A Long-Term Follow-up, Multicenter, Comparative Study of the Radiologic, and Clinical Results Between a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramics (BGS-7) Intervertebral Spacer and Titanium Cage in 1-Level Posterior Lumbar Interbody Fusion.

Study Design: This is a prospective, stratified randomized, multicenter, 4-year follow-up study.

Objective: The authors aimed to evaluate the long-term clinical efficacy and safety of CaO-SiO2-P2O5-B2O3 glass ceramics (BGS-7) spacers in 1-level posterior lumbar interbody fusion (PLIF) at a 4-year follow-up.

Summary Of Background Data: According to 1-year follow-up results, BGS-7 spacer showed similar fusion rates and clinical outcomes compared with titanium cage. A long-term follow-up study beyond 2 years is necessary to investigate the status of intervertebral bone graft volumes. Moreover, longer follow-up is mandatory to also evaluate the safety and efficacy of BGS-7 spacers, because they remain in the intervertebral space for a long time.

Materials And Methods: In this prospective, randomized, multicenter, 4-year follow-up study, we evaluated 62 of the 74 patients who underwent 1-level PLIF. During 1-level PLIF, titanium cages filled with autologous local bone were inserted into the control group patients and BGS-7 spacers were inserted to the experimental group patients. Bone fusion was evaluated by plain radiography and thin-section computed tomography. Visual Analog Scale (VAS), the Oswestry Disability Index (ODI), Short Form-36 Health Survey (SF-36), and evaluation of safety were conducted after 48 months.

Results: Computed tomography scan showed a bone fusion rate of 90.6% in the BGS-7 spacer group and 93.3% in the control group, with no significant differences between groups. The BGS-7 spacer group showed a significantly larger area directly fused to the endplate than the control group (P<0.001). The BGS-7 spacer group showed a significant increase in the fused area compared with the titanium group at 1- and 4-year follow-up. The ODI, SF-36, back pain, and lower limb pain in both groups showed significant improvement after surgery, and no significant differences were observed between the groups. Both groups showed no additional adverse events.

Conclusions: The 4-year follow-up study showed similar fusion rates and clinical outcomes in both the BGS-7 spacer and autologous bone with a titanium cage in 1-level PLIF. However, the BGS-7 spacer implants showed a larger area of fusion with the endplates than that of autologous bone with a titanium cage. Therefore, the results demonstrated that the BGS-7 spacer can be considered as a novel intervertebral spacer to achieve successful spinal fusion without safety concerns for long-term use.