaneous Kirschner wire fixation with different configurations. Despite this fact, there is still no consensus on the most effective technique for the treatment of these fractures. Objective: The aim of this systematic review will be to evaluate the effect of surgical interventions on the treatment of Gartland type II and III SHFC by assessing function, complications, and error as primary outcomes. Clinical outcomes such as range of motion and pain and radiographic outcomes will also be judged. Methods: A systematic review of randomized controlled trials or quasi-randomized controlled trials evaluating the surgical treatment of SHFC will be carried out in the Cochrane Central Register of Controlled Trials, PubMed, Literatura Latino-Americana e do Caribe em Ciencias da Saude, and Excerpta Medica Database. The search will also occur at ongoing and recently completed clinical trials in selected databases. Data management and extraction will be performed using a data withdrawal form and by analyzing the following: study method characteristics, participant characteristics, intervention characteristics, results, methodological domains, and risk of bias. To assess the risk of bias of the included trials, the Cochrane Risk of Bias Tool will be used. Dichotomous outcome data will be analyzed as risk ratios, and continuous outcome data will be expressed as mean differences, both with 95% confidence intervals. Also, whenever possible, subgroup analysis, sensitivity analysis, and assessment of heterogeneity will be performed. Results: Following the publication of this protocol, searches will be run and included studies will be deeply analyzed. We hope to obtain final results in the next few months and have the final paper published by the end of 2018. This study was funded by a government-based noncommercial agency, Fundacao de Amparo a Pesquisa do Estado de Sao Paulo (FAPESP). Conclusions: This study may provide surgical treatment effects evidence for SHFC. The results will assist clinical practice by demonstrating the effectiveness and potential complications of these interventions and might serve as a reference for future clinical trials on the topic.Fundacao de Amparo a Pesquisa do Estado de Sao Paulo (FAPESP)Univ Fed Sao Paulo, Escola Paulista Med, Dept Orthoped & Traumatol, Rua Borges Lagoa 783-5o, Sao Paulo, BrazilUniv Fed Sao Paulo, Escola Paulista Med, Dept Orthoped & Traumatol, Rua Borges Lagoa 783-5o, Sao Paulo, BrazilWeb of Scienc

Surgical versus conservative inverventions for treating acromioclavicular dislocation of the shoulder in adults

Introdução: As luxações acromioclaviculares são afecções do ombro comuns na traumatologia ortopédica. Ainda hoje existe controvérsia sobre o método de tratamento mais efetivo. Objetivo: Avaliar a efetividade das intervenções cirúrgicas comparadas às não cirúrgicas para o tratamento das luxações acromioclaviculares agudas em adultos. Métodos: Foi realizada busca no Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (até fevereiro de 2009), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, Issue 1), MEDLINE (1966 até fevereiro de 2009), EMBASE (1988 até fevereiro de 2009), e LILACS (1982 até fevereiro de 2009). Além disso, foi pesquisada em registros e ensaios clínicos e realizada busca manual de artigos. Não houve restrição quanto à língua ou status de publicação. Foram incluídos estudos randomizados e quase-randomizados que compararam quaisquer técnicas cirúrgicas às não cirúrgicas para o tratamento das luxações acromioclaviculares agudas. Resultados: Três estudos foram incluídos com total de 174 participantes. Dois estudos eram randomizados e um quaserandomizado. Nenhum utilizou instrumentos validados para aferição dos resultados, embora todos relataram maior número de complicações como quebra e migração de implantes no grupo cirúrgico, que também está relacionada ao maior tempo de retorno às atividades prévias. Conclusão: não há evidência suficiente para determinar quando o tratamento cirúrgico está indicado para as luxações acromioclaviculares agudas em adultos. Ensaios com boa qualidade metodológica, amostra adequada, descrição dos resultados por instrumentos validados, comparando métodos cirúrgicos atuais são necessários para definir esta questão. Contudo o tratamento cirúrgico está relacionado a um maior número de complicações e a um maior tempo de retorno às atividades prévias.Background: Dislocation of the acromioclavicular joint is one of the most common shoulder problems in general orthopaedic practice. The question of whether surgery should be used remains controversial.Objective To assess the relative effects of surgical versus conservative (non-surgical) interventions for treating acromioclavicular dislocations in adults. Method: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to February 2009), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2009, Issue 1), MEDLINE (1966 to February 2009), EMBASE (1988 to February 2009), and LILACS (1982 to February 2009), trial registries and reference lists of articles. There were no restrictions based on language or publication status. All randomised and quasi-randomised trials that compared surgical with conservative treatment of acromioclavicular dislocation in adults were included. Main results Three trials were included in this review. These involved a total of 174 mainly male participants. Two trials were randomised and one was quasirandomised. None used validated measures for assessing functional outcome. Authors' conclusions There is insufficient evidence from randomised controlled trials to determine when surgical treatment is indicated for acromioclavicular dislocation in adults in current practice. Sufficiently powered, good quality, well-reported randomised trials of currently-used surgical interventions versus conservative treatment for well-defined injuries are required. All three trials, however, reported complications from the breakage and migration of implants used for primary fixation across the acromioclavicular joint that sometimes required a further operation additional to the routine surgery needed for implant removal. Surgery was also associated with a longer time off from work and other activities