Multicenter randomized trial of carpal tunnel release with ultrasound guidance versus mini-open technique.

IF 2.9 3区医学 Q3 ENGINEERING, BIOMEDICAL

Expert Review of Medical Devices Pub Date : 2023-07-01 DOI:10.1080/17434440.2023.2218548

Kyle R Eberlin, Benjamin P Amis, Thomas P Berkbigler, Christopher J Dy, Mark D Fischer, James L Gluck, F Thomas D Kaplan, Thomas J McDonald, Larry E Miller, Alexander Palmer, Paul E Perry, Marc E Walker, James F Watt

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引用次数: 2

Abstract

Background: Comparative studies of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open CTR (mOCTR) are limited, prompting development of this randomized trial to compare efficacy and safety of these techniques.

Research design and methods: Patients were randomized (2:1) to CTR-US or mOCTR, treated by experienced hand surgeons (median previous cases: 12 CTR-US; 1000 mOCTR), and followed for 3 months.

Results: Among 149 randomized patients, 122 received CTR-US (n = 94) or mOCTR (n = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) (p < 0.001). Median time to return to daily activities (2 vs. 2 days; p = 0.81) and work (3 vs. 4 days; p = 0.61) were similar. Both groups reported statistically significant and clinically important improvements in Boston Carpal Tunnel Questionnaire Symptom Severity and Functional Status Scales, Numeric Pain Scale, and EuroQoL-5 Dimension 5-Level, with no statistical differences between groups. Freedom from wound sensitivity and pain favored CTR-US (61.1% vs. 17.9%; p < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%; p = 0.55).

Conclusions: The efficacy and safety of CTR-US were comparable to mOCTR despite less previous surgical experience with CTR-US. The choice of CTR technique should be determined by shared decision-making between patient and physician.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT05405218.

查看原文本刊更多论文

超声引导下腕管释放与小开口技术的多中心随机试验。

背景:超声引导下腕管释放(cr - us)与迷你开放式CTR (mOCTR)的比较研究有限，促使本随机试验的开展来比较这些技术的有效性和安全性。研究设计和方法:患者随机(2:1)分为CTR-US组或mOCTR组，由经验丰富的手外科医生治疗(既往病例中位数:12 CTR-US;1000 mOCTR)，随访3个月。结果:149例随机患者中，122例接受了tr - us (n = 94)或mOCTR (n = 28)。腕部(cr - us)平均切口长度为6±2mm，手掌(mOCTR)为22±7mm (p p = 0.81)，工作(3天vs. 4天;P = 0.61)相似。两组在波士顿腕管问卷症状严重程度和功能状态量表、数字疼痛量表和EuroQoL-5维度5-Level上均报告有统计学意义和临床意义的改善，组间无统计学差异。无伤口敏感和疼痛倾向于cr - us (61.1% vs. 17.9%;p = 0.55)。结论:尽管以往的手术经验较少，但cr - us的疗效和安全性与mOCTR相当。CTR技术的选择应由患者和医生共同决定。临床试验注册:www.clinicaltrials.gov标识符:NCT05405218。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Review of Medical Devices 医学-工程：生物医学

CiteScore

5.90

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： The journal serves the device research community by providing a comprehensive body of high-quality information from leading experts, all subject to rigorous peer review. The Expert Review format is specially structured to optimize the value of the information to reader. Comprehensive coverage by each author in a key area of research or clinical practice is augmented by the following sections: Expert commentary - a personal view on the most effective or promising strategies Five-year view - a clear perspective of future prospects within a realistic timescale Key issues - an executive summary cutting to the author''s most critical points In addition to the Review program, each issue also features Medical Device Profiles - objective assessments of specific devices in development or clinical use to help inform clinical practice. There are also Perspectives - overviews highlighting areas of current debate and controversy, together with reports from the conference scene and invited Editorials.