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SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures

Introduction: There is no consensus on which is the best way to maintain initial reduction of a distal radius fractures (DRFs). The aim of this study is to test the hypothesis that below elbow cast (BEC) is equivalent to above elbow cast (AEC) in maintaining initial reduction of DRFs. This paper wil...

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Autores principales: Tommaso, Maluta, Matteo, Cengarle, Giovanni, Dib, Alice, Bernasconi, Franco, Lavini, Matteo, Ricci, Eugenio, Vecchini, Elena, Manuela Samaila, Bruno, Magnan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mattioli 1885 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503394/
https://www.ncbi.nlm.nih.gov/pubmed/30714999
http://dx.doi.org/10.23750/abm.v90i1-S.8083
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author Tommaso, Maluta
Matteo, Cengarle
Giovanni, Dib
Alice, Bernasconi
Franco, Lavini
Matteo, Ricci
Eugenio, Vecchini
Elena, Manuela Samaila
Bruno, Magnan
author_facet Tommaso, Maluta
Matteo, Cengarle
Giovanni, Dib
Alice, Bernasconi
Franco, Lavini
Matteo, Ricci
Eugenio, Vecchini
Elena, Manuela Samaila
Bruno, Magnan
author_sort Tommaso, Maluta
collection PubMed
description Introduction: There is no consensus on which is the best way to maintain initial reduction of a distal radius fractures (DRFs). The aim of this study is to test the hypothesis that below elbow cast (BEC) is equivalent to above elbow cast (AEC) in maintaining initial reduction of DRFs. This paper will report on midterm results. Methods: SLA-VER is a prospective, monocentric, randomized, parallel-group, open label, blinded endpoint evaluation non-inferiority trial (PROBE design) comparing the efficacy of AECs and BECs in DRFs conservative treatment in terms of loss of radial height (RH), radial inclination (RI) and volar tilt (VT) during cast immobilization (average 35 days) of 353 consecutive DRFs. Non-inferiority thresholds are 2 mm for radial height, 3° for radial inclination and 3° for volar tilt. Study population will be 353 patients, randomized into 2 groups (AEC vs BEC). One-hundred patients have completed the study so far. Results: Patients in BEC group lost 1,75 mm of RH, 2,9° of RI and 4,5° of VT over the course of cast immobilization. Patients in AEC group lost 1,71 mm of RH, 2,2° of RI and 4,8° of VT. Raw differences between average loss of RH, RI, VT during treatment between study groups were respectively 0,04 mm, 0,7° and 0,3°. Logistic and ANCOVA models have been used to correct for confouding variables. Conclusions: Difference of loss of RH, RI and VT between the two groups are all below the non inferiority thresholds. Cast type does not seem to affect maintenance of reduction in conservatively managed DRFs. (www.actabiomedica.it)
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spelling pubmed-65033942019-05-08 SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures Tommaso, Maluta Matteo, Cengarle Giovanni, Dib Alice, Bernasconi Franco, Lavini Matteo, Ricci Eugenio, Vecchini Elena, Manuela Samaila Bruno, Magnan Acta Biomed Original Article Introduction: There is no consensus on which is the best way to maintain initial reduction of a distal radius fractures (DRFs). The aim of this study is to test the hypothesis that below elbow cast (BEC) is equivalent to above elbow cast (AEC) in maintaining initial reduction of DRFs. This paper will report on midterm results. Methods: SLA-VER is a prospective, monocentric, randomized, parallel-group, open label, blinded endpoint evaluation non-inferiority trial (PROBE design) comparing the efficacy of AECs and BECs in DRFs conservative treatment in terms of loss of radial height (RH), radial inclination (RI) and volar tilt (VT) during cast immobilization (average 35 days) of 353 consecutive DRFs. Non-inferiority thresholds are 2 mm for radial height, 3° for radial inclination and 3° for volar tilt. Study population will be 353 patients, randomized into 2 groups (AEC vs BEC). One-hundred patients have completed the study so far. Results: Patients in BEC group lost 1,75 mm of RH, 2,9° of RI and 4,5° of VT over the course of cast immobilization. Patients in AEC group lost 1,71 mm of RH, 2,2° of RI and 4,8° of VT. Raw differences between average loss of RH, RI, VT during treatment between study groups were respectively 0,04 mm, 0,7° and 0,3°. Logistic and ANCOVA models have been used to correct for confouding variables. Conclusions: Difference of loss of RH, RI and VT between the two groups are all below the non inferiority thresholds. Cast type does not seem to affect maintenance of reduction in conservatively managed DRFs. (www.actabiomedica.it) Mattioli 1885 2019 /pmc/articles/PMC6503394/ /pubmed/30714999 http://dx.doi.org/10.23750/abm.v90i1-S.8083 Text en Copyright: © 2019 ACTA BIO MEDICA SOCIETY OF MEDICINE AND NATURAL SCIENCES OF PARMA http://creativecommons.org/licenses/by-nc-sa/4.0 This work is licensed under a Creative Commons Attribution 4.0 International License
spellingShingle Original Article
Tommaso, Maluta
Matteo, Cengarle
Giovanni, Dib
Alice, Bernasconi
Franco, Lavini
Matteo, Ricci
Eugenio, Vecchini
Elena, Manuela Samaila
Bruno, Magnan
SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures
title SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures
title_full SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures
title_fullStr SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures
title_full_unstemmed SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures
title_short SLA-VER: study protocol description and preliminar results of the first italian RCT on conservative treatment of distal radial fractures
title_sort sla-ver: study protocol description and preliminar results of the first italian rct on conservative treatment of distal radial fractures
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503394/
https://www.ncbi.nlm.nih.gov/pubmed/30714999
http://dx.doi.org/10.23750/abm.v90i1-S.8083
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