The relevance of trial quality to find the best evidence

The search for scientific knowledge has been more and more guided by methodological principles whose objective is to provide guidelines for the execution and later analysis of the results achieved. The standardization of this method is being more and more debated and evaluated, thus contributing to improved quality of published trials. The purpose of this article is to present the guidelines suggested by international groups to authors and publishers who critically evaluate controlled and randomized clinical trials.A busca do conhecimento científico cada vez mais tem sido norteada por orientações metodológicas que têm por objetivo fornecer diretrizes para a execução e posterior análise dos resultados obtidos. A padronização desta metodologia está sendo cada vez mais discutida e avaliada, contribuindo para a melhora da qualidade dos estudos publicados. Este artigo tem por objetivo apresentar essas diretrizes, sugeridas por grupos internacionais para autores e editores que orientam a avaliação critica de ensaios clínicos controlados e randomizados.Universidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Departamento de Ortopedia e TraumatologiaUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Departamento de MedicinaUNIFESP, EPM, Depto. de Ortopedia e TraumatologiaUNIFESP, EPM, Depto. de MedicinaSciEL

Treatment of pelvic and acetabular fractures through modified Stoppa port

This study describes the modified Stoppa access port for treating fractures on pelvic anterior region and fractures affecting the acetabulum anterior column. In this access port, a suprapubic cross-sectioned incision is performed on skin, longitudinal opening of the abdominal rectus muscle with lateral displacement of venters, and subperiosteal bone dissection through the medial surface of the hemipelvis addressed, so that implant materials can be placed on that inner surface. This access port, little used in our area, presents advantages over the traditional ports, such as the ilioinguinal and iliofemoral, due to the potential for a smaller surgical wound and soft parts dissection, enabling implants to be placed directly on quadrilateral layer, achieving a stable fixation and reducing the risks of infection and injuries to neurovascular structures. As a result of current literature and of the experience of the authors with the use of that access port, we can conclude that it is a good alternative for accessing those fractures.Este estudo descreve a via de acesso de Stoppa modificada no tratamento das fraturas da região anterior da pelve e das fraturas que acometem a coluna anterior do acetábulo. Nesta via de acesso é realizada uma incisão transversal suprapúbica na pele, abertura longitudinal do músculo reto abdominal com afastamento de seus ventres lateralmente e dissecção óssea subperiosteal pela face medial da hemipelve abordada, sendo que os materiais de implante podem então ser colocados nesta face interna. Esta via de acesso, pouco difundida em nosso meio, apresenta vantagens diante das tradicionais ilioinguinal e iliofemoral, pois é realizada menor incisão cirúrgica e dissecção de partes moles, possibilita a colocação de implantes diretamente na lâmina quadrilátera, obtém uma fixação estável e diminui os riscos de infecção e lesão de estruturas neurovasculares. Diante da literatura atual e da experiência adquirida pelos autores com o uso desta via de acesso, conclui-se que é uma boa alternativa para o acesso a estas fraturas.Universidade Federal de São Paulo (UNIFESP) Departamento de OrtopediaHospital Felício RochoUNIFESP, Depto. de OrtopediaSciEL

Use of blocked intramedullary shaft for the treatment of humeral diaphyseal fractures

