Massachusetts General Hospital, Boston, MA, USA.
ATX Orthopedics, Austin, TX, USA.
Expert Rev Med Devices. 2023 Jul;20(7):597-605. doi: 10.1080/17434440.2023.2218548. Epub 2023 May 30.
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.
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.
Among 149 randomized patients, 122 received CTR-US ( = 94) or mOCTR ( = 28). Mean incision length was 6 ± 2 mm in the wrist (CTR-US) vs. 22 ± 7 mm in the palm (mOCTR) ( < 0.001). Median time to return to daily activities (2 vs. 2 days; = 0.81) and work (3 vs. 4 days; = 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%; < 0.001). Adverse event rates were low in each group (2.1% vs. 3.6%; = 0.55).
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.
www.clinicaltrials.gov identifier is NCT05405218.
超声引导下腕管松解术（CTR-US）与小切口开放腕管松解术（mOCTR）的比较研究有限，这促使我们开展了这项随机试验，以比较这两种技术的疗效和安全性。
患者被随机（2:1）分为 CTR-US 组或 mOCTR 组，由经验丰富的手外科医生进行治疗（中位数既往病例数：12 例 CTR-US；1000 例 mOCTR），并随访 3 个月。
在 149 例随机患者中，122 例接受了 CTR-US（ = 94）或 mOCTR（ = 28）治疗。手腕处的平均切口长度为 6 ± 2 mm（CTR-US），手掌处为 22 ± 7 mm（mOCTR）（ < 0.001）。恢复日常活动（2 天 vs. 2 天； = 0.81）和工作（3 天 vs. 4 天； = 0.61）的中位时间相似。两组患者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 级评分方面均报告了统计学上显著和临床上重要的改善，且组间无统计学差异。在无伤口敏感性和疼痛方面，CTR-US 更具优势（61.1% vs. 17.9%； < 0.001）。两组不良事件发生率均较低（2.1% vs. 3.6%； = 0.55）。
尽管 CTR-US 的手术经验较少，但 CTR-US 的疗效和安全性与 mOCTR 相当。选择 CTR 技术应取决于患者和医生之间的共同决策。
www.clinicaltrials.gov 标识符为 NCT05405218。
