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.

Surgical Treatment of Comminuted Midshaft Clavicle Fracture by Minimally Invasive Technique: Description and Preliminary Results.

Objective The present paper aimed to evaluate functional and radiographic outcomes from a group of patients with comminuted midshaft clavicle fracture who were surgically treated using a minimally invasive technique and followed-up for a minimum period of 12 months. Methods Longitudinal, observational study with 32 consecutive patients (31 males; mean age, 41 years old) with comminuted midshaft clavicle fracture who were surgically treated using the minimally invasive osteosynthesis technique with a 3.5-mm reconstruction plate in the upper position. Patients were clinically and radiologically evaluated for a minimum follow-up period of 12 months. Results In 30 patients (93.72%), fracture consolidation occurred in an average time of 17 weeks (range, 12 to 24 weeks). The mean follow-up time was 21 months (range, 12 to 45 months). No implant break or pseudoarthrosis were recorded. There was no complaint of paresthesia around the surgical incisions. The surgically-treated shoulder presented lower passive elevation and longer clavicle length ( p < 0.05) compared with the contralateral shoulder. Functional evaluation revealed an average Disability of Arm, Shoulder and Hand (DASH) score of 1.75, which is considered satisfactory. Age > 60 years old had a negative correlation with DASH score (p <0.05). Conclusion The minimally invasive osteosynthesis technique was satisfactory for the treatment of comminuted midshaft clavicle fracture, with a high consolidation rate and a low complication rate.

Surgical Treatment of Comminuted Midshaft Clavicle Fracture by Minimally Invasive Technique: Description and Preliminary Results / Tratamento cirúrgico da fratura multifragmentada da diáfise da clavícula pela técnica minimamente invasiva: Descrição e resultados preliminares

Abstract Objective Thepresentpaperaimedtoevaluatefunctionalandradiographicoutcomesfrom a group of patients with comminuted midshaft clavicle fracture who were surgically treated using a minimally invasive technique and followed-up for a minimum period of 12 months. Methods Longitudinal, observational study with 32 consecutive patients (31 males; mean age, 41 years old) with comminuted midshaft clavicle fracture who were surgically treated using the minimally invasive osteosynthesis technique with a 3.5mm reconstruction plate in the upper position. Patients were clinically and radiologically evaluated for a minimum follow-up period of 12 months. Results In 30 patients (93.72%), fracture consolidation occurred in an average time of 17 weeks (range, 12 to 24 weeks). The mean follow-up time was 21 months (range, 12 to 45 months). No implant break or pseudoarthrosis were recorded. There was no complaint of paresthesia around the surgical incisions. The surgically-treated shoulder presented lower passive elevation and longer clavicle length (p < 0.05) compared with the contralateral shoulder. Functional evaluation revealed an average Disability of Arm, Shoulder and Hand (DASH) score of 1.75, which is considered satisfactory. Age > 60 years old had a negative correlation with DASH score (p <0.05). Conclusion The minimally invasive osteosynthesis technique was satisfactory for the treatment of comminuted midshaft clavicle fracture, with a high consolidation rate and a low complication rate.

