Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol
Autor(a) principal: | |
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Data de Publicação: | 2014 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNIFESP |
Texto Completo: | http://repositorio.unifesp.br/handle/11600/37543 http://dx.doi.org/10.1186/1471-2474-15-65 |
Resumo: | 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. |
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Raduan Neto, Jorge [UNIFESP]Moraes, Vinicius Ynoe de [UNIFESP]Santos, João Baptista Gomes dos [UNIFESP]Faloppa, Flávio [UNIFESP]Belloti, João Carlos [UNIFESP]Universidade Federal de São Paulo (UNIFESP)Hand Arm & Shoulder Surg Unit2016-01-24T14:35:26Z2016-01-24T14:35:26Z2014-03-05Bmc Musculoskeletal Disorders. London: Biomed Central Ltd, v. 15, 7 p., 2014.1471-2474http://repositorio.unifesp.br/handle/11600/37543http://dx.doi.org/10.1186/1471-2474-15-65WOS000335176600001.pdf10.1186/1471-2474-15-65WOS:000335176600001Background: 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 Science7engBiomed Central LtdBmc Musculoskeletal DisordersDistal radius fractureVolar plateExternal fixatorRandomizedProspective (annex 1)Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocolinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESPORIGINALWOS000335176600001.pdfapplication/pdf466309${dspace.ui.url}/bitstream/11600/37543/1/WOS000335176600001.pdfce59da4355579aad3a6fb4b5c31bfcc1MD51open accessTEXTWOS000335176600001.pdf.txtWOS000335176600001.pdf.txtExtracted texttext/plain31371${dspace.ui.url}/bitstream/11600/37543/21/WOS000335176600001.pdf.txtec1a986848fbd2736782ea6dbeec3b9dMD521open accessTHUMBNAILWOS000335176600001.pdf.jpgWOS000335176600001.pdf.jpgIM Thumbnailimage/jpeg6626${dspace.ui.url}/bitstream/11600/37543/23/WOS000335176600001.pdf.jpg37c0a577d0c9c6063766ef505fa03df2MD523open access11600/375432023-06-05 20:15:21.798open accessoai:repositorio.unifesp.br:11600/37543Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestopendoar:34652023-06-05T23:15:21Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false |
dc.title.en.fl_str_mv |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol |
title |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol |
spellingShingle |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol Raduan Neto, Jorge [UNIFESP] Distal radius fracture Volar plate External fixator Randomized Prospective (annex 1) |
title_short |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol |
title_full |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol |
title_fullStr |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol |
title_full_unstemmed |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol |
title_sort |
Treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol |
author |
Raduan Neto, Jorge [UNIFESP] |
author_facet |
Raduan Neto, Jorge [UNIFESP] Moraes, Vinicius Ynoe de [UNIFESP] Santos, João Baptista Gomes dos [UNIFESP] Faloppa, Flávio [UNIFESP] Belloti, João Carlos [UNIFESP] |
author_role |
author |
author2 |
Moraes, Vinicius Ynoe de [UNIFESP] Santos, João Baptista Gomes dos [UNIFESP] Faloppa, Flávio [UNIFESP] Belloti, João Carlos [UNIFESP] |
author2_role |
author author author author |
dc.contributor.institution.none.fl_str_mv |
Universidade Federal de São Paulo (UNIFESP) Hand Arm & Shoulder Surg Unit |
dc.contributor.author.fl_str_mv |
Raduan Neto, Jorge [UNIFESP] Moraes, Vinicius Ynoe de [UNIFESP] Santos, João Baptista Gomes dos [UNIFESP] Faloppa, Flávio [UNIFESP] Belloti, João Carlos [UNIFESP] |
dc.subject.eng.fl_str_mv |
Distal radius fracture Volar plate External fixator Randomized Prospective (annex 1) |
topic |
Distal radius fracture Volar plate External fixator Randomized Prospective (annex 1) |
description |
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. |
publishDate |
2014 |
dc.date.issued.fl_str_mv |
2014-03-05 |
dc.date.accessioned.fl_str_mv |
2016-01-24T14:35:26Z |
dc.date.available.fl_str_mv |
2016-01-24T14:35:26Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
Bmc Musculoskeletal Disorders. London: Biomed Central Ltd, v. 15, 7 p., 2014. |
dc.identifier.uri.fl_str_mv |
http://repositorio.unifesp.br/handle/11600/37543 http://dx.doi.org/10.1186/1471-2474-15-65 |
dc.identifier.issn.none.fl_str_mv |
1471-2474 |
dc.identifier.file.none.fl_str_mv |
WOS000335176600001.pdf |
dc.identifier.doi.none.fl_str_mv |
10.1186/1471-2474-15-65 |
dc.identifier.wos.none.fl_str_mv |
WOS:000335176600001 |
identifier_str_mv |
Bmc Musculoskeletal Disorders. London: Biomed Central Ltd, v. 15, 7 p., 2014. 1471-2474 WOS000335176600001.pdf 10.1186/1471-2474-15-65 WOS:000335176600001 |
url |
http://repositorio.unifesp.br/handle/11600/37543 http://dx.doi.org/10.1186/1471-2474-15-65 |
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eng |
language |
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Bmc Musculoskeletal Disorders |
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7 |
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Biomed Central Ltd |
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Biomed Central Ltd |
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