Collagenase Clostridium histolyticum Versus Needle Fasciotomy for Primary Metacarpophalangeal Dupuytren Contracture: Five-Year Results from a Randomized Controlled Trial.

Abstract

Background: Collagenase Clostridium histolyticum (CCH) and percutaneous needle fasciotomy (PNF) are 2 treatment options for Dupuytren disease. The purpose of this study was to compare these 2 methods in terms of clinical and patient-reported outcomes.

Methods: Eighty patients (median age, 72 years; 83% male) with a single-digit primary metacarpophalangeal (MCP) joint contracture of ≥30° were randomized to either CCH or PNF and followed for 5 years. The primary outcome was the difference in flexion-contracture reduction at the MCP joint from baseline to 2 years, with additional analysis examining the effect of the primary endpoint variable up to 5 years. Secondary outcomes included complications, grip strength, scores on the visual analogue scale (VAS) for pain, the shortened version of the Disabilities of the Arm, Shoulder and Hand, the brief Michigan Hand Questionnaire, Unité Rhumatologique des Affections de la Main, and a VAS for treatment satisfaction as well as recurrence and retreatments.

Results: The mean MCP joint contracture was 48° at baseline and 2° at 5 years in the CCH group, and 50° at baseline and 7° at 5 years in the PNF group. The reduction in MCP contracture at 2 years was larger in the CCH group than in the PNF group, with a mean difference between the groups of 12° (95% confidence interval [CI], 1.5° to 22.3°; p = 0.026). At 5 years, this mean difference was reduced to 6° (-1.5° to 12.8°; p = 0.1). There was no difference between the groups in any patient-reported outcome scores or grip strength beyond 4 weeks, with the exception of the brief Michigan Hand Questionnaire at 5 years. Ten (25%) of the patients in the PNF group compared with no patient in the CCH group had recurrence (contracture of ≥30°) at the MCP joint at 2 years. At 5 years, 17 (42.5%) of 40 patients in the PNF group had been retreated compared with 4 (10%) of 40 in the CCH group (p < 0.001). The CCH group experienced more transient complications (stiffness and hematoma) during the first week and were more satisfied (VAS satisfaction) from 1 year to the 5-year follow-up.

Conclusions: The main finding of this study is that CCH and PNF were equally effective in reducing MCP flexion contracture, but the correction of contracture lasted longer in the CCH group.

Level of evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.