Abstract
A CaO-SiO(2)-P(2)O(5)-B(2)O(3) bioactive glass-ceramic (BGS-7) spacer provides high mechanical stability, produces a chemical bond to the adjacent endplate, and facilitates fusion after spine surgery. This prospective, randomized, single-blind, non-inferiority trial aimed to evaluate the radiographic outcomes and clinical efficacy of anterior cervical discectomy and fusion (ACDF) using a BGS-7 spacer for treating cervical degenerative disorders. Thirty-six patients underwent ACDF using a BGS-7 spacer (Group N), and 40 patients underwent ACDF using polyetheretherketone (PEEK) cages filled with a mixture of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP) for the treatment of cervical degenerative disorders. The spinal fusion rate was assessed 12 months postoperatively using three-dimensional computed tomography (CT) and dynamic radiographs. Clinical outcomes included patient-reported outcome measures, visual analog scale scores for neck and arm pain, and scores from the neck disability index (NDI), European Quality of Life-5 Dimensions (EQ-5D), and 12-item Short Form Survey (SF-12v2). All participants were randomly assigned to undergo ACDF using either a BGS-7 spacer or PEEK cage filled with HA and β-TCP. The primary outcome was the fusion rate on CT scan image at 12 months after ACDF surgery based on a per-protocol strategy. Clinical outcomes and adverse events were also assessed. The 12-month fusion rates for the BGS-7 and PEEK groups based on CT scans were 81.8% and 74.4%, respectively, while those based on dynamic radiographs were 78.1% and 73.7%, respectively, with no significant difference between the groups. There were no significant differences in the clinical outcomes between the two groups. Neck pain, arm pain, NDI, EQ-5D, and SF-12v2 scores significantly improved postoperatively, with no significant differences between the groups. No adverse events were observed in either group. In ACDF surgery, the BGS-7 spacer showed similar fusion rates and clinical outcomes as PEEK cages filled with HA and β-TCP.