Protocol of BRICS: Brazilian multicentric pragmatic randomised trial of surgical interventions for displaced diaphyseal clavicle fracture study: MIPO versus ORIF for the treatment of displaced midshaft clavicle fractures.

INTRODUCTION: Fractures of the diaphysis of the clavicle are common; however, treatment guidelines for this condition are lacking. Surgery is associated with a lower risk of non-union and better functional outcomes but a higher risk of complications. Open reduction and internal fixation with plates and screws are the most commonly performed techniques, but they are associated with paraesthesia in the areas of incisions, extensive surgical exposure and high rates of implant removal. Minimally invasive techniques for treating these fractures have a lower rate of complications. The aim of this study is to evaluate which surgical treatment option (minimally invasive osteosynthesis or open reduction and internal fixation) has better prognosis in terms of complications and reoperations. METHODS AND ANALYSIS: The study proposed is a multicentric, pragmatic, randomised, open-label, superiority clinical trial between minimally invasive osteosynthesis and open reduction and internal fixation for surgical treatment of patients with displaced fractures of the clavicle shaft. In the proposed study, 190 individuals with displaced midshaft clavicle fractures, who require surgery as treatment, will be randomised. The assessment will occur at 2, 6, 12, 24 and 48 weeks, respectively. The primary outcome of the study will be the number of complications and reoperations. For sample size calculation, a moderate effective size between the techniques was considered in a two-tailed test, with 95% confidence and 90% power. Complications include cases of infection, hypertrophic scarring, non-union, refracture, implant failure, hypoesthesia, skin irritation and shoulder pain. Reoperations are defined as the number of surgeries for pseudoarthrosis, implant failure, infection and elective removal of the implant. ETHICS AND DISSEMINATION: Study approved by the institutional ethics committee (number 34249120.9.0000.5505-V.3). The results will be disseminated by publications in peer-reviewed journals and presentations in medical meetings. TRIAL REGISTRATION NUMBER: RBR-3czz68)/UTN U1111-1257-8953.

Are classifications of proximal radius fractures reproducible?

BACKGROUND: Fractures of the proximal radius need to be classified in an appropriate and reproducible manner. The aim of this study was to assess the reliability of the three most widely used classification systems. METHODS: Elbow radiographs images of patients with proximal radius fractures were classified according to Mason, Morrey, and Arbeitsgemeinschaft für osteosynthesefragen/Association for the Study of Internal Fixation (AO/ASIF) classifications by four observers with different experience with this subject to assess their intra- and inter-observer agreement. Each observer analyzed the images on three different occasions on a computer with numerical sequence randomly altered. RESULTS: We found that intra-observer agreement of Mason and Morrey classifications were satisfactory (kappa = 0.582 and 0.554, respectively), while the AO/ASIF classification had poor intra-observer agreement (kappa = 0.483). Inter-observer agreement was higher in the Mason (kappa = 0.429-0.560) and Morrey (kappa = 0.319-0.487) classifications than in the AO/ASIF classification (kappa = 0.250-0.478), which showed poor reliability. CONCLUSION: Inter- and intra-observer agreement of the Mason and Morey classifications showed overall satisfactory reliability when compared to the AO/ASIF system. The Mason classification is the most reliable system.

Tratamento da síndrome do túnel ulnar pela técnica da epicondilectomia parcial medial do cotovelo / Treatment of cubital tunnel syndrome using the technique of medial partial epicondylectomy of the elbow

OBJETIVO: Analisamos retrospectivamente os resultados de 21 casos de síndrome cubital tratados cirurgicamente com a técnica da epicondilectomia parcial medial. MÉTODOS: No período de fevereiro de 2001 a outubro de 2006, 21 pacientes com síndrome do canal cubital foram tratados pela técnica da epicondilectomia parcial medial do cotovelo associada à neurólise do nervo ulnar. Destes, 12 (57,1 por cento) eram do sexo masculino. O lado direito foi o acometido em 15 (71,4 por cento) pacientes. A média da idade dos pacientes foi de 51,6 anos. Pela graduação de McGowan, seis (28,6 por cento) pacientes encontravam-se no grau I, 11 (52,3 por cento), no grau II e quatro (19,1 por cento), no grau III do período pré-operatório. RESULTADOS: O tempo médio de acompanhamento pós-operatório foi de 25,7 meses. No pós-operatório, os pacientes foram avaliados conforme a escala de pontos de Bishop, sendo que nove (42,8 por cento) apresentavam resultados excelentes, sete (33,3 por cento), bons, três (14,2 por cento), regulares e dois (9,5 por cento), ruins. Nesta série, não se encontraram como complicações a instabilidade em valgo residual, a lesão permanente do nervo ulnar, a recidiva da compressão ou a subluxação do nervo ulnar. As complicações encontradas foram perda do arco de movimento em um (4,7 por cento) caso, infecção superficial em um (4,7 por cento) e um (4,7 por cento) com dor residual. CONCLUSÃO: Os resultados apresentados permitem concluir que a epicondilectomia parcial medial do cotovelo associada à neurólise do nervo ulnar é eficiente e segura para o tratamento da síndrome do canal cubital.

OBJECTIVE: The authors made a retrospective analysis of the results of 21 cases of cubital syndrome that were surgically treated with the partial medial epicondylectomy. METHODS: From February 2001 to October 2006, 21 patients with cubital tunnel syndrome were treated with the technique of elbow partial medial epicondylectomy associated to neurolysis of the ulnar nerve. Of these patients, 12 (57.1 percent) were male. The right side was involved in 15 (71.4 percent). Mean age of the patients was 51.6 years. According to McGowan classification, six (28.6 percent) patients were grade I, 11 (52.3 percent), grade II, and four (19.1 percent), grade III in the preoperative period. RESULTS: The mean post-operative follow-up time was 25.7 months. In the post-operative period, patients were evaluated according to the Bishop score scale, and nine of them (42.8 percent) showed excellent results, seven (33.3 percent) had good results, three (14.2 percent), regular, and two patients (9.5 percent) had poor results. The authors did not find in this series any complications represented by residual valgus instability, permanent lesion of the ulnar nerve, recurrent compression, or subluxation of the ulnar nerve. Complications found were the loss of the movement arch in one case (4.7 percent), superficial infection in one case (4.7 percent), and residual pain in one case (4.7 percent). CONCLUSION: The results allow for the conclusion that partial medial epicondylectomy of the elbow associated to neurolysis of the ulnar nerve is effective and safe to treat cubital tunnel syndrome.