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

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. TRIAL REGISTRATION:Chinese Clinical Trial Registry ChiCTR2100046727.