DupuytrEn Treatment EffeCtiveness Trial (DETECT): a protocol for prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of collagenase clostridium histolyticum, percutaneous needle fasciotomy and limited fasciectomy as short-term and long-term treatment strategies in Dupuytren's contracture

Abstract

Introduction: Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques.

Methods and analysis: We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50% improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed.

Ethics and dissemination: The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as published articles in peer-reviewed journals.

Trial registration number: NCT03192020; Pre-results.

Keywords: aponeurectomy; aponeurotomy; dupuytren disease; hand dysfunction; joint contracture; xiapex.

Figure 1

Four examples of possible scenarios in the different treatment strategy arms. *Success; **Success not achieved but patient does not want new treatment. CCH, collagenase clostridium histolyticum; LF, limited fasciectomy; PNF, percutaneous needle fasciotomy.

Figure 2

The assessment and treatment plan. *Clinically relevant progression is diagnosed in this trial when the patient contacts an outpatient clinic, because the disease has recurred or manifested in another finger (extension of disease) and the patient requests further treatment; that is, patient is not in a patient-accepted symptom state anymore, and at least 20° flexion contracture is observed. Note that the patient’s request for treatment is not limited to follow-up visits. The secondary treatment can be carried out whenever the patient requests it, but no sooner than 3 months after the primary intervention. **The patient will be treated with the same intervention as allocated primarily. However, the patient has right to refuse CCH or PNF and can request LF. If there is no palpable cord, the surgeon can decide to perform LF instead of CCH or PNF. CCH, collagenase clostridium histolyticum; LF, limited fasciectomy; PNF, percutaneous needle fasciotomy.