Simon Toftgaard Skov1, Therkel Bisgaard2, Per Søndergaard2, Jeppe Lange3. 1. Interdisciplinary Research Unit, Center for Planned Surgery, Silkeborg, Denmark; Orthopaedic Research Laboratory, Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark. Electronic address: simon.skov@clin.au.dk. 2. Center for Planned Surgery, Regional Hospital Silkeborg, Silkeborg, Denmark. 3. Interdisciplinary Research Unit, Center for Planned Surgery, Silkeborg, Denmark; Orthopaedic Research Unit, Department of Orthopaedic Surgery, Aarhus University Hospital, Aarhus, Denmark.
Abstract
PURPOSE:Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren contracture with more than 1-year follow-up, despite a wide and increasing clinical use. METHOD: In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in contracture by 50% or more relative to baseline. Secondary outcomes included change in contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score. RESULTS: Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed. CONCLUSIONS: This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and it led to more complications than PNF. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.
RCT Entities:
PURPOSE: Collagenase Clostridium histolyticum (CCH) injection was introduced commercially as a treatment for Dupuytren contracture following initial phase-3 investigations in 2009 with promising results. However, the efficacy of CCH has not been prospectively investigated in a direct comparison to other active treatments of Dupuytren contracture with more than 1-year follow-up, despite a wide and increasing clinical use. METHOD: In this prospective, independent, open-label, randomized controlled trial, (Clinicaltrials.gov; NCT 01538017), percutaneous needle fasciotomy (PNF) was directly compared with CCH. Fifty patients with primary isolated proximal interphalangeal joint Dupuytren contractures were enrolled and followed for 2 years. The primary outcome was clinical improvement defined as a reduction in contracture by 50% or more relative to baseline. Secondary outcomes included change in contracture, recurrence, adverse events, complications, and Disabilities of the Arm, Shoulder, and Hand questionnaire score. RESULTS: Clinical improvement at 2 years was maintained in 7% of CCH patients (2 of 29) and 29% of PNF patients (6 of 21). Collagenase Clostridium histolyticum led to more, mainly transient, complications, in 93% of patients versus 24% of the patients treated with PNF. No other differences were observed. CONCLUSIONS: This study provides evidence that CCH is not superior to PNF in the treatment of isolated proximal interphalangeal joint Dupuytren contracture regarding clinical outcome, and it led to more complications than PNF. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic I.
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