Jiasen Lin, Yuxiang Li, Liang Jiang, Yi Long, Honglve Li, Yongbo Wang, Weikuan Geng, Xinghao Deng, Congda Zhang, Rui Yang, Jingyi Hou
Department of Sports Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510120, P. R. China.
Bioscience and Biomedical Engineering Thrust, The Hong Kong University of Science and Technology (Guangzhou), Nansha, Guangzhou, 511458, China.
BMC Musculoskelet Disord. 2025 Jul 28;26(1):721. doi: 10.1186/s12891-025-08932-1.
Carpal tunnel syndrome (CTS) is the most prevalent peripheral nerve entrapment disorder, often requiring surgical intervention. While Ultrasound-guided Looped Thread Carpal Tunnel Release (LTCTR) offers a minimally invasive alternative to carpal tunnel release, its implementation faces limitations due to insufficient specialized instruments. This cadaveric study assesses the Hybrid-J Shape Needle (HJSN), a blunt-tip, J-shaped device designed to improve safety in LTCTR procedures.
Twenty fresh-frozen cadaveric specimens (40 wrists) were included. Ten junior surgeons were randomly assigned two cadavers, performing LTCTR with normal cannula needle (NCN) on one wrist of the same cadaver, followed by HJSN on the contralateral wrist. Intraoperative structural damage such as nerve, blood vessel and tendon were assessed by blinded observer and anatomist. Post-procedural dissection confirmed transverse carpal ligament (TCL) transection completeness. Surgeons evaluated usability, adoption intent, and likelihood of recommendation using 5-point Likert scales. Biomechanical testing assessed force thresholds required for tendon and nerve penetration. Statistical analysis included Mann-Whitney U-test, Student's t-test, and Chi-square tests.
HJSN reduced operative time compared to NCN (25.10 ± 6.50 vs. 31.49 ± 6.36 min, p < 0.01) and achieved 100% complete TCL transection (20/20 vs. 16/20 for NCN, p = 0.035). NCN resulted in 3 median nerve (MN) injuries, 2 ulnar artery injuries, 2 superficial palmar arch (SPA) injuries, and 2 tendon injuries, whereas HJSN caused only 1 SPA injury (OR = 10.23, 95% CI: 1.12-93.34, p = 0.02). Biomechanical testing demonstrated HJSN required higher force to penetrate tendons (27.07 ± 2.43 N vs. 9.89 ± 2.53 N, p < 0.01) and nerves (25.75 ± 3.26 N vs. 10.72 ± 2.61 N, p < 0.01). Surgeons reported stronger preference for HJSN (3.60 ± 1.07 vs. 2.40 ± 1.07, p = 0.03) and recommendation (3.80 ± 1.23 vs. 2.20 ± 1.03, p < 0.01), though usability scores were comparable (4.10 ± 1.10 vs. 3.50 ± 1.18, p = 0.22).
HJSN's unique blunt-tip and J-shaped design improves LTCTR safety by reducing iatrogenic injuries and ensuring complete TCL release. Its biomechanical superiority and surgeon preference support clinical translation, especially for trainees. While cadaveric data are encouraging, clinical trials are needed to confirm efficacy.
腕管综合征（CTS）是最常见的周围神经卡压性疾病，常需手术干预。虽然超声引导下环形缝线腕管松解术（LTCTR）为腕管松解提供了一种微创替代方法，但其实施因缺乏专门器械而受到限制。本尸体研究评估了混合J形针（HJSN），这是一种钝头J形装置，旨在提高LTCTR手术的安全性。
纳入20个新鲜冷冻尸体标本（40只腕）。10名初级外科医生被随机分配到两个尸体，在同一尸体的一只腕上使用普通套管针（NCN）进行LTCTR，然后在对侧腕上使用HJSN。由不知情的观察者和解剖学家评估术中神经、血管和肌腱等结构损伤情况。术后解剖确认腕横韧带（TCL）切断的完整性。外科医生使用5分李克特量表评估可用性、采用意愿和推荐可能性。生物力学测试评估肌腱和神经穿透所需的力阈值。统计分析包括曼-惠特尼U检验、学生t检验和卡方检验。
与NCN相比，HJSN缩短了手术时间（25.10±6.50分钟对31.49±6.36分钟，p<0.01），并实现了100%的TCL完全切断（20/20对NCN的16/20，p=0.035）。NCN导致3例正中神经（MN）损伤、2例尺动脉损伤、2例掌浅弓（SPA）损伤和2例肌腱损伤，而HJSN仅导致1例SPA损伤（OR=10.23，95%CI：1.12-93.34，p=0.02）。生物力学测试表明，HJSN穿透肌腱（27.07±2.43N对9.89±2.53N，p<0.01）和神经（25.75±3.26N对10.72±2.61N，p<0.01）所需的力更高。外科医生报告对HJSN的偏好更强（3.60±1.07对2.40±1.07，p=0.03）和推荐可能性更高（3.80±1.23对2.20±1.03，p<0.01），尽管可用性评分相当（4.10±1.10对3.50±1.18，p=0.22）。
HJSN独特的钝头和J形设计通过减少医源性损伤并确保TCL完全松解，提高了LTCTR的安全性。其生物力学优势和外科医生的偏好支持其临床转化，尤其是对实习生而言。虽然尸体研究数据令人鼓舞，但仍需进行临床试验以确认其疗效。
