Abstract
PurposeThe 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.DesignThe design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention.ParticipantsPatients 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.MethodsPotential 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.ResultsOne 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.ConclusionA 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 registrationTrial registered with ISRCTN (registration number: ISRCTN11164292), date assigned - 28/08/2015.
Highlights
Needle fasciotomy (NF) and limited fasciectomy (LF) are established surgical treatments offered to patients with Dupuytren’s contractures of the fingers
NF can be undertaken in a clinic room and has a short recovery period, whereas LF is performed in an operating theatre and has a longer recovery period
Seven cases were excluded as the surgeon considered them unsuitable for treatment by either NF or LF
Summary
Needle fasciotomy (NF) and limited fasciectomy (LF) are established surgical treatments offered to patients with Dupuytren’s contractures of the fingers. A systematic review of surgery for Dupuytren’s contracture [1] found one small randomised controlled trial (RCT) comparing these treatments, which showed that LF corrects contractures better [2] and has a lower recurrence contracture rate [3] than NF. The systematic review highlighted that the primary outcome of most existing studies is based on angular deformity of the finger joints. Though popular with health professionals, this is not a good surrogate for hand function as it does not consider the impact of treatment complications, such as finger numbness, loss of flexion and pain, on hand function [1]. Patient-centred studies, which assess function using appropriate, relevant Patient-Reported Outcome Measures (PROMs), are required to guide day-to-day clinical practice
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