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

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

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

Total knee arthroplasty with subvastus approach in patient with chronic post-traumatic patellar dislocation

AbstractChronic lateral dislocation of the patella is a rare condition and acquired causes are usually secondary to knee trauma. The neglected chronic dislocation leads to progressive genu valgum and external tibial torsion deformities with subsequent gonarthrosis, which becomes painful and debilitating. There is no consensus regarding treatment of these patients, but total knee arthroplasty (TKA) is a useful therapy in cases of painful symptomatic gonarthrosis. Few reports have shown that subvastus approach and lateral release may be a valid option for TKA, since it allows the correction of valgus deformity and patellar tracking without interrupting vascular blood supply of patella. This article reports a case of TKA and extensor mechanism realignment without patellar resurfacing in a patient with genu valgum and chronic post-traumatic patellar dislocation with satisfactory results after two years of follow-up

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

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

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

Patellar Tendon Healing With Platelet-Rich Plasma A Prospective Randomized Controlled Trial

Background: The patellar tendon has limited ability to heal after harvesting its central third. Platelet-rich plasma (PRP) could improve patellar tendon healing. Hypothesis: Adding PRP to the patellar tendon harvest site would improve donor site healing and improve clinical outcome at 6 months after anterior cruciate ligament (ACL) reconstruction with a patellar tendon graft. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Twenty-seven patients were randomly divided to receive (n = 12) or not receive (n = 15) PRP in the patellar tendon harvest site during ACL reconstruction. The primary outcome was magnetic resonance imaging (MRI) assessment of patellar tendon healing (gap area) after 6 months. Secondary outcomes were questionnaires and isokinetic testing of ACL reconstruction with a patellar tendon graft comparing both groups. Results: Patellar tendon gap area was significantly smaller in the PRP group (4.9 +/- 5.3 mm(2); 95% confidence interval [CI], 1.1-8.8) than in the control group (9.4 +/- 4.4 mm(2); 95% CI, 6.6-12.2; P = .046). Visual analog scale score for pain was lower in the PRP group immediately postoperatively (3.8 +/- 1.0; 95% CI, 3.18-4.49) than in the control group (5.1 +/- 1.4; 95% CI, 4.24-5.90; P = .02). There were no differences after 6 months in questionnaire and isokinetic testing results comparing both groups. Conclusion: We showed that PRP had a positive effect on patellar tendon harvest site healing on MRI after 6 months and also reduced pain in the immediate postoperative period. Questionnaire and isokinetic testing results were not different between the groups at 6 months