Clinical and radiographic outcomes of 31 patients with humeral diaphyseal fractures submitted to surgery with intramedullary shafts were studied. From these, four patients presented fractures at the shaft insertion site and were treated using a different method. From the 27 patients left, the healing rate was 96.1%, with an average duration of 63.4 days. Five of them complained of pain in the shoulder and only one presented abduction limitation. Temporary palsy of the radial nerve was found in two patients and pseudoarthrosis in one of them, who was submitted to a new surgical intervention with plate and autologous bone graft, after 5 months. It was concluded that, although blocked intramedullary shafts presents a high incidence of the retrograde access port leading to fractures in its insertion site and the anterograde port causing pain in the shoulder.Estudamos os resultados clínicos e radiográficos de 31 pacientes portadores de fraturas diafisárias do úmero que foram operados com hastes intramedulares. Destes quatro apresentaram fraturas no local da inserção da haste e foram tratados com outro método. Dos 27 pacientes restantes o índice de consolidação foi de 96,1 % e que durou em média de 63,4 dias. Cinco queixaram-se de dor no ombro e em apenas um apresentou limitação da abdução. Paralisia temporária do nervo radial foi constatada em dois pacientes e pseudartrose em um que após 5 meses da cirurgia foi submetido a nova intervenção cirúrgica com o emprego de placa e enxerto ósseo autólogo. Concluímos que embora o emprego de hastes intramedulares bloqueadas apresentou alto índice de a via de acesso retrógrada pode levar a fraturas no seu ponto de entrada e via anterógrada com violação do manguito rotador pode gerar dores no ombro.Universidade Federal de São Paulo (UNIFESP) Departamento de Ortopedia e TraumatologiaUniversidade de São Paulo Faculdade de MedicinaUNIFESP, Depto. de Ortopedia e TraumatologiaSciEL

The role of bone morphogenetic protein on bone tissue repair

This literature review study addresses the progresses of the use of the bone morphogenetic protein (BMP) for repairing the bone tissue and its mechanisms of action in the injured tissue. The BMPs are pleiotropic molecules that are involved in the chemotaxis, mitosis and differentiation of mesenchymal cells in the bone tissue.Este estudo de revisão da literatura aborda os avanços do uso da proteína morfogenética óssea (BMP) na reparação do tecido ósseo e seus mecanismos de ação no tecido lesionado. As BMPs são moléculas pleiotrópicas que são envolvidas na quimiotaxia, mitose e diferenciação de células mesenquimais no tecido ósseo.Universidade Federal de São Paulo (UNIFESP) Departamento de PatologiaUniversidade Federal de São Paulo (UNIFESP) Departamento de Ortopedia e TraumatologiaUNIFESP, Depto. de PatologiaUNIFESP, Depto. de Ortopedia e TraumatologiaSciEL

Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol

Background: Various treatments are available for reducible unstable fractures of the distal radius, such as closed reduction combined with fixation by external fixator (EF), and rigid internal fixation using a locked volar plate (VP). Although there are studies comparing these methods, there is no conclusive evidence indicating which treatment is best. the hypothesis of this study is that surgical treatment with a VP is more effective than EF from the standpoint of functional outcome (patient-reported).Methods/Design: the study is randomized clinical trial with parallel groups and a blinded evaluator and involves the surgical interventions EF and VP. Patients will be randomly assigned (assignment ratio 1: 1) using sealed opaque envelopes. This trial will include consecutive adult patients with an acute (up to 15 days) displaced, unstable fracture of the distal end of the radius of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft fur Osteosynthesefragen-Association for the Study of Internal Fixation classification and type II or type III by the IDEAL(32) classification, without previous surgical treatments of the wrist. the surgical intervention assigned will be performed by three surgical specialists familiar with the techniques described. Evaluations will be performed at 2, and 8 weeks, 3, 6 and 12 months, with the primary outcomes being measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and measurement of pain (Visual Analog Pain Scale and digital algometer). Secondary outcomes will include radiographic parameters, objective functional evaluation (goniometry and dynamometry), and the rate of complications and method failure according to the intention-to-treat principle. Final postoperative evaluations (6 and 12 months) will be performed by independent blinded evaluators. for the Student's t-test, a difference of 10 points in the DASH score, with a 95% confidence interval, a statistical power of 80%, and 20% sampling error results in 36 patients per group.Discussion: Results from this study protocol will improve the current evidence regarding to the surgical treatment these fractures.Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)Universidade Federal de São Paulo, UNIFESP EPM, Dept Orthoped & Traumatol, Hand Arm & Shoulder Surg Unit, São Paulo, BrazilHand Arm & Shoulder Surg Unit, São Paulo, BrazilUniversidade Federal de São Paulo, UNIFESP EPM, Dept Orthoped & Traumatol, Hand Arm & Shoulder Surg Unit, São Paulo, BrazilFAPESP: FAPESP - 2012/00806-2- annex 3Web of Scienc

