Feasibility and safety of a CaO-SiO2-P2O5-B2O3 bioactive glass ceramic spacer in posterior lumbar interbody fusion compared with polyetheretherketone cage: a prospective randomized controlled trial.

PURPOSE: The CaO-SiO2-P2O5-B2O3 glass-ceramic (BGS-7) spacer is a recently developed spacer that shows chemical bonding to bone with high mechanical stability. Further, this spacer achieves similar results to those of titanium cages. However, evidence regarding the advantages of the BGS-7 spacer is weak compared to polyetheretherketone (PEEK) cage. A randomized controlled trial is therefore warranted. The purpose of this study was to compare the radiographic and clinical efficacies and safety of the BGS-7 spacer compared to those of the PEEK cage in patients who underwent posterior lumbar interbody fusion (PLIF). METHODS: The 54 participants who required one- or two-level PLIF due to lumbar degenerative disorders were randomly assigned to receive a BGS-7 spacer or PEEK cage. Visual analog scale (VAS), Oswestry Disability Index (ODI), European Quality of Life-5 Dimensions (EQ-5D), and painDETECT score were evaluated before surgery and at 3, 6, and 12 months after surgery. The fusion rate, degree of osteolysis, cage migration, and subsidence around the cage (spacer) were evaluated on computer tomography (CT) images at 12 months after surgery. RESULTS: The 12-month fusion rates were 77.8% in the BGS-7 spacer group and 81.0% in the PEEK cage group, with no significant difference (p = 0.807). The result regarding the non-inferiority of BGS-7 spacer was inconclusive. The linear mixed model showed no significant intervention effect in VAS, ODI, EQ-5D, and painDETECT score at the 3-, 6-, or 12-month follow-up. In addition, we found no significant between-group differences in the extent of osteolysis, spacer migration. However, the subsidence around the cage was significantly lower in the BGS-7 spacer group. CONCLUSIONS: This trial found similar fusion rates, and clinicoradiographic outcomes between the BGS-7 spacer and PEEK cage for PLIF. However, the non-inferiority was inconclusive. Safety concerns regarding fracture and migration of the BGS-7 spacer must be considered. Thus, the BGS-7 spacer design for PLIF surgery should be modified before further clinical use.