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 χ 2 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 AE 5.5 min vs. 48.5 AE 8.5 min, p = 0.005), and the number of intraoperative fluoroscopy times in the UPKP-GD group was significantly decreased (20.6 AE 4.5 vs. 25.2 AE 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.

O-Arm- and Guide-Device-Assisted Personalized Percutaneous Kyphoplasty for Thoracolumbar Osteoporotic Vertebral Compression Fractures

“…We have given much attention to the preoperative planning [14,15] and 3D printing technologies [16][17][18][19][20] used in percutaneous vertebroplasty (PVP)/PKP, and previous studies have shown that PVP with preoperative puncture design is not only reasonably safe and effective for OVCFs but also involves less radiation, shorter operation times and fewer complications than traditional PVP [14,15]. Our research has indicated that unilateral puncture using a novel 3D-printed guide device is a safe and effective technique for OVCFs and is associated with fewer intraoperative fluoroscopy exposures and shorter operation times [21]. During PKP, the conventional methods used for Jamshidi needle placement and guidewire advancement into the pedicle require numerous radiographic images.…”

“…In previous studies, preoperatively designed PVP involved less radiation, a shorter operation and fewer complications than traditional PVP [14,15]. Our previous research has also indicated that unilateral PKP using a novel 3D-printed guide device is a safe and effective technique for OVCFs [21]. The 3D-printed guide devices, including an intradermal locator and an angle-measuring device, were used to accurately determine the entry point and angle of trajectory.…”

“…With the help of our novel intradermal locator, the best bone puncture point could be accurately located. After determining the bone puncture point, the angle of the puncture trajectory could be adjusted using the angle-measuring device, and repeat fluoroscopy to determine the relationship between the needle and the pedicle was avoided [21]. However, there may be errors when the patient undergoes supine CT imaging in the CT examination room and enters the operating room in the prone posture for surgery.…”

“…Second, the sample size was relatively small, the follow-up time was relatively short, and long-term patient complications were not evaluated, which may affect the accuracy of the conclusions. Third, it is important to compare the radiation dose between the two groups, and we evaluated the number of fluoroscopy exposures to indirectly compare the radiation dose, which may not yield an accurate estimate; however, this measure has been used in prior studies and thus has some comparative value [21,31,32]. Future prospective randomized controlled studies involving a larger sample of patients with longer follow-up times and more radiation dose data could address these limitations.…”

“…The novel guide device (Figure 1) includes a puncture needle or Kirschner wire (red line in Figure 1A), an intradermal locator (black tube in Figure 1A) and an angle-measuring device (pink semicircle in Figure 1A) [21]. The novel guide device was created by reverse engineering and rapid prototyping techniques (Figure 1B).…”