Effect of shock waves upon the growth plate in rabbits

OBJECTIVE: To evaluate the effects of shock waves upon the growth plate in rabbits by varying the energy and number of applied waves. MATERIAL AND METHODS: Six groups of five rabbits aged 5 weeks (Total: 30) were studied. OSSATRON (HMT) was used to generate shock waves. Animals were submitted to applications upon the proximal growth plate of the left tibia; the intensity (14, 21,28kV) and number of waves varied (1,000 and 4,000). The right tibia was used as control. Animals were sacrificed after six weeks when measurements of tibia length were taken and the growth plate was microscopically studied. Statistical tests were used to compare measurements of the growth plate area and tibia length with those obtained in the control group, as well as between study groups. RESULTS: In the present study, no statistically significant change was found in the measurements of the growth plate area and tibia length following application of shock waves in either group. A difference in the tibia growth tended to occur between the groups submitted to 1,000 impulses and the groups submitted to 4,000 impulses. However, this difference was not statistically significant. Hematomas were seen in the local of application in groups submitted to higher-energy waves and spontaneously subsided, special care being not required. CONCLUSIONS: The application of shock waves upon the proximal tibia in immature rabbits as described did not have any effect upon the growth plate, as shown by the evaluation methods used in the present study.OBJETIVO: Avaliar os efeitos da aplicação de ondas de choque na placa de crescimento de coelhos, variando a energia e o número de ondas aplicadas. MATERIAL E MÉTODOS: Foram estudados 30 coelhos com idade de cinco semanas divididos em seis grupos. O aparelho gerador de ondas de choque foi o OSSATRON (HMT). Os animais foram submetidos a aplicações na placa de crescimento proximal da tíbia esquerda, variando a intensidade (14, 21,28kV) e o número de ondas (1000 e 4000). A tíbia direita foi usada como controle. Os animais foram sacrificados após seis semanas e sua avaliação foi feita por meio da mensuração do comprimento das tíbias e pela análise microscópica da placa de crescimento. Os resultados de mensuração da área da placa e do comprimento das tíbias foram comparados com o grupo controle e entre os grupos, utilizando-se estudos estatísticos. RESULTADOS: Neste estudo não ocorreram alterações estatisticamente significantes nas medidas da área da placa ou do comprimento da tíbia após a aplicação de ondas de choque em nenhum dos grupos. Foi observada tendência de ocorrer uma diferença de crescimento das tíbias entre os grupos submetidos a 1.000 impulsos e os grupos submetidos a 4.000 impulsos, mas esta diferença não foi considerada significante. Foi observada também a formação de hematoma no local da aplicação nos grupos que receberam ondas com maior energia, evoluindo com regressão espontânea sem necessidade de cuidados especiais. CONCLUSÕES: A aplicação de ondas de choque na região proximal da tíbia de coelhos imaturos, nas formas descritas, não teve nenhum efeito na placa de crescimento, de acordo com os métodos de avaliação usados neste estudo.Universidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Departamento de Ortopedia e TraumatologiaUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Departamento de PatologiaUNIFESP, EPM, Depto. de Ortopedia e TraumatologiaUNIFESP, EPM, Depto. de PatologiaSciEL

Fibroblasts growth factor and nerve fragments effect on tibial nerve regeneration in rats: a comparative study

