A randomized trial comparing the clinical efficacy and safety of a novel steerable percutaneous kyphoplasty with traditional PKP in osteoporotic vertebral fractures

Abstract

Background: Percutaneous kyphoplasty (PKP) is a highly practical technology to treat osteoporotic vertebral compression fractures (OVCFs). However, the operation time and radiation exposure remain problematic. This study explored the differences in surgical effects and safety between a novel steerable percutaneous kyphoplasty (S-PKP) and traditional PKP in order to achieve better clinical outcomes for OVCF patients. It is also exploring whether the new technology could reduce the radiation exposure.Methods: This study recruited 72 patients (between March 2019 and January 2020) with OVCFs (single vertebra). The patients were semi-randomly divided these patients into two groups according to ID numbers: a S-PKP group (33 cases) and a PKP group (39 cases). We evaluated the clinical efficacy using the kyphotic Cobb angle, Oswestry disability index (ODI), visual analogue scale (VAS) score, injected cement volume, operation time, intraoperative radiation times, bone cement leakage, and postoperative complications.Patients were followed up once preoperatively, and at 1 day, 6 months, and 1 year postoperatively.Results: There were no cases of cement leakage or postoperative complications. There were no significant differences in gender, age, Bone mineral density T-score (BMD T) value, Cobb angle between the two groups (P>0.05). Intraoperative bone cement injection was approximately 5.25±1.37 and 5.32±1.29 mL in the PKP and S-PKP groups respectively. The postoperative VAS score and ODI of the two groups at 1 day, 6 months, and 1 year were markedly lower than before (P<0.05). There was a considerable improvement in the Cobb angle postoperatively (P<0.05). However, as the follow-up time extended, the Cobb Angle increased. The operation time and X-ray exposure times of patients in the PKP group were notably higher than those in the S-PKP group. The operation time was 51.59±9.14 min in the PKP group and 30.76±4.82 min in the S-PKP group. The frequency of intraoperative radiation was 105.9±31.93 times in the PKP group and 47.42±11.88 times in the S-PKP group. Conclusions:Early results showed that S-PKP is a safe and efficient method for the treatment of OVCFs. S-PKP can reduce the operation time and radiation exposure.

Continuous cement leakage along the posterior longitudinal ligament of the intraspinal epidural during a percutaneous vesselplasty: A case report and literature review

“…It is widely used for its advantages, such as less trauma and good postoperative effect ( 8 ). Notably, percutaneous vesselplasty is a further surgical approach based on PKP ( 9 , 10 ). The progress of technical without affecting the diffusion of bone cement greatly reduce the possibility of cement leakage into the spinal canal through the fracture line or the posterior edge of discontinuous vertebral body and reduce the most serious neurological complications ( 11 ).…”

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

“…The inclusion criteria were as follows: (1) a single-level fracture in the thoracolumbar vertebrae (T11-L2) identified through preoperative radiological findings and tapping pain at the spinal process of the fractured vertebral body; (2) a preoperative visual analogue scale (VAS) pain score over 5; (3) a new fracture without any previous fractures of the vertebrae, as determined through preoperative radiological findings; (4) a T value ≤ −2.5, as determined by a bone mineral density (BMD) examination of the lumbar vertebrae; and (5) an intact posterior vertebral wall. The exclusion criteria were as follows: (1) a history of previous vertebral augmentation; (2) a pathological fracture caused by a tumour or spine infection; and (3) comorbidities involving thyroid dysfunction. Patients were treated by the same senior surgeon (H.W.…”

“…Percutaneous kyphoplasty (PKP) is a minimally invasive surgery that has been found to be a safe and effective therapy for OVCFs. Currently, the standard technique for PKP is a bilateral approach [2,3].…”

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

“…[5][6][7][8] Percutaneous kyphoplasty (PKP) is a rapid, effective, and minimally invasive technique for treating TLOVFs in elderly patients, and it can speed recovery of function and improve quality of life with fewer complications compared with conservative treatment. [9][10][11][12][13] However, surgeons are heavily dependent on image-guided navigation, especially when the surgeon is inexperienced. The radiation dose of the operator was highest in C-arm-guided minimally invasive spine surgery.…”