Long-term effects of inorganic osteogenesis-inducing scaffold versus autologous bone in lumbar interbody fusion: protocol for a non-randomized, controlled trial with 2-year follow-up

doi:10.3969/j.issn.2095-4344.1751

Abstract

Abstract:

BACKGROUND: Preliminary study has shown that inorganic osteogenesis-inducing scaffold material exhibits good biocompatibility and bone-inducing effects in posterior lumbar interbody fusion, with encouraging short-term outcomes.

OBJECTIVE: To investigate the safety and long-term effects of inorganic osteogenesis-inducing scaffold materials versus autologous ilium in lumbar interbody fusion.

METHODS: This prospective, single-center, non-randomized, controlled trial will include 120 patients who receive treatment for lumbar degenerative diseases at the Department of Orthopedics, Beijing Tongren Hospital, Capital Medical University, China. These patients will receive lumbar repair surgery with inorganic osteogenesis-inducing scaffold materials (test group, n=60, 50%) or autologous ilium (control group, n=60, 50%). All patients will be followed up at 1 week, and 1 and 2 years postoperatively. This study was approved by the Medical Ethics Committee, Beijing Tongren Hospital, Capital Medical University, China (approval No. TRECKY2017-158) on September 28, 2017. Study protocol version: 1.0. All participants or their family members must provide written informed consent after fully understanding the study protocol. The study was registered with Chinese Clinical Trial Registry on February 15, 2019 (registration number: ChiCTR1900021333). Study protocol version: 1.0. Patient recruitment bengun and the results will be disseminated through presentations at scientific meetings.

RESULTS AND CONCLUSION: The primary outcome measure of this study is the Oswestry Disability Index at 2 years postoperatively. The secondary outcome measures are the Oswestry Disability Index preoperatively and at 1 week and 1 year postoperatively, the Visual Analog Scale score, Japanese Orthopedic Association score, and lumbosacral angle preoperatively and at 1 week, and 1 and 2 years postoperatively, and the incidence of adverse reactions at 1 week, and 1 and 2 years postoperatively. This study will provide evidence to validate whether inorganic osteogenesis-inducing scaffold material results in similar long-term outcomes to autologous ilium in lumbar interbody fusion.

Key words: lumbar degenerative diseases, posterior lumbar interbody fusion, lumbar interbody fusion, inorganic osteogenesis-inducing scaffold material, tissue engineering

CLC Number:

Xue Zhixing, Zhou Jianwei, Chi Cheng, Wang Fei, Ma Yuquan. Long-term effects of inorganic osteogenesis-inducing scaffold versus autologous bone in lumbar interbody fusion: protocol for a non-randomized, controlled trial with 2-year follow-up [J]. Chinese Journal of Tissue Engineering Research, 2019, 23(22): 3518-3521.

Figures/Tables 1

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