Shengxiang Ao1, Junlong Wu1, Wenjie Zheng2, Yue Zhou3. 1. Department of Orthopaedics, The Second Affiliated Xinqiao Hospital of Army Medical University, Chongqing, China. 2. Department of Orthopaedics, The Second Affiliated Xinqiao Hospital of Army Medical University, Chongqing, China. Electronic address: 120198336@qq.com. 3. Department of Orthopaedics, The Second Affiliated Xinqiao Hospital of Army Medical University, Chongqing, China. Electronic address: happyzhou@vip.163.com.
Abstract
OBJECTIVE:Percutaneous endoscopic lumbar discectomy (PELD) has become a mature and mainstream surgical technique for treating lumbar disc herniation (LDH); however, there is a steep learning curve with PELD, especially for puncture and foraminoplasty. In this study, we assessed the outcome and safety of a novel quantificational and targeted foraminoplasty device named ZESSYS for LDH. METHODS:From September to December of 2016, 70 patients with symptomatic LDH were enrolled in the study. The patients were assigned randomly to either the ZESSYS group or the conventional TESSYS group. We recorded the cannula introduction time, decompression time, radiation exposure time, intraoperative pain feeling score, visual analog scale, Oswestry Disability Index, and Macnab criteria score of the 2 groups. The mean follow-up period was 14 months. RESULTS: The average cannula introduction time (16.50 ± 3.29 minutes) and the radiation exposure time (40.71 ± 6.23 seconds) in the ZESSYS group were significantly reduced compared with the TESSYS group (cannula introduction time, 20.06 ± 3.37 minutes, P = 0.000; radiation exposure time, 49.20 ± 7.84 seconds, P = 0.000). Intraoperative pain feeling score in the ZESSYS group was significantly improved compared with the TESSYS group (P = 0.021). There were no significant differences between the 2 groups for decompression time (P = 0.617), Macnab criteria (P = 0.769), or visual analog scale and Oswestry Disability Index scores at the same time point (P > 0.05). No serious complication was observed in any patients in either group. CONCLUSIONS: The novel targeted foraminoplasty technique with the specially designed double-cannulas is an effective and safe treatment for lumbar intervertebral disc herniation. It reduces the difficulty of PELD learning, minimizes radiation exposure, and decreases intraoperative pain associated with foraminoplasty.
RCT Entities:
OBJECTIVE: Percutaneous endoscopic lumbar discectomy (PELD) has become a mature and mainstream surgical technique for treating lumbar disc herniation (LDH); however, there is a steep learning curve with PELD, especially for puncture and foraminoplasty. In this study, we assessed the outcome and safety of a novel quantificational and targeted foraminoplasty device named ZESSYS for LDH. METHODS: From September to December of 2016, 70 patients with symptomatic LDH were enrolled in the study. The patients were assigned randomly to either the ZESSYS group or the conventional TESSYS group. We recorded the cannula introduction time, decompression time, radiation exposure time, intraoperative pain feeling score, visual analog scale, Oswestry Disability Index, and Macnab criteria score of the 2 groups. The mean follow-up period was 14 months. RESULTS: The average cannula introduction time (16.50 ± 3.29 minutes) and the radiation exposure time (40.71 ± 6.23 seconds) in the ZESSYS group were significantly reduced compared with the TESSYS group (cannula introduction time, 20.06 ± 3.37 minutes, P = 0.000; radiation exposure time, 49.20 ± 7.84 seconds, P = 0.000). Intraoperative pain feeling score in the ZESSYS group was significantly improved compared with the TESSYS group (P = 0.021). There were no significant differences between the 2 groups for decompression time (P = 0.617), Macnab criteria (P = 0.769), or visual analog scale and Oswestry Disability Index scores at the same time point (P > 0.05). No serious complication was observed in any patients in either group. CONCLUSIONS: The novel targeted foraminoplasty technique with the specially designed double-cannulas is an effective and safe treatment for lumbar intervertebral disc herniation. It reduces the difficulty of PELD learning, minimizes radiation exposure, and decreases intraoperative pain associated with foraminoplasty.