Zhang Zhiwu, Shao Jiashen, Su Nan, Li Xiang, Fei Qi, Yang Yong, Meng Hai
Department of Orthopedics, Beijing Friendship hospital, Capital Medical University, No 95, Yong'an Road, Xicheng District 100050, Beijing, People's Republic of China.
BMC Musculoskelet Disord. 2025 May 10;26(1):463. doi: 10.1186/s12891-025-08715-8.
To investigate the efficacy and safety of hybrid surgery based on the Waveflex internal fixation system for the treatment of lumbar degenerative disease.
A retrospective analysis was conducted on 31 consecutive patients who underwent hybrid surgery (fusion combined with non-fusion surgery) using the Waveflex internal fixation system for lumbar degenerative diseases between December 2019 and May 2021. The final follow-up assessments were completed by October 2024, yielding a follow-up period ranging from 41 to 58 months (mean ± SD: 48.1 ± 4.2 months). Postoperative outcomes were assessed using a comprehensive set of multidimensional indicators, encompassing both clinical and radiological evaluations. Clinical efficacy was evaluated based on pain intensity (measured by the Visual Analogue Scale, VAS), functional disability (assessed via the Oswestry Disability Index, ODI), incidence of postoperative complications, and patient satisfaction level. Radiological analysis included assessments of bone fusion rate, disc height measurements (anterior, middle, and posterior) at the non-fusion segment, range of motion (ROM) at the non-fusion segment, and dynamic changes in ROM at adjacent segments.
All patients successfully completed the surgery and finished the follow-up. Three months, six months and the final follow-up VAS scores and ODI were significantly improved compared with the preoperative period, and the differences were statistically significant (P < 0.05). One case of postoperative complication occurred, involving delayed wound healing due to fat liquefaction at the incision site. The condition resolved completely after four weeks of conservative management, including regular dressing changes. At the final follow-up, the efficacy was excellent in 28 cases, good in 3 cases, moderate in 0 cases, and poor in 0 cases, with a satisfaction level rate of 100%. At the final follow-up, all index segments achieved bony fusion, with a fusion rate of 100%. There was no statistically significant difference between the disc height of the dynamically fixed segments compared with that of the preoperative period (P > 0.05). The ROM of the dynamically fixed segment decreased compared with the preoperative period but there was no statistical difference (P > 0.05). The ROM in adjacent segment of the dynamically fixed segment increased compared with the preoperative period, which was also not statistically different (P > 0.05).
Hybrid surgery based on the Waveflex internal fixation system for the treatment of lumbar degenerative diseases can achieve a favorable early clinical outcome. It is able to retain a certain degree in mobility of the dynamic fixed segment and effectively maintains the dynamic fixed segment intervertebral space height without affecting the adjacent segment.
Not applicable.
探讨基于Waveflex内固定系统的混合手术治疗腰椎退行性疾病的疗效及安全性。
对2019年12月至2021年5月期间连续31例行基于Waveflex内固定系统的混合手术（融合联合非融合手术）治疗腰椎退行性疾病的患者进行回顾性分析。最终随访评估于2024年10月完成，随访时间为41至58个月（平均±标准差：48.1±4.2个月）。采用一套综合的多维指标评估术后结果，包括临床和影像学评估。临床疗效根据疼痛强度（采用视觉模拟评分法，VAS）、功能障碍（通过Oswestry功能障碍指数，ODI）、术后并发症发生率及患者满意度进行评估。影像学分析包括骨融合率评估、非融合节段椎间盘高度测量（前、中、后）、非融合节段活动度（ROM）以及相邻节段ROM的动态变化。
所有患者均成功完成手术并完成随访。与术前相比，术后3个月、6个月及最终随访时的VAS评分和ODI均显著改善，差异具有统计学意义（P<0.05）。发生1例术后并发症，为切口处脂肪液化导致伤口愈合延迟。经4周保守治疗，包括定期换药，病情完全缓解。最终随访时，疗效优28例，良3例，可0例，差0例，满意度为100%。最终随访时，所有指标节段均实现骨融合，融合率为100%。动态固定节段的椎间盘高度与术前相比无统计学差异（P>0.05）。动态固定节段的ROM较术前降低，但无统计学差异（P>0.05）。动态固定节段相邻节段的ROM较术前增加，也无统计学差异（P>0.05）。
基于Waveflex内固定系统的混合手术治疗腰椎退行性疾病可获得良好的早期临床疗效。它能够保留动态固定节段一定程度的活动度，并有效维持动态固定节段的椎间隙高度，且不影响相邻节段。
不适用。