OBJECTIVE: To quantitatively compare rats' tibial nerve regeneration stimulation by Fibroblast Growth Factor (FGF) and nerve fragments using silicone tubes. METHODS: 18 Wistar rats were employed in this experiment. The experimental surgery consisted of resection of an 8-mm tibial nerve segment, followed by an interposition of silicone tubes. On the right side, the tube was filled with a Fibroblast Growth Factor (FGF) solution, and on the left side, it was filled with 1 mm nerve segments. After three months, the animals were submitted to an additional surgery for exposing tibial nerves to the neuronal marker Fluoro-Gold®. After 48 hours, they were perfused with a paraformaldehyde solution and the medullar segment between L3 and S1 was removed and cut into 40 mum-thick segments. RESULTS AND CONCLUSION: The results of neuronal counts showed a higher amount of neurons on the side where FGF was used compared to the side where nervous fragments were placed, suggesting a superior performance of the fibroblast growth factor over nerve fragments for stimulating nervous regeneration in silicone tubes.OBJETIVO: Comparar quantitativamente, a estimulação da regeneração do nervo tibial de ratos pelo Fator de Crescimento de Fibroblastos e por fragmentos de nervo dentro tubos de silicone. MÉTODOS: Foram utilizados 18 ratos da raça Wistar. A cirurgia consistiu inicialmente na ressecção de um segmento de 8 mm do nervo tibial, seguida da interposição com tubos de silicone. No lado direito, o tubo foi preenchido com solução de Fator de Crescimento de Fibroblastos (FGF) e, no lado esquerdo, com segmentos do nervo cortados em fragmentos de 1 mm. Após três meses, os animais foram submetidos a nova cirurgia para exposição dos nervos tibiais ao marcador neuronal Fluro-Gold®. Quarenta e oito horas após a exposição ao corante, os ratos foram perfundidos com solução de paraformaldeído e o segmento medular entre L3 e S1 foi removido e cortado em fatias de 40 micrômetros de espessura. RESULTADOS E CONCLUSÃO: os resultados da contagem neuronal mostraram maior quantidade de neurônios no lado onde foi colocado FGF em relação ao lado onde foram colocados fragmentos nervosos, demonstrando que o fator de crescimento de fibroblastos é superior a fragmentos de nervos na estimulação da regeneração nervosa quando colocados no tubo de silicone.UNIFESPUNIFESP Departamento de Ortopedia e TraumatologiaUNIFESP, Depto. de Ortopedia e TraumatologiaSciEL

Efetividade da injeção intrarticular de lidocaína na redução das luxações anteriores do ombro: ensaio clínico randomizado

