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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 c...

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Autores principales: Raduan Neto, Jorge, de Moraes, Vinicius Ynoe, Gomes dos Santos, João B, Faloppa, Flávio, Belloti, João Carlos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3996038/
https://www.ncbi.nlm.nih.gov/pubmed/24597699
http://dx.doi.org/10.1186/1471-2474-15-65
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author Raduan Neto, Jorge
de Moraes, Vinicius Ynoe
Gomes dos Santos, João B
Faloppa, Flávio
Belloti, João Carlos
author_facet Raduan Neto, Jorge
de Moraes, Vinicius Ynoe
Gomes dos Santos, João B
Faloppa, Flávio
Belloti, João Carlos
author_sort Raduan Neto, Jorge
collection PubMed
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 für 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. TRIAL REGISTRATION: ISCRTN09599740
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spelling pubmed-39960382014-04-24 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 de Moraes, Vinicius Ynoe Gomes dos Santos, João B Faloppa, Flávio Belloti, João Carlos BMC Musculoskelet Disord 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 für 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. TRIAL REGISTRATION: ISCRTN09599740 BioMed Central 2014-03-05 /pmc/articles/PMC3996038/ /pubmed/24597699 http://dx.doi.org/10.1186/1471-2474-15-65 Text en Copyright © 2014 Raduan Neto et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Raduan Neto, Jorge
de Moraes, Vinicius Ynoe
Gomes dos Santos, João B
Faloppa, Flávio
Belloti, João Carlos
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
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_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_sort treatment of reducible unstable fractures of the distal radius: randomized clinical study comparing the locked volar plate and external fixator methods: study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3996038/
https://www.ncbi.nlm.nih.gov/pubmed/24597699
http://dx.doi.org/10.1186/1471-2474-15-65
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