Resumo Objetivo Avaliar os resultados funcionais e radiográficos do tratamento cirúrgico realizado em um grupo de pacientes com fratura multifragmentada da diáfise de clavícula, pela técnica minimamente invasiva, em seguimento mínimo de 12 meses. Métodos Estudo observacional longitudinal de 32 pacientes consecutivos (31 do sexo masculino, idade média 41 anos) com fratura multifragmentada da diáfise da clavícula tratados cirurgicamente pela técnica minimamente invasiva de osteossíntese com placa de reconstrução de 3,5 mm na posição superior, avaliados clínica e radiologicamente, com seguimento mínimo de 1 ano Resultados Resultados Trinta pacientes (93,72%) evoluíram com consolidação da fratura em tempo médio de 17 semanas (entre 12 e 24 semanas). O tempo de seguimento médio foi de 21 meses (variando de 12 a 45 meses). Não houve quebra de implantes ou pseudoartroses. Não houve queixa de parestesia na região das incisões cirúrgicas. O ombro tratado cirurgicamente apresentou menor elevação passiva e maior comprimento da clavícula (p< 0,05) em relação ao contralateral. Na avaliação funcional, encontramos um valor médio de Disfunções do Braço, Ombro e Mão (DASH, na sigla em inglês) = 1,75, sendo o mesmo considerado satisfatório. Idade >60 anos apresentou correlação negativa com escore DASH (p< 0,05). Conclusão A técnica minimamente invasiva de osteossíntese mostrou-se satisfatória para o tratamento da fratura multifragmentada da diáfise da clavícula, com elevada taxa de consolidação e baixo índice de complicações.

Functional and Radiological Outcomes of the Surgical Treatment of Acute Acromioclavicular Dislocation with Anchors Associated with Clavicle and Scapula Fixation.

Objective To evaluate the clinical, radiological and functional results of the surgical treatment of acute acromioclavicular dislocation using a coracoclavicular fixation technique (syndesmopexy) with two metallic anchors, temporary clavicle and scapula fixation, and transfer of the coracoacromial ligament. Methods Longitudinal observational study of 30 patients with diagnoses of acute acromioclavicular dislocation, who were submitted to surgical treatment with a minimum follow-up of six months, and who were evaluated clinically, radiologically, and by the University of California at Los Angeles (UCLA), the Disabilities of the Arm, Shoulder and Hand (DASH) and the Constant-Murley functional scores. Results The mean values of the scores were: UCLA = 32; DASH = 11.21; and Constant-Murley = 86.93, with satisfactory results higher than 80%. The unsatisfactory results were associated with acromioclavicular pain on palpation, positive subacromial impingement tests, and older age group, presenting statistical significance ( p < 0.05). Radiologically, higher values on account of the coracoclavicular distance ratio from the operated shoulder compared to the normal shoulder were related to worse outcomes, but with no statistically significant difference. No associations were found between the results of the functional scores and the variables degree of the injury, coracoacromial ligament transfer, clinical impression of loss of reduction and scapulothoracic dyskinesis. Conclusion The technique used provides an efficient fixation, with a high level of satisfaction according to the UCLA, Constant-Murley and DASH scores; moreover, it has a low complication rate, despite the high rate of residual radiological acromioclavicular subluxation.

Functional and Radiological Outcomes of the Surgical Treatment of Acute Acromioclavicular Dislocation with Anchors Associated with Clavicle and Scapula Fixation / Resultados funcionais e radiológicos do tratamento cirúrgico da luxação acromioclavicular aguda com âncoras e fixação clavículo-escapular

Abstract Objective To evaluate the clinical, radiological and functional results of the surgical treatment of acute acromioclavicular dislocation using a coracoclavicular fixation technique (syndesmopexy) with two metallic anchors, temporary clavicle and scapula fixation, and transfer of the coracoacromial ligament. Methods Longitudinal observational study of 30 patients with diagnoses of acute acromioclavicular dislocation, who were submitted to surgical treatment with a minimum follow-up of six months, and who were evaluated clinically, radiologically, and by the University of California at Los Angeles (UCLA), the Disabilities of the Arm, Shoulder and Hand (DASH) and the Constant-Murley functional scores. Results The mean values of the scores were: UCLA = 32; DASH = 11.21; and Constant-Murley = 86.93, with satisfactory results higher than 80%. The unsatisfactory results were associated with acromioclavicular pain on palpation, positive subacromial impingement tests, and older age group, presenting statistical significance (p < 0.05). Radiologically, higher values on account of the coracoclavicular distance ratio from the operated shoulder compared to the normal shoulder were related to worse outcomes, but with no statistically significant difference. No associations were found between the results of the functional scores and the variables degree of the injury, coracoacromial ligament transfer, clinical impression of loss of reduction and scapulothoracic dyskinesis. Conclusion The technique used provides an efficient fixation, with a high level of satisfaction according to the UCLA, Constant-Murley and DASH scores; moreover, it has a low complication rate, despite the high rate of residual radiological acromioclavicular subluxation.

