Purpose The purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures. Design The design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention. Participants Patients aged 18 years or over who were referred from primary to secondary care for treatment of a hand with Dupuytren's contractures of one or more fingers of more than 30° at the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints and well-defined cord(s). Patients were excluded if they had undergone previous Dupuytren's contracture surgery on the same hand. Methods Potential participants were screened for eligibility. Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment. Data on recruitment rates, completion of follow-up, and procedure costs were collected. Four patient reported outcome measures (PROMs) and objective outcome measures were collected before intervention and 6 weeks and 6 months afterwards. Results One hundred and fifty-three of 267 (57%) primary-care referrals for Dupuytren's contractures met the eligibility criteria for the study. Seventy-one of the 153 (46%) agreed to participate and were randomly allocated to treatment with needle fasciotomy or limited fasciectomy. Sixty-seven of these underwent their allocated treatment, two were crossovers from limited fasciectomy to needle fasciotomy, and two (both allocated limited fasciectomy) received no treatment. Fifty-nine participants (85%) completed 6-month follow-up PROMs. Participants felt the MYMOP, PEM and URAM PROMs allowed them to better describe how their treatment affected their hand function than the DASH PROM. The estimated costs of limited fasciectomy (in an operating theatre) and needle fasciotomy (in a clinic room) were £777 and £111 respectively. Conclusion A large RCT comparing treatment of Dupuytren's contractures by needle fasciotomy and limited fasciectomy is feasible. Data from this study will help determine the number of sites and duration of recruitment required to complete an adequately powered RCT and will assist the selection of PROMs in future studies on the treatment of Dupuytren's contractures. (Level 1 feasibility study). Trial registration Trial registered with ISRCTN (registration number: ISRCTN11164292), date assigned - 28/08/2015.

中文翻译：

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一项比较针筋膜切开术与有限筋膜切除术治疗 Dupuytren 挛缩的随机可行性试验。

目的 本研究的目的是评估进行一项大型、多中心随机对照试验 (RCT) 的可行性，该试验比较针状筋膜切开术与有限筋膜切除术治疗 Dupuytren 挛缩。设计 本研究的设计是一项平行、两臂、多中心、随机可行性试验，采用嵌入式 QuinteT 招募干预。参与者 18 岁或以上的患者从初级保健转诊到二级保健，以治疗一只或多根手指在掌指 (MCP) 和/或近端指间 (PIP) 关节处的 Dupuytren 挛缩超过 30° - 定义的绳索。如果患者曾在同一只手上接受过 Dupuytren 挛缩手术，则他们被排除在外。方法 筛选潜在参与者的资格。招募的参与者随机 (1:1) 接受针状筋膜切开术或有限筋膜切除术治疗，并在治疗后随访长达 6 个月。收集了有关招募率、完成随访和手术费用的数据。在干预前和干预后 6 周和 6 个月收集了四名患者报告的结果测量 (PROM) 和客观结果测量。结果 267 名 (57%) 的 Dupuytren 挛缩初级保健转诊中有 153 名符合研究的资格标准。153 人中有 71 人（46%）同意参加，并被随机分配接受针状筋膜切开术或有限筋膜切除术治疗。其中 67 人接受了分配治疗，其中 2 人是从有限筋膜切除术过渡到针状筋膜切开术，两个（均分配有限的筋膜切除术）未接受任何治疗。59 名参与者 (85%) 完成了 6 个月的随访 PROM。参与者认为 MYMOP、PEM 和 URAM PROM 让他们能够比 DASH PROM 更好地描述他们的治疗如何影响他们的手部功能。有限筋膜切除术（在手术室）和针状筋膜切开术（在诊所）的估计费用分别为 777 英镑和 111 英镑。结论 一项比较针筋膜切开术和有限筋膜切除术治疗 Dupuytren 挛缩的大型 RCT 是可行的。这项研究的数据将有助于确定完成充分有力的 RCT 所需的站点数量和招募持续时间，并将有助于在未来关于治疗 Dupuytren 挛缩的研究中选择 PROM。（一级可行性研究）。