Collagenase injection versus limited fasciectomy surgery to treat Dupuytren's contracture in adult patients in the UK: DISC, a non-inferiority RCT and economic evaluation.

Background: Dupuytren's contracture is caused by nodules and cords which pull the fingers towards the palm of the hand. Treatments include limited fasciectomy surgery, collagenase injection and needle fasciotomy. There is limited evidence comparing limited fasciectomy with collagenase injection. Objectives: To compare whether collagenase injection is not inferior to limited fasciectomy when treating Dupuytren's contracture. Design: Pragmatic, two-arm, unblinded, randomised controlled non-inferiority trial with a cost-effectiveness evaluation and nested qualitative and photographic substudies. Setting: Thirty-one National Health Service hospitals in England and Scotland. Participants: Patients with Dupuytren's contracture of ≥ 30 degrees who had not received previous treatment in the same digit. Interventions: Collagenase injection with manipulation 1-7 days later was compared with limited fasciectomy. Main outcome measures: The primary outcome was the Patient Evaluation Measure score, with 1 year after treatment serving as the primary end point. A difference of 6 points in the primary end point was used as the non-inferiority margin. Secondary outcomes included: Unité Rhumatologique des Affections de la Main scale; Michigan Hand Outcomes Questionnaire; recurrence; extension deficit and total active movement; further care/re-intervention; complications; quality-adjusted life-year; resource use; and time to function recovery. Randomisation and blinding: Online central randomisation, stratified by the most affected joint, and with variable block sizes allocates participants 1 : 1 to collagenase or limited fasciectomy. Participants and clinicians were not blind to treatment allocation. Results: Between 31 July 2017 and 28 September 2021, 672 participants were recruited ( Limitations: Impacts of the COVID-19 pandemic resulted in longer waits for Dupuytren's contracture treatment, meaning some participants could not be followed up for 2 years. This resulted in potential underestimation of Dupuytren's contracture recurrence and/or re-intervention rates, which may particularly have impacted the clinical effectiveness and long-term Markov model findings. Conclusions: Among adults with Dupuytren's contracture, collagenase delivered in an outpatient setting is less effective but more cost-saving than limited fasciectomy. Further research is required to establish the longer-term implications of both treatments. Future work: Recurrence and re-intervention usually occur after 1 year, and therefore follow-up to 5 years or more could resolve whether the differences observed in the Dupuytren's interventions surgery versus collagenase trial to 2 years worsen. Study registration: Current Controlled Trials ISRCTN18254597. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 15/102/04) and is published in full in