CONTEXT AND OBJECTIVE: Shoulder dislocation is the most common dislocation among the large joints. The aim here was to compare the effectiveness of reduction of acute anterior shoulder dislocation with or without articular anesthesia. DESIGN AND SETTING: Prospective randomized trial conducted in Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP) (EPM-UNIFESP). METHODS: From March 2008 to December 2009, 42 patients with shoulder dislocation were recruited. Reductions using traction-countertraction for acute anterior shoulder dislocation with and without lidocaine articular anesthesia were compared. As the primary outcome, pain was assessed through application of a visual analogue scale before reduction, and one and five minutes after the reduction maneuver was performed. Complications were also assessed. RESULTS: Forty-two patients were included: 20 in the group without analgesia (control group) and 22 in the group that received intra-articular lidocaine injection. The group that received intra-articular lidocaine had a statistically greater decrease in pain over time than shown by the control group, both in the first minute (respectively: mean 2.1 (0 to 5.0), standard deviation, SD 1.3, versus mean 4.9 (2.0 to 7.0, SD 1.5; P < 0.001) and the fifth minute (respectively: mean 1.0; 0 to 3.0; SD = 1.0 versus mean 4.0; 1.0 to 6.0; SD = 1.4; P < 0.001). There was one failure in the control group. There were no other complications in either group. CONCLUSION: Reduction of anterior shoulder dislocation using intra-articular lidocaine injection is effective, since it is safe and diminishes the pain. CLINICAL TRIAL REGISTRATION: ISRCTN27127703.CONTEXTO E OBJETIVO: A luxação do ombro é a mais frequente luxação das grandes articulações. O objetivo foi comparar a efetividade da redução da luxação anterior aguda do ombro, com ou sem anestesia articular. TIPO DE ESTUDO E LOCAL: Ensaio clínico randomizado desenvolvido na Escola Paulista de Medicina - Universidade Federal de São Paulo (UNIFESP) (EPM-UNIFESP). MÉTODOS: De março de 2008 a dezembro de 2009 foram recrutados 42 pacientes com luxação anterior do ombro agudas. Foi comparada a redução de tração e contra-tração com e sem anestesia intra-articular com lidocaína. Como desfecho primário, a dor foi avaliada por meio da escala visual analógica antes da redução e um e cinco minutos após a redução do ombro. Complicações também foram avaliadas. RESULTADOS: Foram incluídos 42 pacientes: 20 no grupo sem anestesia (grupo controle) e 22 no grupo que recebeu injeção intra-articular de lidocaína. O grupo que recebeu lidocaína intra-articular teve estatisticamente menos dor no primeiro (média = 2,1; 0 a 5,0, desvio padrão, DP, de 1,3, versus média = 4,9; 2,0 a 7,0; DP = 1,5; respectivamente; P < 0,001) e no quinto minutos (média = 1,0; 0 a 3,0; DP = 1,0 versus 4,0; 1,0 a 6,0; DP = 1,4; respectivamente; P < 0,001) após a redução em comparação ao grupo controle. Houve uma falha no grupo controle. Não houve complicações adicionais em ambos os grupos. CONCLUSÃO: A redução da luxação do ombro com o uso de lidocaína intra-articular é efetiva, pois é segura e proporciona menos dor. REGISTRO DE ENSAIO CLÍNICO: ISRCTN27127703Universidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Department of Orthopedics and TraumatologyUNIFESP, EPM, Department of Orthopedics and TraumatologySciEL

Outcomes in orthopedics and traumatology: translating research into practice

Clinical research is focused in generating evidence that is feasible to be applicable to practitioners. However, translating research-focused evidence into practice may be challenging and often misleading. This article aims is to pinpoint these challenges and suggest some methodological safeguards, taking platelet-rich plasma therapies and knee osteochondral injuries as examples. Studies and systematic reviews involving the following concepts will be investigated: clinically relevant outcomes, systematic errors on sample calculation, internal and external validity. Relevant studies on platelet-rich plasma for muscle-tendon lesions and updates on osteochondral lesions treatment were included in this analysis. Authors and clinicians should consider these concepts for the implementation and application of dissemination of the best evidence. Research results should be challenged by a weighted analysis of its methodological soundness and applicability. Level of Evidence V, Therapeutic Studies - Investigating the Results of Treatment.Universidade Federal de São Paulo (UNIFESP) Department of OrthopedicsUNIFESP, Department of OrthopedicsSciEL

Evaluation of patients with carpal tunnel syndrome treated by endoscopic technique

Objective:To evaluate the postoperative results of patients with carpal tunnel syndrome by the endoscopic release technique with single portal.Methods:78 patients (80 wrists) were evaluated preoperatively and postoperatively at 1, 3 and 6 months by the Boston questionnaire, the visual analogue scale (VAS) for pain, monofilament test sensitivity, grip strength, lateral pinch, pulp to pulp pinch and tripod pinch.Results:Statistical analysis was significant (p <0.05) in the progressive decline of pain and improved function (Boston) during follow-up. The sensitivity significantly improved comparing the data pre and postoperatively. The grip strength, lateral pinch, pulp to pulp pinch and tripod pinch decreased in the first month after surgery, returning to preoperative values around the third month postoperatively.Conclusion:The technique proved to be safe and effective in improving pain, function, and return sensitivity and strength. Level of Evidence II, Prospective studyUniversidade Federal de São Paulo (UNIFESP)UNIFESPSciEL