Randomized Controlled Trial Comparing the Clinical Effectiveness of Collagenase Injection (Xiaflex®) and Palmar Fasciectomy in the Management of Dupuytren's Contracture.

Abstract

Introduction: Limited palmar fasciectomy (LPF) and collagenase injection (CI) are the most common procedures to manage symptoms of Dupuytren's Disease. This randomized controlled trial (RCT) aimed to directly compare patient outcomes 12 months following CI and LPF. Methods: Twenty-two patients with Dupuytren's Disease were randomized to either LPF or CI. The primary outcome was health state measured by the Michigan Hand Questionnaire. Secondary outcomes were health status (The Health Utility Index-3), function (The Unité Rhumatologique des Affections de la Main and The Southampton Dupuytren's Scoring Scheme), and range of motion (ROM) of treated digits. Measurements were collected at baseline and 1-, 3-, 6-, and 12-months post-procedure. Results: Thirteen patients were randomized to the LPF and eight patients to the CI group. Most patients (85.7%) were male; the average age of the sample was 65.3 years. No statistically significant difference in the MHQ (mean difference [MD]: -12.4 (95% confidence interval [CI]: -30.0, 5.2)), SDSS (.9 (-4.0, 5.8)), URAM (-.9 (-14.4, 12.6)) or HUI-3 (-.04, -.2, .2)) was found between groups 12-months post-operatively. There was no statistically significant difference in 12-month loss of extension between groups at the MCP (-16.9 (-35.4, 1.7) or PIP (-2.9 (-22.9, 17.1) joints. Three CI patients and 1 LPF patient developed a contracture in the same digit requiring surgery. Conclusion: Results should be interpreted with caution given the small sample size. Available data suggests both techniques are reasonable for managing Dupuytren's Disease. Considerations for future RCTs are provided.