Resumo Objetivo Avaliar os resultados clínicos, radiológicos, e funcionais do tratamento cirúrgico da luxação acromioclavicular aguda, utilizando a técnica de sindesmopexia coracoclavicular com duas âncoras metálicas, fixação temporária clavículo-escapular, e transferência do ligamento coracoacromial. Métodos Estudo observacional longitudinal com trinta pacientes com diagnóstico de luxação acromioclavicular aguda submetidos à cirurgia, com seguimento mínimo de seis meses, avaliados clínica, radiograficamente, e pelos escores de University of California at Los Angeles (UCLA), Disabilities of the Arm, Shoulder and Hand (DASH) e Constant-Murley. Resultados Os valores médios dos escores foram: UCLA = 32; DASH = 11,21; e Constant-Murley = 86,93, com resultados satisfatórios acima de 80%. Os resultados insatisfatórios foram relacionados à dor acromioclavicular, a testes de impacto subacromial positivos, e aos pacientes de faixa etária mais elevada (p < 0,05). Radiologicamente, valores maiores em razão da distância coracoclavicular do ombro operado, comparado com o ombro normal, foram relacionados a piores resultados, embora sem significância estatística. Não foi observada associação entre os resultados dos escores funcionais e as variáveis grau da lesão, transferência do ligamento coracoacromial, impressão clínica de perda de redução, e discinesia escapulo-torácica. Conclusão A técnica utilizada propicia uma fixação eficiente, com alto índice de satisfação segundo os escores de UCLA, Constant-Murley e DASH. Observou-se baixo índice de complicações apesar da frequência elevada de subluxação acromioclavicular radiológica residual.

USE OF THE PFO(®) NUT IN TREATING FRACTURES OF THE PROXIMAL THIRD OF THE HUMERUS IN PATIENTS WITH BONE FRAGILITY.

OBJECTIVE: To evaluate the clinical results from application of the PFO(®) bone fixation nut, which was developed for use with 4.5 mm cortical screws, and to analyze any complications or bone reactions caused by this synthesis in porotic bone. METHOD: Between May 1999 and November 2007, the PFO(®) nut was used on 23 patients who underwent osteosynthesis with a PFS 80(®) plate in the proximal segment, to treat acute fractures, pseudarthrosis or defective consolidations. The average age of the patients was 69 years, and the average length of follow-up was 40 months. RESULTS: Only one patient did not present consolidation. The complications observed were: two cases of medial cortical fracture; one case of loosening of the nut; three cases of bone reabsorption around the PFO(®), but two of these without clinical repercussions; and one case in which the fracture failed to consolidate, with consequent loosening of the fracture. CONCLUSION: The authors conclude that the use of the PFO(®) nut is a practical and effective alternative for osteosynthesis in patients with fractures of the proximal segment or sequelae from fractures of the humerus associated with bone fragility.

Utilização da porca PFO® no tratamento de fraturas do terço proximal do úmero em pacientes com fragilidade óssea / Use of the PFO® nut in the treatment of fractures of the humerus proximal third in patients with bone fragility

