Unilateral Percutaneous Kyphoplasty Using a Novel Guide Device for Thoracolumbar Osteoporotic Vertebral Fracture

Abstract

Objectives: Unilateral percutaneous kyphoplasty (UPKP) has been effective in reducing the operative time, cement volume, and cement leakage (CL) rate compared with bilateral kyphoplasty. However, no device can help to determine the trajectory during operation, especially the inner inclination angle. To assess the safety and efficacy of a novel guide device (GD) for UPKP in the treatment of thoracolumbar osteoporotic vertebral fractures (TLOVFs).

Methods: From January 2019 to May 2021, 31 patients diagnosed with single TLOVF who underwent UPKP were retrospectively reviewed. The patients were divided into two groups: traditional UPKP (UPKP group, 15 patients) and UPKP assisted with GD (UPKP-GD group, 16 patients). Pre-procedure demographic, clinical and radiologic characteristics, operative procedure details, and clinical and radiologic outcomes at 1 day and 12 months post-procedure were collected. Statistical analyses were carried out using SPSS 24.0. The baseline characteristics of the two groups were compared by the independent sample t test or the χ² test. The anterior height or local kyphotic angle (LKA) of the fractured vertebrae, visual analog scale (VAS) score, and Oswestry Disability Index (ODI) within groups were compared using the paired t test.

Results: A total of 31 patients (five men and 26 women; age range: 58-90 years) completed the full 12-month postoperative follow-up schedule. No significant differences were observed between treatment groups with respect to sex, age, body mass index, preoperative bone mineral density, or surgical level. Compared with the UPKP group, the operation time in the UPKP-GD group was significantly shorter (40.8 ± 5.5 min vs. 48.5 ± 8.5 min, p = 0.005), and the number of intraoperative fluoroscopy times in the UPKP-GD group was significantly decreased (20.6 ± 4.5 vs. 25.2 ± 2.4, p = 0.001). Five (31.3%) patients in the UPKP-GD group and four (26.7%) patients in the UPKP group had bone CL. The VAS and ODI scores, anterior height and LKA of the fractured vertebrae were significantly improved after surgery in each group. No significant differences in postoperative VAS and ODI scores, anterior height or LKA of the fractured vertebrae, volume of injected cement or CL were observed between the two groups.

Conclusion: Unilateral puncture using a novel GD is a safe and effective technique for patients with TLFs and UPKP assisted with a novel GD is associated with fewer intraoperative fluoroscopy times and shorter operation time.

Keywords: Guide Device; Percutaneous Kyphoplasty; Thoracolumbar Osteoporotic Vertebral Fracture; Unilateral.