Combined use of poly(methyl methacrylate) bone cement and injectable artificial bone implantation for senile degenerative thoracic osteoporotic vertebral compression fractures: study protocol for a randomized controlled trial / 中国组织工程研究

ABSTRACT

BACKGROUND: Percutaneous kyphoplasty is an effective treatment method for senile degenerative thoracic osteoporotic vertebral compression fractures. However, its clinical long-term effect is controversial among scholars both inside and outside China. The poly(methyl methacrylate) (PMMA) bone cement commonly used in percutaneous kyphoplasty has good plasticity and formability, but its biocompatibility is not yet clear. Injectable artificial bone is a novel filling material to induce bone formation, but its long-term efficacy remains to be verified. OBJECTIVE: To compare the efficacy of OSTEOPAL?Plus PMMA bone cement and GeneX? injectable artificial bone graft in the treatment of senile degenerative thoracic osteoporotic vertebral compression fractures at 24 months postoperatively. METHODS: This is a prospective, single-center, open-label, randomized controlled clinical trial. A total of 378 patients with senile degenerative thoracic osteoporotic vertebral compression fractures will be recruited from the Department of Orthopedics, Affiliated Hospital of Qinghai University, China. The patients will be randomized into two groups and undergo percutaneous kyphoplasty. The PMMA group (n=189) will be treated with OSTEOPAL?Plus PMMA bone cement. The artificial bone group (n=189) will be treated with GeneX? injectable artificial bone. Follow-ups will be conducted at 1 week and at 3, 6, 12, and 24 months. The primary outcome measure will be the vertebral body height restoration rate at 24 months postoperatively to evaluate the repair effect of the damaged thoracic vertebra. The secondary outcome measures will be the vertebral body height restoration rate at 1 week and 3, 6, and 12 months postoperatively; the incidence of bone cement leakage at 1 week and 3, 6, 12, and 24 months postoperatively; the visual analog scale score, Oswestry Disability Index, compression rate of the anterior vertebral height, and thoracic morphology revealed by computed tomography preoperatively and at 1 week and 3, 6, 12, and 24 months postoperatively; and the incidence of adverse reactions at 1 week and 3, 6, 12, and 24 months postoperatively. DISCUSSION: Our results will verify whether OSTEOPAL?Plus PMMA bone cement and GeneX? injectable artificial bone graft are effective and safe for treating senile degenerative thoracic osteoporotic vertebral compression fractures in the short-term and at the 2-year follow-up. This study was approved by the Medical Ethics Committee of Affiliated Hospital of Qinghai University of China in November 2017 (approval number 2017-11). The study protocol will be conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants who will be fully informed of study protocol and process. This trial was designed in December 2017. The recruitment of subjects and data collection will begin in July 2018. Outcome measures will be analyzed in September 2020. This trial will be completed in October 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial had been registered in the Chinese Clinical Trial Registry (registration NoChiCTR1800015411). The version of this study protocol is 1.0.