A feasibility study of treatments for Dupuytren's contracture (HAND-1)
| ISRCTN | ISRCTN11164292 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11164292 |
| Secondary identifying numbers | 19243 |
- Submission date
- 19/08/2015
- Registration date
- 28/08/2015
- Last edited
- 06/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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. This is a smaller feasibility study 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
Contact information
Scientific
University of Nottingham
Queens Medical Centre
Derby Road
Nottingham, Nottinghamshire
NG7 2UH
United Kingdom
 ORCID ID |
0000-0003-0652-3980 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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) |
| Study 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(s) | 15/EM/0197 |
| 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 |
| Primary outcome measure | 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 study start date | 01/07/2015 |
| Overall study end date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 50; UK Sample Size: 50 |
| Total final enrolment | 71 |
| 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 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
- England
- United Kingdom
Study participating centres
Derby Road
Nottingham, Nottinghamshire
NG7 2UH
United Kingdom
Derby
DE22 3NE
United Kingdom
Appley Bridge
Wigan
WN6 9EP
United Kingdom
Sponsor information
Hospital/treatment centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
"ROR" |
https://ror.org/05y3qh794 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/08/2017 | Yes | No | |
| Results article | results | 30/01/2020 | 06/02/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/02/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
19/10/2017: Publication reference added.
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