OBJETIVO: Avaliar os resultados clínicos da aplicação de porca para fixação óssea PFO®, que foi desenvolvida para ser usada com parafusos corticais de 4,5mm, analisando eventuais complicações ou reação óssea que a síntese poderia provocar em ossos poróticos. MÉTODO: Entre maio de 1999 e novembro de 2007, a PFO® foi utilizada em 23 pacientes, submetidos à osteossíntese com placa PFS 80® no segmento proximal do úmero para tratamento de fraturas agudas, pseudartroses ou consolidações viciosas. A média de idade foi de 69 anos e o seguimento médio de 40 meses. RESULTADOS: Apenas um paciente não apresentou consolidação. As complicações observadas foram: dois casos de fratura da cortical medial; um caso de soltura da porca; em três casos verificou-se reabsorção óssea ao redor da PFO®, porém dois sem repercussão clínica, e, em apenas um deles, não houve consolidação da fratura, com consequente soltura da mesma. CONCLUSÃO: Os autores concluem que a utilização da porca se constitui em uma opção prática e efetiva na osteossíntese dos pacientes com fraturas do segmento proximal ou sequelas de fratura do úmero associadas à fragilidade óssea.

OBJECTIVE: To evaluate the clinical results of the application of the PFO® bone fixation nut, which was developed for use with 4.5 mm cortical screws, analyzing any complications or bone reaction caused by its synthesis in porotic bone. METHOD: From May 1999 to November 2007, the PFO® nut was used on 23 patients submitted to osteosynthesis with a PFS 80® plate in the humerus proximal segment, for the treatment of acute fractures, pseudarthrosis, or defective consolidations. The average age of the patients was 69 years, and the average follow-up time was 40 months. RESULTS: Only one patient presented no complications. The complications observed were: two cases of medial cortical fracture; one case of loosening of the nut; three cases of bone reabsorption around the PFO®, but two of these without clinical repercussions; and one case in which the fracture failed to consolidate, with consequent loosening of the fracture. CONCLUSION: The authors conclude that the use of the PFO® nut is a practical and effective alternative for osteosynthesis in patients with fractures of the proximal segment or complications of fracture of the humerus associated with bone fragility.

Avaliação dos resultados do tratamento artroscópico da epicondilite lateral / Evaluation of the results of arthroscopic treatment of the lateral epicondylitis

OBJETIVO: Avaliar os resultados dos pacientes com epicondilite lateral tratados cirurgicamente pela técnica artroscópica. MÉTODOS: Vinte pacientes foram operados pela técnica artroscópica. A idade variou de 19 a 54 anos (média de 41 anos e oito meses), sendo 12 (60 por cento) pacientes do sexo feminino e oito (40 por cento), do masculino. O seguimento mínimo foi de 12 meses e o máximo, de 48 meses, sendo a média de 20 meses. Todos os casos eram refratários ao tratamento conservador (repouso e fisioterapia), com tempo de tratamento clínico prévio variando entre seis e 136 meses. Para a avaliação dos resultados utilizamos os critérios da Associação Médica Americana (AMA), modificados por Bruce. RESULTADOS: Obtivemos 13 (65 por cento) resultados excelentes e sete (13 por cento) regulares, com apenas uma complicação (distrofia simpático-reflexa). Este foi o único caso que referiu não estar satisfeito. CONCLUSÃO: O tratamento cirúrgico pela técnica artroscópica da epicondilite lateral do cotovelo representa uma boa opção para 65 por cento dos casos.

OBJECTIVE: To evaluate the results in patients with lateral epicondylitis surgically treated by the arthroscopy technique. METHODS: Twenty patients were submitted to surgery by the arthroscopic technique. Age ranged from 19 to 54 years (average 41 years and eight months). Twelve (60 percent) of the patients were female and eight (40 percent) male. The minimum follow-up period was 12 months and the maximum period, 48 months, with an average of 20 months. All the cases were refractory to conservative treatment (rest and physiotherapy), with previous clinical treatment times varying ranging from six to 136 months. For the evaluation of the results, we used the criteria of the American Medical Association (AMA), modified by Bruce. RESULTS: We obtained 13 (65 percent) excellent results and seven (13 percent) regular results, with just one complication (reflex sympathetic dystrophy). This was the only patient who reported dissatisfaction. CONCLUSION: Surgical treatment by arthroscopy of the lateral epicondylitis of the elbow represents a good option in 65 percent of cases.