A protocol for the conduct of a multicentre, prospective, randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures.
Journal
Bone & joint open
ISSN: 2633-1462
Titre abrégé: Bone Jt Open
Pays: England
ID NLM: 101770336
Informations de publication
Date de publication:
22 Apr 2024
22 Apr 2024
Historique:
medline:
22
4
2024
pubmed:
22
4
2024
entrez:
21
4
2024
Statut:
epublish
Résumé
Fractures of the humeral shaft represent 3% to 5% of all fractures. The most common treatment for isolated humeral diaphysis fractures in the UK is non-operative using functional bracing, which carries a low risk of complications, but is associated with a longer healing time and a greater risk of nonunion than surgery. There is an increasing trend to surgical treatment, which may lead to quicker functional recovery and lower rates of fracture nonunion than functional bracing. However, surgery carries inherent risk, including infection, bleeding, and nerve damage. The aim of this trial is to evaluate the clinical and cost-effectiveness of functional bracing compared to surgical fixation for the treatment of humeral shaft fractures. The HUmeral SHaft (HUSH) fracture study is a multicentre, prospective randomized superiority trial of surgical versus non-surgical interventions for humeral shaft fractures in adult patients. Participants will be randomized to receive either functional bracing or surgery. With 334 participants, the trial will have 90% power to detect a clinically important difference for the Disabilities of the Arm, Shoulder and Hand questionnaire score, assuming 20% loss to follow-up. Secondary outcomes will include function, pain, quality of life, complications, cost-effectiveness, time off work, and ability to drive. The results of this trial will provide evidence regarding clinical and cost-effectiveness between surgical and non-surgical treatment of humeral shaft fractures. Ethical approval has been obtained from East of England - Cambridge Central Research Ethics Committee. Publication is anticipated to occur in 2024.
Identifiants
pubmed: 38643977
doi: 10.1302/2633-1462.54.BJO-2023-0151.R1
pii: BJO-2023-0151.R1
doi:
Types de publication
Journal Article
Langues
eng
Pagination
343-349Subventions
Organisme : National Institute for Health and Care Research
Informations de copyright
© 2024 Franssen et al.
Déclaration de conflit d'intérêts
J. Achten and M. L. Costa report institutional funding from NIHR and the Wellcome Trust for research into musculoskeletal trauma, unrelated to this study. A. Rangan reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events, and support for attending meetings and/or travel from DePuy Johnson & Johnson, unrelated to this study.
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