The First Affiliated Hospital, Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.
Sci Rep. 2024 May 7;14(1):10437. doi: 10.1038/s41598-024-60940-8.
The Waveflex semi-rigid-dynamic-internal-fixation system shows good short-term effects in the treatment of lumbar degenerative diseases, but there are few long-term follow-up studies, especially for recovery of sagittal balance. Fifty patients with lumbar degenerative diseases treated from January 2016 to October 2017 were retrospectively analysed: 25 patients treated with Waveflex semi-rigid-dynamic-internal-fixation system (Waveflex group) and 25 patients treated with double-segment PLIF (PLIF group). Clinical efficacy was evaluated by Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI). Imaging data before surgery and at 3 months, 1 year, and 5 years postoperatively was used for imaging indicator assessment. Local disc degeneration of the cephalic adjacent segment (including disc height index (DHI), intervertebral foramen height (IFH), and range of motion (ROM)) and overall spinal motor function (including lumbar lordosis (LL), pelvic incidence (PI), sacral slope (SS), pelvic tilt (PT), and |PI-LL|) were analysed. Regarding clinical efficacy, comparison of VAS and ODI scores between the Waveflex and PLIF groups showed no significant preoperative or postoperative differences. The comparison of the objective imaging indicators showed no significant differences in the DHI, IFH, LL, |PI-LL|, and SS values between the Waveflex and PLIF groups preoperatively and 3 months postoperatively (P > 0.05). These values were significantly different at 1 and 5 years postoperatively (P < 0.05), and the Waveflex group showed better ROM values than those of the PLIF group (P < 0.05). PI values were not significantly different between the groups, but PT showed a significant improvement in the Waveflex group 5 years postoperatively (P < 0.05). The Waveflex semi-rigid dynamic fixation system can effectively reduce the probability of intervertebral disc degeneration in upper adjacent segments. Simultaneously, patients in the Waveflex group showed postoperative improvements in LL, spinal sagittal imbalance, and quality of life.
Waveflex 半刚性动力内固定系统在治疗腰椎退行性疾病方面具有良好的短期疗效，但长期随访研究较少，特别是在矢状位平衡的恢复方面。回顾性分析 2016 年 1 月至 2017 年 10 月收治的 50 例腰椎退行性疾病患者：25 例采用 Waveflex 半刚性动力内固定系统治疗（Waveflex 组），25 例采用双节段 PLIF 治疗（PLIF 组）。采用视觉模拟评分（VAS）和 Oswestry 功能障碍指数（ODI）评估临床疗效。术前及术后 3 个月、1 年和 5 年的影像学资料用于影像学指标评估。分析头侧相邻节段（包括椎间盘高度指数（DHI）、椎间孔高度（IFH）和活动度（ROM））和整体脊柱运动功能（包括腰椎前凸角（LL）、骨盆入射角（PI）、骶骨倾斜角（SS）、骨盆倾斜角（PT）和 |PI-LL|）的局部椎间盘退变情况。关于临床疗效，Waveflex 组和 PLIF 组 VAS 和 ODI 评分比较，术前及术后均无统计学差异。客观影像学指标比较，术前及术后 3 个月，Waveflex 组与 PLIF 组 DHI、IFH、LL、|PI-LL|、SS 比较差异无统计学意义（P>0.05）。术后 1 年、5 年比较差异有统计学意义（P<0.05），Waveflex 组 ROM 值优于 PLIF 组（P<0.05）。两组 PI 值比较差异无统计学意义，但 Waveflex 组术后 5 年 PT 值明显改善（P<0.05）。Waveflex 半刚性动力固定系统能有效降低上相邻节段椎间盘退变的概率。同时，Waveflex 组患者术后腰椎前凸角、脊柱矢状位平衡及生活质量均有改善。
