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A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures

the HAND-1 Study group; Davis, T. R. C.; Tan, W.; Harrison, E. F.; Hollingworth, W.; Karantana, A.; Mills, N.; Hepburn, T.; Sprange, K.; Duley, L.; Blazeby, J. M.; Bainbridge, C. G.; Murali, R; Montgomery, A. A.

A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren’s contractures Thumbnail


Authors

the HAND-1 Study group

T. R. C. Davis

W. Tan

W. Hollingworth

ALEXIA KARANTANA ALEXIA.KARANTANA@NOTTINGHAM.AC.UK
Clinical Associate Professor in Hand Surgery

N. Mills

TRISH HEPBURN Trish.Hepburn@nottingham.ac.uk
Senior Medical Statistician

L. Duley

J. M. Blazeby

C. G. Bainbridge

R Murali

ALAN MONTGOMERY ALAN.MONTGOMERY@NOTTINGHAM.AC.UK
Director Nottingham Clinical Trials Unit



Abstract

© 2020 The Author(s). Purpose: The purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures. Design: The design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention. Participants: Patients aged 18 years or over who were referred from primary to secondary care for treatment of a hand with Dupuytren's contractures of one or more fingers of more than 30° at the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints and well-defined cord(s). Patients were excluded if they had undergone previous Dupuytren's contracture surgery on the same hand. Methods: Potential participants were screened for eligibility. Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment. Data on recruitment rates, completion of follow-up, and procedure costs were collected. Four patient reported outcome measures (PROMs) and objective outcome measures were collected before intervention and 6 weeks and 6 months afterwards. Results: One hundred and fifty-three of 267 (57%) primary-care referrals for Dupuytren's contractures met the eligibility criteria for the study. Seventy-one of the 153 (46%) agreed to participate and were randomly allocated to treatment with needle fasciotomy or limited fasciectomy. Sixty-seven of these underwent their allocated treatment, two were crossovers from limited fasciectomy to needle fasciotomy, and two (both allocated limited fasciectomy) received no treatment. Fifty-nine participants (85%) completed 6-month follow-up PROMs. Participants felt the MYMOP, PEM and URAM PROMs allowed them to better describe how their treatment affected their hand function than the DASH PROM. The estimated costs of limited fasciectomy (in an operating theatre) and needle fasciotomy (in a clinic room) were £777 and £111 respectively. Conclusion: A large RCT comparing treatment of Dupuytren's contractures by needle fasciotomy and limited fasciectomy is feasible. Data from this study will help determine the number of sites and duration of recruitment required to complete an adequately powered RCT and will assist the selection of PROMs in future studies on the treatment of Dupuytren's contractures. (Level 1 feasibility study).

Journal Article Type Article
Acceptance Date Dec 20, 2019
Online Publication Date Jan 30, 2020
Publication Date Jan 30, 2020
Deposit Date Jan 6, 2020
Publicly Available Date Feb 5, 2020
Journal Pilot and Feasibility Studies
Electronic ISSN 2055-5784
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 6
Issue 1
Article Number 7
DOI https://doi.org/10.1186/s40814-019-0546-y
Public URL https://nottingham-repository.worktribe.com/output/3674629
Publisher URL https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0546-y
Additional Information Received: 20 August 2019; Accepted: 20 December 2019; First Online: 30 January 2020; : Approval was by the East Midlands—Derby Research Ethics Committee (Ref: CitationRef removed/EM/0197).; : Not applicable.; : The authors declare that they have no competing interests.

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