Dupuytren’s Interventions Surgery vs. Collagenase (DISC)
A pragmatic multi-centre randomised controlled non-inferiority, cost effectiveness trial comparing injections of collagenase into the cord to surgical correction in the treatment of moderate Dupuytren’s Contracture in adult patients.
University Hospitals of Leicester NHS Trust
Duration of Study in the UK
4 years, 5 months, 31 days
Is collagenase injection as effective as surgery for the treatment of moderate Dupuytren’s Contracture in adult patients?
Dupuytren’s Contracture is a common problem affecting the hand. The condition is caused by fibrous tissue, which forces the finger to bend down into the palm meaning patients cannot straighten their finger. The common treatment is surgery to remove the tissue and straighten the bent finger. A new treatment is a Collagenase injection, which softens the fibrous tissue. This is given in clinic, and is followed up in clinic a few days later where the finger is moved to help to straighten it.
Both treatments are offered on the NHS in England and are also used in the USA and Europe, but it is not known if the injection is as good as surgery at correcting the bent finger, if the correction continues in the long term and if the complication rates are similar. The study will also find out the cost of both treatments to see which is best value for money. We will also ask participants what they think about the different treatments, to see if they prefer one treatment more than the other.
In the study, adults with Dupytren’s contracture will receive an injection of Collagenase whilst others will receive surgery. The treatment people receive will be selected at random like tossing a coin (a randomised controlled trial). This means that two similar groups are created at the start, which will allow us to make unbiased conclusions from the study.
Over a 2 year period, participants will be seen at regular intervals for review and will also be asked to complete questionnaires about hand function.
Summary of Results:
The DISC Trial recruited 672 patients, who were equally and randomly assigned to have either surgery or collagenase injection. The study assessed whether the injection was as good and as safe as surgery at straightening the fingers, how long the fingers remained straightened, and if patient safety was similar between the treatments.
For up to two years after treatment, every participant’s hand function and general health were assessed. In one sub-study, some participants provided standardised photographs at set times, to monitor changes to their fingers (recurrence). In another, some were asked to express themselves freely and in more depth about their experiences of Dupuytren’s contracture and their treatments.
- Hand health improved following both treatments. Initially, the injection treatment improved hand health more than surgery. However, by the end of the first year after treatment, surgery improved hand health more than the injection treatment.
- Three-quarters of participants (78.4%) who received surgery reported complete straightening of the finger immediately after treatment compared to just over half of participants (61.6%) who received the injection.
- Recovery of hand function was however quicker for participants who received the injection, with recovery from surgery being slower.
- Participants who received the injection were more likely to see the finger begin to bend again (recurred) during the DISC Trial follow up – 17.2% of participants who received the injection reported this compared with 13.8% of participants who received surgery.
- Despite the faster initial benefits from injection, participants who received this were more likely to need further treatment at an earlier stage than those who received surgery.
- When considering these findings, many participants said that the less positive longer term outcome was acceptable for a better treatment experience.
- For both treatments, participants interviewed at three months after treatment, said they were happy with the hand improvement they experienced.
- More than half of all participants had no complications. Moderate or severe complications (i.e., those which may cause lasting problems occurred in 5% of participants who received surgery compared to 2% of participants who received the injection.
- The injection was good value for money at one year but by two years surgery was better value for money.
- Photographs taken by participants and evaluated by a medical expert, can help to monitor Dupuytren’s contracture recurrence, but do not give the same results as measurements taken in clinic.
Yorkshire & The Humber - Leeds West Research Ethics Committee
Date of REC Opinion
22 May 2017
Further Information Favourable Opinion