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 a 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. Dupuytren’s intervention 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 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. Trial registration Clinical.Trials.gov ISRCTN18254597. Registered on April 11, 2017.

Serious complications and risk of re-operation after Dupuytren’s disease surgery: a population-based cohort study of 121,488 patients in England

Dupuytren’s disease (DD) is a common fibro-proliferative disorder of the palm. We estimated the risk of serious local and systemic complications and re-operation after DD surgery. We queried England’s Hospital Episode Statistics database and included all adult DD patients who were surgically treated. A longitudinal cohort study and self-controlled case series were conducted. Between 1 April 2007 and 31 March 2017, 121,488 adults underwent 158,119 operations for DD. The cumulative incidence of 90-day serious local complications was low at 1.2% (95% CI 1.1–1.2). However, the amputation rate for re-operation by limited fasciectomy following dermofasciectomy was 8%. 90-day systemic complications were also uncommon at 0.78% (95% CI 0.74–0.83), however operations routinely performed under general or regional anaesthesia carried an increased risk of serious systemic complications such as myocardial infarction. Re-operation was lower than previous reports (33.7% for percutaneous needle fasciotomy, 19.5% for limited fasciectomy, and 18.2% for dermofasciectomy). Overall, DD surgery performed in England was safe; however, re-operation by after dermofasciectomy carries a high risk of amputation. Furthermore, whilst serious systemic complications were unusual, the data suggest that high-risk patients should undergo treatment under local anaesthesia. These data will inform better shared decision-making regarding this common condition.

RANDOMIZED CONTROLLED TRIAL OF LIMITED FASCIECTOMY WITH INJECTION OF ADIPOSE GRAFT FOR DUPUYTREN’S DISEASE

ABSTRACT Objective: Dupuytren’s disease is a genetic disorder related to the proliferation of myofibroblasts. The pluripotent property of stem cells present in adipose tissue inhibits myofibroblast proliferation. Our study sought to evaluate the effect of stem cell-rich fat grafts in patients that underwent limited fasciectomy. Methods: We studied 45 patients, in a single-blind, prospective, randomized clinical trial. All patients underwent limited fasciectomy. In one group, fat graft was injected. Results: The total passive extension deficit results did not exhibit a significant difference. Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up. Conclusion: Fat grafting associated with limited fasciectomy promotes worse functional results compared to conventional limited fasciectomy in the short term. However, long-term results and recurrence rates should be further assessed. Level of Evidence II, Prospective comparative study.

Patient’s satisfaction beyond hand function in Dupuytren’s disease: analysis of 1106 patients

This study investigates the outcomes of 1106 patients with Dupuytren’s disease treated with limited fasciectomy or percutaneous needle fasciotomy over 16 years according to the different domains of patient-reported hand function. These patients completed the Michigan Hand Outcomes Questionnaire before and 3 months after surgery. Scores for the various outcome parameters were calculated and linear regression analyses were used to examine associations between the changes in digital extension deficit and change in Michigan Hand Outcomes Questionnaire (sub)scores. We found the largest effects of surgical treatment in the decreases in extension deficit, the appearance of the hand, and the satisfaction with the hand function. However, associations between different domains of evaluation were weak. We conclude that improvement of digital extension deficits is not parallel to varying aspects of patient satisfaction. The findings underline the importance of assessing domains relating to patient satisfaction other than objective hand function measures in Dupuytren’s disease. Level of evidence: IV