Thoma Achilles, Murphy Jessica, Gallo Lucas, Ayeni Bimpe, Thabane Lehana
Department of Surgery, Division of Plastic Surgery, McMaster University, Hamilton, ON, Canada.
Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, ON, Canada.
Plast Surg (Oakv). 2024 Nov;32(4):659-666. doi: 10.1177/22925503231161066. Epub 2023 Mar 13.
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. 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. 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. 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.
局限性掌腱膜切除术（LPF）和胶原酶注射（CI）是治疗掌腱膜挛缩症症状最常用的方法。这项随机对照试验（RCT）旨在直接比较CI和LPF术后12个月的患者预后。22例掌腱膜挛缩症患者被随机分为LPF组或CI组。主要结局指标是通过密歇根手功能问卷测量的健康状况。次要结局指标包括健康状态（健康效用指数-3）、功能（手部风湿病单位和南安普敦掌腱膜挛缩症评分方案）以及治疗手指的活动范围（ROM）。在基线以及术后1、3、6和12个月收集测量数据。13例患者被随机分配至LPF组，8例患者被分配至CI组。大多数患者（85.7%）为男性；样本的平均年龄为65.3岁。术后12个月，两组在密歇根手功能问卷（平均差值[MD]：-12.4（95%置信区间[CI]：-30.0，5.2））、南安普敦掌腱膜挛缩症评分方案（.9（-4.0，5.8））、手部风湿病单位（-.9（-14.4，12.6））或健康效用指数-3（-.04，-.2，.2））方面均未发现统计学显著差异。两组在掌指关节（-16.9（-35.4，1.7））或近端指间关节（-2.9（-22.9，17.1））的12个月伸直丧失方面无统计学显著差异。3例CI患者和1例LPF患者在同一手指出现挛缩，需要手术治疗。鉴于样本量较小，对结果的解释应谨慎。现有数据表明，这两种技术在治疗掌腱膜挛缩症方面都是合理的。文中还提供了对未来RCT的考虑因素。
