1. 2022;25;E133-E140Efficacy and Safety of Establishing an Optimal Path Through Unilateral Pedicle Under the Assistance of Surgical Robot in Percutaneous Kyphoplasty
   Prospective Study
   Jun Qian, PhD, Chao Fang, MD, Peng Ge, MD, Ren-Jie Zhang, PhD, Pei-wen Song, PhD, Peng Xu, PhD, Yong Zhang, PhD, and Cai-Liang Shen, PhD.

BACKGROUND: Despite percutaneous kyphoplasty (PKP) being widely used to treat osteoporotic vertebral compression fractures (OVCFs), the details of puncture are still controversial. With the development of surgical robots in spine surgery, robotic-assisted PKP surgery will become a promising treatment strategy.

OBJECTIVES: To evaluate the efficacy and safety of establishing an optimal working path through a unilateral pedicle approach to improve bone cement distribution under the assistance of a surgical robot in percutaneous kyphoplasty.

STUDY DESIGN: Experimental and prospective study.

METHODS: PKP surgery under the assistance of the TINAVI robot was performed on 78 patients with osteoporotic vertebral compression fractures (OVCFs) from May 2018 to January 2020 in a single spine center. During the operation, the optimal path of the working channel made through unilateral pedicle puncture was designed according to the details of the fractured vertebral body under the guidance of the TINAVI surgical robot. Visual analog scale (VAS) scores of back pain, intraoperative blood loss, surgical time, and complications were recorded and evaluated. Postoperative fluoroscopy and 3D-CT were used to evaluate the distribution of bone cement.

RESULTS: We have successfully performed 78 PKP surgeries under the assistance of the TINAVI robot. The mean procedure time was 13.9 ± 2.6 minutes from the beginning of C-arm scan to finish the injection of bone cement, and the intraoperative blood loss was 5.4 ± 2.8 mL. Pain of all cases was relieved immediately and significantly after PKP surgery; the VAS score was 7.5 ± 2.3 before surgery and 1.4 ± 0.8 post-surgery. The mean volume of bone cement was 4.7 ± 1.9 mL, and bone cement leakage occurred at the anterior edge of the fractured vertebral body in 2 patients, with no neurological and vascular injury in any of the cases. Postoperative fluoroscopy and 3D-CT showed that a good bone cement distribution evenly through unilateral pedicle puncture in the fractured vertebral body in all cases except the bone cement leakage in 2 patients.

LIMITATIONS: More cases are needed to evaluate the efficacy and stability of robot-assisted PKP surgery. A control group of PKP performed freehand should be included in this study.

CONCLUSIONS: Robotic-assisted PKP surgery through the unilateral approach to establishing an optimal working channel is a safe and available procedure for treating OVCFs in terms of better distribution of bone cement, high accuracy, good repeatability, and less surgical trauma.

KEY WORDS: Surgical robot, percutaneous kyphoplasty, unilateral pedicle approach, osteoporotic vertebral compression fractures, TINAVI, optimal path, spinal surgery, treatment strategy