A feasibility study of treatments for Dupuytren's Contracture
Research type
Research Study
Full 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).
IRAS ID
169451
Contact name
Maria Koufali
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Clinicaltrials.gov Identifier
NIHR - RfPB, PB-PG-0613-31083
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
Dupuytren’s contracture is a condition causing one or more finger(s) to gradually and irreversibly curl into the palm, resulting in loss of hand function of day-to day tasks such as washing, grooming and shaking hands. There are no agreed guidelines for the surgical treatment of this condition yet 16,000 procedures were performed in 2011-2012 costing the NHS £50 million. The most common operation is a “limited fasciectomy” (LF), which is done under general/regional anaesthesia in an operating theatre and has a 4-6 week recovery period. A common alternative treatment is “needle fasciotomy” (NF) which is done 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 large randomised trial is needed to compare the outcomes and cost of these two treatments. However before this can be done a feasibility study is required in order to help with planning a larger study. This feasibility study has been funded by the National Institute for Health Research (NIHR) and 50-85 patients will be recruited from 3 NHS Secondary care hospitals in England. Participants with Dupuytren’s contracture will be randomly allocated to receive one of two treatments, will be seen on two occasions following their treatment and will 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 will take place over 22 months.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0197
Date of REC Opinion
22 May 2015
REC opinion
Further Information Favourable Opinion