Evidence map›Paper›PMID 32021696›Full record

ArticlePilot and feasibility studies2020

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

T R C Davis, W Tan, E F Harrison, W Hollingworth, A Karantana, N Mills, T Hepburn, K Sprange, L Duley, J M Blazeby and 4 more

Open access · goldAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 26% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
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

14 authors at 4 institutions in 1 country.

T R C Davis1Nottingham University Hospitals NHS Trust, Queen's Medical Centre, Derby Road, Nottingham, NG7 2UH UK.ORCID 0000-0001-5729-6680
W Tan2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.
E F Harrison2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.
W Hollingworth3Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
A Karantana4Centre for Evidence Based Hand Surgery, Academic Orthopaedics Trauma and Sports Medicine, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
N Mills3Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
T Hepburn2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.
K Sprange2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.
L Duley2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.
J M Blazeby3Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.
C G Bainbridge5Derby Teaching Hospitals NHS Foundation Trust, Uttoxeter Road, Derby, DE22 3NE UK.
S R Murali6Wrightington, Wigan and Leigh NHS Foundation Trust, Hall Lane, Appley Bridge, Wigan, Lancashire WN6 9EP UK.
A A Montgomery2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.
HAND-1 Study group
University of Nottingham · GBNottingham University Hospitals NHS Trust · GBUniversity of Bristol · GBWrightington, Wigan and Leigh NHS Foundation Trust · GB

Funding

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

Abstract

purposeThe 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.

designThe design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention.

participantsPatients 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.

methodsPotential 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.

resultsOne 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.

conclusionA 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).

trial registrationTrial registered with ISRCTN (registration number: ISRCTN11164292), date assigned - 28/08/2015.

Indexed as

Dupuytren’s contractureFeasibilityLimited fasciectomyNeedle fasciotomyRandomised trial

Identifiers

PMID32021696
PMCPMC6993423
OpenAlexW3007958866

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.