Hand-2: RCT of treatments for Dupuytren’s contractures
Research type
Research Study
Full title
Hand-2: Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers: a randomised, multi-centre non-inferiority trial
IRAS ID
282087
Contact name
Tim Davis
Contact email
Sponsor organisation
Nottingham University Hospitals Trust
ISRCTN Number
ISRCTN12525655
Duration of Study in the UK
5 years, 1 months, 1 days
Research summary
Dupuytren’s contractures (DC) are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to gradually and irreversibly curl into the palm, resulting in loss of hand function for day-to-day tasks such as washing, grooming and shaking hands. The most common operation is a “limited fasciectomy” (LF), which is done under general 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 12 week recovery period. Compared with LF, NF is less expensive for the NHS, less disruptive for patients, and probably carries a lower risk of complications that restrict hand function. The DC comes back more commonly after NF than after LF.
The aim of the study is to determine whether NF is not worse than LF at preserving hand function and which treatment offers best value for money. An integrated QuinteT Recruitment Intervention will be used to optimise recruitment in Hand-2. The recruitment target is 406 participants over 21 months from 12 NHS Secondary care hospitals in England. Participants will be randomly allocated to have either NF or LF treatment and seen on one occasion following their treatment and will also be asked to complete questionnaires at home. Participants may take part in qualitative interviews for us to understand reasons for participation and explore experiences of the study. Members of staff who are recruiting to the study may also be interviewed to identify any issues.
Results will be shared with a research team comparing LF with a third treatment option, collagenase injections, in another study funded by NIHR (DISC; ISRCTN18254597). This will provide even more information on how best to treat DC.
REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0911
Date of REC Opinion
8 Sep 2020
REC opinion
Further Information Favourable Opinion