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The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults
BACKGROUND: There is no consensus concerning the optimal casting technique for displaced distal radius fractures (DRFs) following closed reduction. This study evaluates whether a splint or a circumferential cast is most optimal to prevent fracture redisplacement in adult patients with a reduced DRF....
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059188/ https://www.ncbi.nlm.nih.gov/pubmed/33879131 http://dx.doi.org/10.1186/s12891-021-04238-0 |
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author | Barvelink, Britt Reijman, Max Schep, Niels W. L. Brown, Vanessa Kraan, Gerald A. Gosens, Taco Polinder, Suzanne Ista, Erwin Verhaar, Jan A. N. Colaris, Joost W. |
author_facet | Barvelink, Britt Reijman, Max Schep, Niels W. L. Brown, Vanessa Kraan, Gerald A. Gosens, Taco Polinder, Suzanne Ista, Erwin Verhaar, Jan A. N. Colaris, Joost W. |
author_sort | Barvelink, Britt |
collection | PubMed |
description | BACKGROUND: There is no consensus concerning the optimal casting technique for displaced distal radius fractures (DRFs) following closed reduction. This study evaluates whether a splint or a circumferential cast is most optimal to prevent fracture redisplacement in adult patients with a reduced DRF. Additionally, the cost-effectiveness of both cast types will be calculated. METHODS/DESIGN: This multicenter cluster randomized controlled trial will compare initial immobilization with a circumferential below-elbow cast versus a below-elbow plaster splint in reduced DRFs. Randomization will take place on hospital-level (cluster, n = 10) with a cross-over point halfway the inclusion of the needed number of patients per hospital. Inclusion criteria comprise adult patients (≥ 18 years) with a primary displaced DRF which is treated conservatively after closed reduction. Multiple trauma patients (Injury Severity Score ≥ 16), concomitant ulnar fractures (except styloid process fractures) and patients with concomitant injury on the ipsilateral arm or inability to complete study forms will be excluded. Primary study outcome is fracture redisplacement of the initial reduced DRF. Secondary outcomes are patient-reported outcomes assessed with the Disability Arm Shoulder Hand score (DASH) and Patient-Rated Wrist Evaluation score (PRWE), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, analgesics use, cost-effectiveness and (serious) adverse events occurence. In total, 560 patients will be included and followed for 1 year. The estimated time required for inclusion will be 18 months. DISCUSSION: The CAST study will provide evidence whether the type of cast immobilization is of influence on fracture redisplacement in distal radius fractures. Extensive follow-up during one year concerning radiographic, functional and patient reported outcomes will give a broad view on DRF recovery. TRIAL REGISTRATION: Registered in the Dutch Trial Registry on January 14th 2020. Registration number: NL8311. |
format | Online Article Text |
id | pubmed-8059188 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-80591882021-04-21 The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults Barvelink, Britt Reijman, Max Schep, Niels W. L. Brown, Vanessa Kraan, Gerald A. Gosens, Taco Polinder, Suzanne Ista, Erwin Verhaar, Jan A. N. Colaris, Joost W. BMC Musculoskelet Disord Study Protocol BACKGROUND: There is no consensus concerning the optimal casting technique for displaced distal radius fractures (DRFs) following closed reduction. This study evaluates whether a splint or a circumferential cast is most optimal to prevent fracture redisplacement in adult patients with a reduced DRF. Additionally, the cost-effectiveness of both cast types will be calculated. METHODS/DESIGN: This multicenter cluster randomized controlled trial will compare initial immobilization with a circumferential below-elbow cast versus a below-elbow plaster splint in reduced DRFs. Randomization will take place on hospital-level (cluster, n = 10) with a cross-over point halfway the inclusion of the needed number of patients per hospital. Inclusion criteria comprise adult patients (≥ 18 years) with a primary displaced DRF which is treated conservatively after closed reduction. Multiple trauma patients (Injury Severity Score ≥ 16), concomitant ulnar fractures (except styloid process fractures) and patients with concomitant injury on the ipsilateral arm or inability to complete study forms will be excluded. Primary study outcome is fracture redisplacement of the initial reduced DRF. Secondary outcomes are patient-reported outcomes assessed with the Disability Arm Shoulder Hand score (DASH) and Patient-Rated Wrist Evaluation score (PRWE), comfort of the cast, quality of life assessed with the EQ-5D-5L questionnaire, analgesics use, cost-effectiveness and (serious) adverse events occurence. In total, 560 patients will be included and followed for 1 year. The estimated time required for inclusion will be 18 months. DISCUSSION: The CAST study will provide evidence whether the type of cast immobilization is of influence on fracture redisplacement in distal radius fractures. Extensive follow-up during one year concerning radiographic, functional and patient reported outcomes will give a broad view on DRF recovery. TRIAL REGISTRATION: Registered in the Dutch Trial Registry on January 14th 2020. Registration number: NL8311. BioMed Central 2021-04-20 /pmc/articles/PMC8059188/ /pubmed/33879131 http://dx.doi.org/10.1186/s12891-021-04238-0 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Barvelink, Britt Reijman, Max Schep, Niels W. L. Brown, Vanessa Kraan, Gerald A. Gosens, Taco Polinder, Suzanne Ista, Erwin Verhaar, Jan A. N. Colaris, Joost W. The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults |
title | The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults |
title_full | The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults |
title_fullStr | The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults |
title_full_unstemmed | The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults |
title_short | The CAST study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults |
title_sort | cast study protocol: a cluster randomized trial assessing the effect of circumferential casting versus plaster splinting on fracture redisplacement in reduced distal radius fractures in adults |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059188/ https://www.ncbi.nlm.nih.gov/pubmed/33879131 http://dx.doi.org/10.1186/s12891-021-04238-0 |
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