Randomized controlled clinical trials in orthopedics: difficulties and limitations

Os ensaios clínicos controlados e randomizados (ECCR) são considerados o padrão ouro da medicina baseada em evidências na atualidade, sendo importantes para direcionar a conduta médica através de observações científicas consistentes. Passos como seleção dos pacientes, randomização e cegamento são fundamentais na realização de um ECCR e apresentam algumas dificuldades extras nos ensaios que envolvem procedimentos cirúrgicos, como é comum na Ortopedia. O objetivo deste artigo é destacar e discutir algumas dificuldades e eventuais limitações dos ECCR na área cirúrgica.Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting an RCT, but some additional difficulties are presented in trials that involve surgical procedures, as in common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery

Limits to clinical trials in surgical areas

Randomized clinical trials are considered to be the gold standard of evidence‐based medicine nowadays. However, it is important that we point out some limitations of randomized clinical trials relating to surgical interventions. There are limitations that affect the external and internal validity of many surgical study designs. Some limitations can be bypassed, but can make it more difficult for the study to be carried out. Other limitations cannot be bypassed. When it is intended to extrapolate the result of a randomized clinical trial, the premise is that the performed or to be performed intervention will be similar wherever applied and/or for every doctor using it. However, no matter how standardized the technique may be, the results are not similar for all surgeons, which implies a significant limitation to surgical randomized clinical trials concerning external validity. When considering the various limitations presented for performing surgical trials capable of generating scientific evidence within the patterns currently proposed in the evidence level classifications of medical publications, it is necessary to rethink whether those scientific evidence levels are similarly applicable to surgical works and to nonsurgical trials. We currently live in a time of supposed “inferiority” of surgical scientific works under the optics of the current quality criteria for a “suitable” clinical trial

Autologous chondrocyte implantation: series of 3 cases

A cartilagem hialina recobre as superfícies articulares e tem um papel importante na redução da fricção e da carga mecânica das articulações sinoviais, como o joelho. Este tecido não é suprido de vasos, nervos ou circulação linfática, o que pode ser uma das razões pela qual a cartilagem articular tem uma péssima capacidade de cicatrização. As lesões condrais, quando atingem o osso subcondral (lesão osteocondral), não cicatrizam e podem progredir para artrose com o passar do tempo. Em pacientes jovens, o tratamento dos defeitos condrais do joelho ainda é um desafio, principalmente as lesões maiores de 4cm. Uma das opções de tratamento nesses pacientes é o transplante autólogo de condrócitos, que por não violar o osso subcondral e por reparar o defeito com tecido semelhante à cartilagem hialina, teria a vantagem teórica de ser mais biológico e mecanicamente superior, quando comparado a outras técnicas. Descreveremos nesse artigo a experiência do Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo (IOT-HCFMUSP) com o transplante autólogo de condrócitos (ACI), através do relato de três casos.Hyaline cartilage in the surface of synovial joints plays an important role in lowering stress and attrition in joints such as the knee. This tissue has no blood vessels, nerves, nor lymphatic drainage, which in part explains why articular cartilage has such poor capacity for healing. Chondral lesions reaching the subchondral bone (osteochondral lesions) do not heal and may progress to osteoarthritis as time passes. In young patients, treatment of such defects is challenging, especially in lesions larger than 4 cm. One option in young adults is the autologous chondrocyte implantation, capable of filling the defect with tissue similar to hyaline cartilage without violating the subchondral bone. Theoretically, it has biological and mechanical advantages over other surgical options. In this paper, we describe the experience with this procedure in a series of 3 cases at the Institute of Orthopedics and Traumatology, University of São Paulo

Use of fresh osteochondral transplants for treating osteochondral knee lesions

O tratamento das lesões condrais e osteocondrais do joelho em pacientes jovens ainda permanece um desafio para os ortopedistas. As técnicas de reparo atualmente disponíveis no Brasil, como o desbridamento, microfraturas e transplante osteocondral autólogo são insuficientes nos tratamentos de lesões condrais e osteocondrais grandes. O transplante osteocondral homólogo a fresco (TOF) na articulação do joelho vem sendo usado nos Estados Unidos com excelentes resultados. Este artigo tem o intuito de revisar a ciência básica, indicações, técnicas cirúrgicas, possíveis complicações e descrever a técnica de transplante osteocondral homólogo a fresco na articulação do joelho realizada no Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo

