15 research outputs found

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

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    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

    Circular saw misuse is related to upper limb injuries: a cross-sectional study

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    OBJECTIVES: Machinery injuries account for a substantial share of traumatic upper limb injuries (TULIs) affecting young active individuals. This study is based on the hypothesis that there is an important relationship between the improper use of power saws and TULIs. The aim of the study is to assess the prevalence and epidemiology of TULIs caused by power saws and determine the risks related to power saw use. METHODS: A cross-sectional evaluation of medical records from a two-year period was performed. Patients sustaining TULIs related to power saws were analyzed. Data on the epidemiology, site of injury, mechanism of trauma, technical specifications of the tool, cutting material, personal protective equipment, time lost and return to work were obtained. RESULTS: A database search retrieved 193 TULI records, of which 104 were related to power saws. The majority of patients were male (102/104; 98.1%), right-handed (97/104; 93.3%), and manual workers (46/104; 44.2%), with an average age of 46.8 years. The thumb was the most frequently injured site (32/93; 34.4%). Most of the injuries were caused by manual saws (85/104; 81.7%), and masonry saws accounted for 68.2% (58/85) of the cases. Masonry saws improperly used for woodwork resulted in 86.2% (50/58) of the injuries. TULI caused by masonry saws was 5 times higher in manual workers than in other patients. In addition, masonry saws had a risk of kickback 15 times higher than that of other saws, and the risk of injury increased by 5.25 times when the saws were used improperly for wood cutting. CONCLUSIONS: The profile of TULIs related to power saws was demonstrated and was mainly associated with manual saws operated by manual workers that inappropriately used masonry saws for woodworking

    Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review

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    ABSTRACT BACKGROUND: The diagnostic criteria for carpal tunnel syndrome (CTS) lack uniformity. Moreover, because CTS is a syndrome, there is no consensus as to which signs, symptoms, clinical and complementary tests are more reproducible and accurate for use in clinical research. This heterogeneity is reflected in clinical practice. Thus, establishing effective and comparable care protocols is difficult. OBJECTIVE: To identify the diagnostic criteria and outcome measures used in randomized clinical trials (RCTs) on CTS. DESING AND SETTING: Systematic review of randomized clinical trials carried out at the Federal University of São Paulo, São Paulo, Brazil. METHODS: We searched the Cochrane Library, PubMed, and Embase databases for RCTs with surgical intervention for CTS published between 2006 and 2019. Two investigators independently extracted relevant data on diagnosis and outcomes used in these studies. RESULTS: We identified 582 studies and 35 were systematically reviewed. The symptoms, paresthesia in the median nerve territory, nocturnal paresthesia, and special tests were the most widely used clinical diagnostic criteria. The most frequently assessed outcomes were symptoms of paresthesia in the median nerve territory and nocturnal paresthesia. CONCLUSION: The diagnostic criteria and outcome measures used in RCTs about CTS are heterogeneous, rendering comparison of studies difficult. Most studies use unstructured clinical criteria associated with ENMG for diagnosis. The Boston Questionnaire is the most frequently used main instrument to measure outcomes. REGISTRATION: PROSPERO (CRD42020150965- https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965)

    Collaborative multicenter trials in Latin America: challenges and opportunities in orthopedic and trauma surgery

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    CONTEXT AND OBJECTIVE Orthopedic research agendas should be considered from a worldwide perspective. Efforts should be planned as the means for obtaining evidence that is valid for health promotion with global outreach. DESIGN AND SETTING Exploratory study conducted at Universidade Federal de São Paulo (Unifesp), São Paulo, Brazil, and McMaster University, Hamilton, Canada. METHODS We identified and analyzed collaborative and multicenter research in Latin America, taking into account American and Canadian efforts as the reference points. We explored aspects of the data available from official sources and used data from traffic accidents as a model for discussing collaborative research in these countries. RESULTS The evaluation showed that the proportion of collaborative and multicenter studies in our setting is small. A brief analysis showed that the death rate due to traffic accidents is very high. Thus, it seems clear to us that initiatives involving collaborative studies are important for defining and better understanding the patterns of injuries resulting from orthopedic trauma and the forms of treatment. Orthopedic research may be an important tool for bringing together orthopedic surgeons, researchers and medical societies for joint action. CONCLUSIONS We have indicated some practical guidelines for initiatives in collaborative research and have proposed some solutions with a summarized plan of action for conducting evidence-based research involving orthopedic trauma

    Above-versus below-elbow casting for conservative treatment of distal radius fractures: a randomized controlled trial and study protocol

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    Abstract Background A variety of cast options are available for the non-surgical treatment of distal radius fractures (DRF) in adults. However, the literature is inconclusive regarding the need to immobilize the elbow joint after reduction in order to prevent rotation of the forearm in order to maintain the reduction of DRF. This study aimed to evaluate the best method of immobilization between above-elbow (AE) and below-elbow (BE) cast groups at the end of six-month follow-up. Methods This is a randomized clinical trial with parallel groups and a blinded evaluator. There are two non-surgical interventions: AE and BE. Patients will be randomly assigned. A hundred twenty eight consecutive adult patients with acute (up to 7 days) displaced DRF of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification will be included. The primary outcome will be the maintenance of reduction by evaluation of radiographic parameters and Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Secondary outcomes include function measured by Patient Rated Wrist Evaluation (PRWE), pain measured by the Visual Analogue Scale (VAS), objective functional evaluation (goniometry and dynamometry) and rate of complications. Evaluations will be performed at 1, 2, 3, 4, 6, 8, 12 and 24 weeks. For the Student’s t-test, a difference of 10 points in DASH score, with 95% confidence interval, a statistical power of 95%, and 20% sampling error. We consider an extra 10% for balancing follow up losses results in 64 patients per group. Discussion Results from this study protocol will help to define the need for elbow immobilization in maintenance of reduction, as well as functional performance of below elbow cast versus above elbow cast immobilization during the immobilization period. Trial registration NCT03126175 (http://clinicaltrials.gov). April 24, 2017
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