Dupuytren’s Interventions Surgery versus Collagenase (DISC) Trial:Study Protocol for a pragmatic, two arm parallel group, non-inferiority randomised controlled trial

Background: Dupuytren’s contracture is a fibro-proliferative disease of the hands affecting over 2 million UK adults, particularly the white, male population. Surgery is the traditional treatment, however recent studies have indicated that an alternative to surgery - Collagenase Clostridium Histolyticum (Collagenase) - is better than placebo in the treatment of Dupuytren’s contracture. There is however no robust randomised controlled trial that provides a definitive answer on the clinical effectiveness of Collagenase compared with limited fasciectomy surgery. The Dupuytren’s Interventions Surgery vs Collagenase Trial (DISC) Trial was therefore designed to fill this evidence gap. Methods/Design: The DISC Trial is a multi-centre pragmatic two arm parallel group, randomised controlled trial. Participants will be assigned 1:1 to receive either Collagenase injection or surgery (limited fasciectomy). We aim to recruit 710 adult participants with Dupuytren’s contracture. Potential participants will be identified in primary and secondary care, screened by a delegated clinician and if eligible and consenting, baseline data will be collected and randomisation completed. The primary outcome will be the self-reported Patient Evaluation Measure assessed at 1 year after treatment. Secondary outcome measures include the Unité Rhumatologique des Affections de la Main Scale, the Michigan Hand Questionnaire, EQ-5D-5L, resource use, further procedures, complications, recurrence, total active movement and extension deficit, and time to return to function. Given the limited evidence comparing recurrence rates following Collagenase injection and limited fasciectomy, and the importance of a return to function as soon as possible for patients, the associated measures for each will be prioritised to allow treatment effectiveness in the context of these key elements to be assessed. An economic evaluation will assess the cost effectiveness of treatments and a qualitative sub-study will assess participants experiences and preferences of the treatments. Discussion: The DISC trial is the first randomised controlled trial, to our knowledge, to investigate the clinical and cost effectiveness of Collagenase compared to limited fasciectomy surgery for patients with Dupuytren’s contracture. ISRCTN registry identifier: ISRCTN18254597. Prospectively registered on 11th April 2017. https://doi.org/10.1186/ISRCTN18254597 Keywords: Dupuytren’s contracture, Collagenase clostridium histolyticum, limited fasciectomy, surgery, correction, randomised controlled trial