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A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomi

Harrison, Eleanor; Tan, Wei; Mills, Nicola; Karantana, Alexia; Sprange, Kirsty; Duley, Lelia; Elliott, Daisy; Blazeby, Jane M.; Hollingworth, William; Montgomery, Alan A.; Davis, Tim

Authors

Eleanor Harrison

Wei Tan

Nicola Mills

Alexia Karantana alexiak41@hotmail.com

Kirsty Sprange

Lelia Duley lelia.duley@nottingham.ac.uk

Daisy Elliott

Jane M. Blazeby

William Hollingworth

Alan A. Montgomery

Tim Davis



Abstract

© 2017 The Author(s). Background: Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment within the NHS is surgery to remove (fasciectomy) or divide (fasciotomy) the contractures, and the treatment offered is frequently determined by surgeon preference. This study aims to determine the feasibility of conducting a large, multicentre randomised controlled trial to assess the clinical and cost-effectiveness of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contracture. Methods/design: HAND-1 is a parallel, two-arm, multicentre, randomised feasibility trial. Eligible patients aged 18 years or over who have one or more fingers with a Dupuytren's contracture of more than 30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints, well-defined cord(s) causing contracture, and have not undergone previous surgery for Dupuytren's on the same hand will be randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy. Participants will be followed-up for up to 6 months post surgery. Feasibility outcomes include number of patients screened, consented and randomised, adherence with treatment, completion of follow-up and identification of an appropriate patient-reported outcome measure (PROM) to use as primary outcome for a main trial. Embedded qualitative research, incorporating a QuinteT Recruitment Intervention, will focus on understanding and optimising the recruitment process, and exploring patients' experiences of trial participation and the interventions. Discussion: This study will assess whether a large multicentre trial comparing the clinical and cost-effectiveness of needle fasciotomy and limited fasciectomy for the treatment of Dupuytren's contractures is feasible, and if so will provide data to inform its design and successful conduct. Trial registration: International Standard Registered Clinical/soCial sTudy Number: ISRCTN11164292. Registered on 28 August 2015.

Journal Article Type Article
Publication Date Aug 25, 2017
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 18
Issue 1
Article Number 392
APA6 Citation Harrison, E., Tan, W., Mills, N., Karantana, A., Sprange, K., Duley, L., …Davis, T. (2017). A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): Study protocol for a randomised controlled trial. Trials, 18(1), https://doi.org/10.1186/s13063-017-2127-9
DOI https://doi.org/10.1186/s13063-017-2127-9
Keywords Dupuytren’s contracture; Needle fasciotomy; Limited fasciectomy; Randomised controlled trial; Feasibility; Patient-reported outcome measure
Publisher URL https://doi.org/10.1186/s13063-017-2127-9
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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