Use of allograft in ligamentar reconstruction of knee

INTRODUÇÃO: A utilização de enxerto alógeno é um tema que há décadas desperta interesse dos ortopedistas devido às supostas vantagens que apresenta, como diminuição do tempo cirúrgico, maior tamanho de enxerto, ausência de morbidade do sítio doador. OBJETIVO: O artigo a seguir faz análise retrospectiva da casuística do grupo de joelho do IOT-HC-FMUSP no uso de enxerto de banco de tecido próprio para reconstruções ligamentares. Serão apresentados as indicações de uso de enxerto alógeno e qual tipo de enxerto foi utilizado para cada tipo de reconstrução ligamentar. MÉTODOS: Foram revisados prontuários de 46 pacientes. RESULTADOS: Usados como enxerto 30 unidades de tendão patelar, 09 unidades de tendão tibial anterior, 08 unidades de tendão calcâneo, 06 unidades de tendão quadriceptal e 01 unidade de tendão fibular e foram usados principalmente para reconstruções multi-ligamentares e revisões de reconstrução do ligamento cruzado anterior. CONCLUSÃO: O uso de enxerto alógeno mostrou-se uma interessante opção para as recosntruções ligamentares.INTRODUCTION: The use of allograft is a matter of huge interest for orthopaedic surgeons, due to the supposed advantages with its use, like decreased surgical time, larger grafts and no donator site morbidity. OBJECTIVES: The aim of this article was to review our experience with the use of allografts on ligament reconstruction. We present the technique applied for graft harvest, preparation and storage, as well as the indications for allograft use and the type of procedure in which it was applied. METHODS: We revised the records of 46 patients. RESULTS: We used 09 patellar tendons, 09 anterior tibial tendons, 08 calcaneal tendons, 06 quadriceptal tendons and 01 fibular tendon, mainly for multiple ligamentar reconstructions and ACL reviews. CONCLUSION: The use of allograft seems to be an interesting option for ligamentar reconstruction

An Unusual Metallic Foreign Body inside the Knee Medial Femoral Condyle

Foreign bodies in the knee joint are uncommon, particularly those not related to surgical procedures. In this paper, we present a case of an intraosseous metallic foreign body situated in the medial femoral condyle for one year, causing pain, which was removed with complete resolution of the symptoms

Comparison of Floseals and Tranexamic Acid for Bleeding Control after Total Knee Arthroplasty: a Prospective Randomized Study

OBJECTIVE: Tranexamic acid (TXA) and the hemostatic agent Floseals have already been used to minimize bleeding during total knee arthroplasty (TKA). METHODS: We conducted a prospective, randomized study of 90 patients with indications for TKA. Following inclusion, the participants were randomly allocated in blocks to the following 3 groups: control, Floseals and TXA. Bleeding parameters, including decreases in hemoglobin (Hb), drain output, number of blood transfusions and complications, were assessed. ClinicalTrials.gov: NCT02152917. RESULTS: The mean decrease in Hb was highest in the control group (4.81±1.09 g/dL), followed by the Floseals (3.5±1.03 g/dL) and TXA (3.03±1.2 g/dL) groups. The Floseals and TXA groups did not differ, and both performed better than the control group. The mean total drain output was 901.3±695.7 mL in the control group, 546.5±543.5 mL in the TXA group and 331.2±278.7 mL in the Floseals group. Both TXA and Floseals had significantly less output than the control group, and Floseals had significantly less output than TXA. The number of blood transfusions was very small in all 3 groups. CONCLUSION: The use of TXA or Floseals was associated with less blood loss than that of the control group among patients undergoing primary TKA, as measured both directly (intraoperative bleeding + drainage) and on the basis of a decrease in Hb, without differences in the rate of complications. TXA and Floseals showed similar decreases in Hb and total measured blood loss, but the drain output was smaller in the Floseals group

Study on implant stability in cementless total knee arthroplasty

OBJETIVO: Comparar dois métodos de avaliação da estabilidade dos componentes tibial e femoral nas artroplastias de joelho não cimentadas com plataforma rotatória. MÉTODOS: Para isso foram avaliados 20 pacientes (20 joelhos) através de uma análise de radiografias dinâmicas com intensificador de imagem e manobras de estresse em varo e valgo, que foram comparadas com radiografias estáticas em frente e perfil dos joelhos, analisadas por dois cirurgiões experientes, cegos um em relação ao outro. RESULTADOS: Os resultados das análises estáticas e dinâmicas foram comparados e demonstraram forte correlação estatística (p<0,001), utilizando-se o método Kappa de comparação. CONCLUSÃO: O componente tibial mostrou-se mais instável quando comparado com o componente femoral, tanto na análise estática, quanto na dinâmica. Nível de evidência IV, Série de Casos

Septic arthritis of the knee: clinical and laboratory comparison of groups with different etiologies

OBJECTIVES: To clinically and epidemiologically characterize a population diagnosed with and treated for septic arthritis of the knee, to evaluate the treatment results and to analyze the differences between patients with positive and negative culture results, patients with Gram-positive and Gram-negative bacterial isolates and patients with S. aureus- and non-S. aureus-related infections. METHODS: One hundred and five patients with septic knee arthritis were included in this study. The clinical and epidemiological data were evaluated. Statistical analysis was performed to compare patients with and without an isolated causative agent, patients with Gram-positive and Gram-negative pathogens and patients with S. aureus-related and non S. aureus-related infections. RESULTS: Causative agents were isolated in 81 patients. Gram-positive bacteria were isolated in 65 patients and Gram-negative bacteria were isolated in 16 patients. The most commonly isolated bacterium was S. aureus. Comparing cases with an isolated pathogen to cases without an isolated pathogen, no differences between the studied variables were found except for the longer hospital stays of patients in whom an etiological agent was identified. When comparing Gram-positive bacteria with Gram-negative bacteria, patients with Gram-positive-related infections exhibited higher leukocyte counts. Patients with S. aureus-related infections were more frequently associated with healthcare-related environmental encounters. CONCLUSION: S. aureus is the most common pathogen of septic knee arthritis. Major differences were not observed between infections with isolated and non-isolated pathogens and between infections with Gram-positive and Gram-negative bacteria. S. aureus infections were more likely to be associated with a prior healthcare environment exposure