The clinical efficacy of hybrid surgery based on the Waveflex semi-rigid dynamic internal fixation system for the treatment of lumbar degenerative diseases: over three-year follow-up study.

objectiveTo investigate the efficacy and safety of hybrid surgery based on the Waveflex internal fixation system for the treatment of lumbar degenerative disease.

methodsA 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.

resultsAll 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).

conclusionHybrid 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. CLINICAL TRIAL NUMBER: Not applicable.