Comparison of the Unilateral and the Bilateral Pedicle Screw Fixation without Using an Interbody Cage: Randomized Clinical Trial

Abstract

BACKGROUND: Lumbar spine instability is one of the main causes of low back pain and has become more prevalent in recent years. Bilateral pedicle screw fixation is used to perform posterior lumbar stabilization, which is complemented by the installation of an interbody cage. AIM: The aim of the study was evaluating of the results of unilateral and bilateral pedicle screw fixation without using of an interbody cage. METHODS: A prospective randomized study of 96 patients was carried out. Forty-seven patients were assigned to the group of the unilateral pedicle screw fixation versus 49 patients were moved to the group of the bilateral pedicle screw fixation of the lumbar spine. Of the 96 patients, 80 patients eventually were included in the study. However, seven patients in the first group and nine patients were lost to follow-up. Surgery timing, blood loss volume, clinical outcomes (scores on the Oswestry disability index [ODI], EQ-5D and visual analogue scale [VAS]) were evaluated in 6–12 months after surgical treatment. All the patients included in this study underwent functional and control computed tomography in 12 months after surgery. RESULTS: Both groups showed a significant improvement in VAS, EQ-5D, and ODI in 1 year after surgical treatment. The two groups significantly differed in the surgery timing (unilateral – 90.2 min; and bilateral – 129.4 min) and blood loss volume (unilateral – 152.7 ml; and bilateral – 230.1 ml), p < 0.05. CONCLUSIONS: Unilateral and bilateral pedicle screw fixation showed similar clinical results, while results in both types of fixation differed in slight manner. However, the duration of surgical treatment and intraoperative blood loss volume proved to be lower for the unilateral fixation group, which indicates that the use of the unilateral fixation can be the choice of performing posterior stabilization at a single-level instability of the spine without using an interbody cage.