University Hospitals of Leicester NHS Trust, Leicester, UK.
York Trials Unit, University of York, York, UK.
Trials. 2021 Sep 30;22(1):671. doi: 10.1186/s13063-021-05595-w.
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.
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.
Clinical.Trials.gov ISRCTN18254597 . Registered on April 11, 2017.
掌腱膜挛缩症是一种影响超过 200 万英国成年人的手部纤维增生性疾病，尤其影响白种男性人群。手术是传统的治疗方法；然而，最近的研究表明，与安慰剂相比，另一种替代方法——胶原酶克利斯特里姆（胶原酶）——在治疗掌腱膜挛缩症方面更有效。然而，目前尚无强有力的随机对照试验能够明确回答胶原酶与有限的筋膜切开术相比的临床疗效。因此，设计了掌腱膜挛缩症干预手术与胶原酶试验（DISC）试验来填补这一证据空白。
方法/设计：DISC 试验是一项多中心实用的两臂平行组、随机对照试验。参与者将按照 1:1 的比例随机分配接受胶原酶注射或手术（有限筋膜切开术）。我们计划招募 710 名患有掌腱膜挛缩症的成年参与者。潜在参与者将在初级和二级保健中被识别，由授权临床医生进行筛查，如果符合条件并同意，将收集基线数据并完成随机分组。主要结局是治疗 1 年后的自我报告患者评估量表。次要结局指标包括法国风湿病学会手部疾病评估量表、密歇根手部问卷、EQ-5D-5L、资源利用、进一步的治疗程序、并发症、复发、总主动运动和伸展不足，以及恢复功能的时间。鉴于比较胶原酶注射和有限筋膜切开术复发率的有限证据，以及患者尽快恢复功能的重要性，将优先考虑与每种治疗方法相关的措施，以便评估在这些关键要素背景下的治疗效果。经济评估将评估治疗的成本效益，定性子研究将评估参与者对治疗的体验和偏好。
DISC 试验是我们所知的首个随机对照试验，旨在研究与有限的筋膜切开术相比，胶原酶治疗掌腱膜挛缩症的临床和成本效益。
Clinical.Trials.gov ISRCTN80067272，于 2017 年 4 月 11 日注册。
