Efficacy and safety of ultrasonic bone scalpel in posterior cervical expansive open-door laminoplasty for cervical degenerative diseases: A prospective randomized controlled trial.

Abstract

BackgroundKey instruments used in posterior cervical expansive open-door laminoplasty (CEOL), such as the high-speed drill (HSD) and the ultrasonic bone scalpel (UBS), are selected based on surgeon preference. However, skepticism remains among some surgeons regarding the superiority of the HSD over the widely used UBS, necessitating a scientific evaluation of its practical utility.ObjectiveTo evaluate the efficacy and safety of the ultrasonic bone scalpel compared to the high-speed drill in cervical expansive open-door laminoplasty using a posterior cervical approach in a prospective randomized controlled trial.MethodsThis prospective study, conducted after obtaining prior informed consent, involved 40 patients diagnosed with cervical degenerative diseases who underwent cervical expansive open-door laminoplasty between July 2018 and June 2021. The patients were randomly divided into two groups: the ultrasonic bone scalpel group (n = 20) and the high-speed drill group (n = 20). Surgeons could not be blinded due to the nature of the intervention, but outcome assessors were blinded to group allocation where feasible. Surgical time, open-door time, intraoperative blood loss, postoperative drainage loss, post-operative complications, and functional outcomes were compared between the two groups.ResultsNo statistically significant difference was observed between the two groups in terms of intraoperative blood loss, post-operative complications, screw migration, plate fracture, or spinal cord expansion. However, the ultrasonic bone scalpel group demonstrated significantly shorter surgical time, open-door time, and reduced postoperative drainage loss compared to the high-speed drill group (p < .05). The reduced drainage volume may be attributed to thermal sealing of small vessels by the UBS rather than solely reduced tissue trauma. No significant differences were observed in the Visual Analog Scale (VAS) scores, bony union at the hinge, or Japanese Orthopedic Association (JOA) score improvement rates between the two groups at 1 week, 3 months, and 1 year postoperatively. While the UBS group showed numerical reductions in complication rates (e.g., dural tear: 0% vs 5%, p = .311), these differences did not reach statistical significance, likely due to the limited sample size.ConclusionsThe study concluded that USB significantly reduces operation time, open-door time, and postoperative drainage loss. However, the study's limited sample size may have been insufficient to detect differences in complication rates between groups.