Study design: Clinical and radiographic results of a randomized, controlled, double-blind clinical trial OBJECTIVE:: To investigate the clinical applicability of a ball-point slide-type interbody distractor in posterior reduction and internal fixation for mid- to high-grade isthmic spondylolisthesis.
Summary of background data: Posterior reduction and internal fixation is the effective treatment for spondylolisthesis. However, for the mid and high-grade isthmic spondylolisthesis patients with the conditions of vertebral osteoporosis and extremely narrow intervertebral space, the reduction is difficult; post-surgery intervertebral space height lost becomes serious; the fracture and loosening rate of fixation system is higher. No study regarding the prevention of these adverse outcomes in this technique is reported.
Methods: A total of 59 patients of mid and high-grade isthmic spondylolisthesis were randomly divided into random groups (investigational group and control group) applying simple randomized method in this study. In addition, 30 patients received posterior reduction and internal fixation as control. Twenty-nine patients received posterior reduction and internal fixation by ball-point slide-type interbody distractor were assigned to the investigational group. X-ray examination was performed before and after operation. The degree of reduction, height of intervertebral space were compared. The preoperative and postoperative Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) were evaluated. Additionally, rate of the fixation system fracture was also assessed.
Results: Before treatment, there were no significant differences in ISH (P = .72), DR (P = .85), VAS of back pain (P = .55), VAS of leg pain (P = .83) and ODI (P = .68) were found between 2 groups. After 12-month treatment, there were no significant differences in ISH (P = .26), VAS of back pain (P = .09) and VAS of leg pain (P = .96) between two groups. Significant differences of DR (P = .02), ODI (P = .03) and adverse events (P = .00) were found between 2 groups.
Conclusions: The results of this prospectively study showed that the ball-point slide-type interbody distractor in the posterior reduction and internal fixation produced good outcomes after 12-month treatment. More high quality randomized controlled trials and cases should still be needed to warrant the results of this study.