Hand-2: Needle fasciotomy versus limited fasciectomy for treatment of Dupuytren’s contractures of fingers: a randomised non-inferiority trial with an individual participant data network meta-analysis comparison with DISC (ISRCTN18254597) to compare outcomes after collagenase injections

RESEARCH QUESTION What are the clinical and cost effectiveness of: a. needle fasciotomy (NF) compared to limited fasciectomy (LF) - Main Study b. NF compared to collagenase injections (CI) - Network Meta-Analysis in the treatment of Dupuytren’s contractures (DC)? BACKGROUND DC are common and impair hand function. Currently there is no high quality evidence to guide treatment. NF and LF are both used as standard care in the NHS, with choice of treatment often based on the surgeon’s preferences. Recently CI has been introduced as a treatment option and may have benefit over NF or LF. MAIN STUDY PRIMARY OBJECTIVE Is needle fasciotomy non-inferior to limited fasciectomy in terms of hand function 12 months post-treatment? SECONDARY OBJECTIVES To compare NF and LF for short-term recovery and at 24 months for: a. complication and re-operation rates b. health-related Quality of Life, healthcare resource use and cost effectiveness c. treatment acceptability (qualitative study) DESIGN (guided by Hand-1: Feasibility study): A pragmatic, multi-centre, two-arm, parallel, randomised non-inferiority trial comparing outcomes of needle fasciotomy and limited fasciectomy. There is an internal pilot phase which will review recruitment (10 months) and retention (18 months). SETTING: 12 UK NHS Trusts STUDY POPULATION: Adults referred to secondary care with Dupuytren’s contractures in an untreated finger that satisfies the NHS/CCG criteria for intervention and is suitable for treatment with either NF or LF. Adults with isolated DC of the distal interphalangeal joint, and those who are unable to adhere to trial procedures or complete questionnaires are excluded. PRIMARY OUTCOME • Part 2 of Patient Evaluation Measure (PEM) at 12 months post-treatment SECONDARY OUTCOMES • PROMS: MyMOP(2), SANE, EQ-5D-5L • restricted finger extension • adverse effects • NHS resource use • lost productivity and return to usual activities SAMPLE SIZE: 406 participants (203 per arm), recruited over 21 months from 12 sites. NETWORK META-ANALYSIS (NMA) WITH INDIVIDUAL PARTICIPANT DATA Hand-2 is designed to allow comparison of its outcomes with those of LF and CI in an ongoing NIHR study (DISC, ISRCTN18254597) PRIMARY OBJECTIVE To compare hand function 12 months after treatment with NF (Hand-2) and CI (DISC). SECONDARY OBJECTIVES To compare NF and CI for short-term recovery and, at 24 months: • complication and re-operation rates • healthcare resource use, Health-related Quality of Life and cost effectiveness. TIMELINE (months) 1-6 Trial set-up, finalise main study, meta-analysis protocols, approvals 7-12 Set-up 12 recruiting sites 8-16 Pilot recruitment 17 Review 1 - Review of recruitment 17-28 Full recruitment 25 Review 2 - Review of recruitment + retention 29-30 Complete final surgeries (average 2 month waiting time) 29-54 24 month Follow-up 54 Data cleaning and lock 55-60 Analysis, NMA + write-up IMPACT + DISSEMINATION The trial will determine whether NF produces non-inferior outcomes to LF and is cost-effective. The NMA will compare the outcomes and costs of CI, NF and LF. Both will inform the treatment of DC in the NHS. Study findings will be disseminated by HTA monograph, publications and presentations, and sent to guideline developers and health purchasers. The British Dupuytren’s Society (patient group) and BSSH will host lay summaries of the trial findings on their websites and use their social media outlets to disseminate them.