Evidence map›Paper›PMID 28841903›Full record

Trial reportTrials2017

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.

Eleanor Harrison, Wei Tan, Nicola Mills, Alexia Karantana, Kirsty Sprange, Lelia Duley, Daisy Elliott, Jane Blazeby, William Hollingworth, Alan A Montgomery and 1 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.5field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Eleanor HarrisonNottingham Clinical Trials Unit, University of Nottingham, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Wei TanNottingham Clinical Trials Unit, University of Nottingham, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Nicola MillsSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Alexia KarantanaDepartment of Academic Orthopaedics, Trauma and Sports Medicine, School of Medicine, University of Nottingham, Nottingham, NG7 2UH, UK.
Kirsty SprangeNottingham Clinical Trials Unit, University of Nottingham, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Lelia DuleyNottingham Clinical Trials Unit, University of Nottingham, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Daisy ElliottSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Jane BlazebySchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
William HollingworthSchool of Social and Community Medicine, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
Alan A MontgomeryNottingham Clinical Trials Unit, University of Nottingham, C Floor, South Block, Queen's Medical Centre, Nottingham, NG7 2UH, UK.
Tim DavisQueen's Medical Centre, Nottingham University Hospitals NHS Trust, Derby Road, Nottingham, NG7 2UH, UK. Tim.Davis@nuh.nhs.uk.
University of Bristol · GBUniversity of Nottingham · GBQueen's Medical Centre · GB

Funding

Department of Health PB-PG-0613-31083Medical Research Council MR/K025643/1
6 · The paper itself

Abstract

backgroundDupuytren'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/

designHAND-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 registrationInternational Standard Registered Clinical/soCial sTudy Number: ISRCTN11164292 . Registered on 28 August 2015.

Indexed as

Clinical ProtocolsCost-Benefit AnalysisDupuytren ContractureEnglandFasciotomyFeasibility StudiesHealth Care CostsHumansNeedlesPatient Reported Outcome MeasuresResearch DesignTime FactorsTreatment OutcomeDupuytren’s contractureFeasibilityLimited fasciectomyNeedle fasciotomyPatient-reported outcome measureRandomised controlled trial

Identifiers

PMID28841903
PMCPMC5574125
OpenAlexW2747648984

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.