Condition category
Musculoskeletal Diseases
Date applied
19/08/2015
Date assigned
28/08/2015
Last edited
25/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dupuytren’s contracture is a condition that affects the hands and fingers, causing one or more fingers to gradually and irreversibly curl into the palm of the hand. Over time, this prevents the sufferer from being able to use the hand properly, making day to day tasks, such as grooming and shaking hands more difficult. It occurs when the connective tissue in the palm thickens, causing small hard lumps, called nodules, to develop under the skin of the palm. Over time, the nodules can develop to form cords of tissue that then shorten (contract) and pull a finger or thumb towards the palm. There are no agreed guidelines for the surgical treatment of this condition. However, 16,000 surgical procedures were performed in 2011-2012 costing the NHS £50 million. The most common operation is a “limited fasciectomy” (LF), which involves opening up the hand and removing the thickened cords causing the condition. It can be performed under general or regional anaesthesia and has a 4-6 week recovery period. A common alternative treatment is “needle fasciotomy” (NF), which involves inserting a fine needle into the thickened cords to divide them under the skin and release the tightness in the hand. This is performed under local anaesthesia in a clinic room and has a 1-2 week recovery period. The Dupuytren's contracture comes back more commonly after needle fasciotomy than after limited fasciectomy. Little information is available about patient reported outcomes to assess the recovery after Dupuytren’s treatment. A study to compare the outcomes and costs of these two treatments is therefore needed. Here, we are going to run a smaller feasibility study in order to help with planning of the main study.

Who can participate?
Adults (aged at least 18) with Dupuytren’s contracture.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have a needle fasciotomy. Those in group 2 have a limited fasciotomy. All participants are then seen on two occasions following their treatment and are also be asked to complete questionnaires at home. Participants may be asked to take part in qualitative interviews for us to understand reasons for trial participation and explore patients’ experiences of the trial and acceptability of the treatments. Members of staff who are recruiting patients to the study may also be interviewed to identify possible recruitment difficulties. The trial takes place over 22 months.

What are the possible benefits and risks of participating?
Taking part in this study may not help the participants directly, but it should help improve future care for patients with Dupuytren’s contracture. Both the treatments are available as routine NHS care, so there is no extra risk involved in receiving them as part of the study. For participants taking part in if in the optional interviews, it is possible that talking about their feelings and other issues related to their diagnosis and treatment may cause anxiety, but they are able to pause or finish the discussion with the researcher at any time.

Where is the study run from?
Three NHS Secondary care hospitals in England (UK)

When is the study starting and how long is it expected to run for?
October 2015 to September 2016

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Eleanor Harrison

Trial website

www.nottingham.ac.uk/hand1

Contact information

Type

Scientific

Primary contact

Mrs Eleanor Harrison

ORCID ID

http://orcid.org/0000-0003-0652-3980

Contact details

University of Nottingham
Queens Medical Centre
Derby Road
Nottingham
Nottinghamshire
NG7 2UH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19243

Study information

Scientific title

Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers: a feasibility study which investigates the acceptability and design of a multicentre randomised controlled trial (RCT)

Acronym

HAND-1

Study hypothesis

The aim of this study is to evaluate the feasibility of conducting a randomised controlled trial comparing two surgical treatments (needle fasciotomy and limited fasciectomy) for Dupuytren's contracture.

Ethics approval

15/EM/0197

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

1. Needle fasciotomy - This procedure takes place in an outpatient clinic room setting. The contracture is divided with a needle which pierces the skin (no skin incision)
2. Limited fasciectomy - This procedure takes place in an operating theatre under regional or general anaesthesia. The contracture is surgically removed via an incision

Intervention type

Other

Phase

Drug names

Primary outcome measures

Multi outcomes; Timepoint(s): baseline, Day of surgery, 2 weeks post-surgery, 6 weeks post-surgery and 6 months post-surgery

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2015

Overall trial end date

30/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years.
2. One or more fingers with a Dupuytren’s contracture of >30° in the metacarpophalangeal (MCP) and/or proximal
interphalangeal joints (PIP).
3. Well defined cord(s) causing contracture.
4. No previous surgery for Dupuytren’s contracture on the same hand.
5. Willing to undergo either study procedure.
6. Able to complete follow up assessments.; Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Dupuytren's contracture of the distal interphalangeal joints (DIP) only
2. Planned dermofasciectomy or very limited fasciectomy (excision of =1cm cord segment)
3. Previously recruited into this study for treatment of either hand
4. Life expectancy less than 3 years

Recruitment start date

03/11/2015

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Nottingham
Queens Medical Centre Derby Road
Nottingham, Nottinghamshire
NG7 2UH
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Rd
Derby
DE22 3NE
United Kingdom

Trial participating centre

Wrightington Hospital
Hall Ln Appley Bridge
Wigan
WN6 9EP
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust

Sponsor details

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute of Health Research; Grant Codes: PB-PG-0613-31083

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

25/10/2016: Recruitment start date changed from 01/10/2015 to 03/11/2015 30/09/2016: Added acronym to record, added trial website information, added study contact ORCID. Added two trail participating centres. Changed overall trial start date from 01/10/2015 to 01/07/2015. Changed overall trial end date from 30/09/2016 to 30/07/2017