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01.12.2017 | Study protocol | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Eleanor Harrison, Wei Tan, Nicola Mills, Alexia Karantana, Kirsty Sprange, Lelia Duley, Daisy Elliott, Jane Blazeby, William Hollingworth, Alan A. Montgomery, Tim Davis
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-2127-9) contains supplementary material, which is available to authorized users.

Abstract

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.
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