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. 2023 Jun 15;12(12):4069.
doi: 10.3390/jcm12124069.

Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial

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Anterior Cervical Discectomy and Fusion Performed Using a CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic or Polyetheretherketone Cage Filled with Hydroxyapatite/β-Tricalcium Phosphate: A Prospective Randomized Controlled Trial

Jiwon Park et al. J Clin Med. .

Abstract

A CaO-SiO2-P2O5-B2O3 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.

Keywords: ACDF; PEEK cage; cervical; fusion rate; glass ceramics.

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Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Photographs of implants: (A) CaO-SiO2-P2O5-B2O3 bioactive glass ceramic spacer (B) polyetheretherketone cage filled with hydroxyapatite/β-tricalcium phosphate.
Figure 2
Figure 2
Enrollment, randomization, treatment, and follow-up flow diagram.
Figure 3
Figure 3
Coronal and sagittal computed tomography scan taken 12 months postoperatively showed complete fusion of (A,B) group C and (C,D) group N.
Figure 4
Figure 4
The graph illustrates the absence of significant disparity in in fusion rate between the two groups 12-months postoperatively. The dashed line denotes a threshold for non-inferiority, set at a negative deviation of 15% from the reference value. Confirmation of the non-inferiority of bioactive glass ceramic spacer is achieved when the upper limit of the one-sided 95% confidence interval falls below the predetermined margin.
Figure 5
Figure 5
Changes in secondary outcomes between the two groups during the 12-month follow-up period. (A) Changes in mean VAS neck pain score, ranging from 0 (no pain) to 10 (worst pain). (B) Changes in mean VAS upper extremity pain score, ranging from 0 (no pain) to 10 (worst pain). (C) Changes in mean NDI score, ranging from 0 (no disability) to 100 (high disability). (D) Changes in mean EQ-5D value, ranging from 0 (worst quality of life) to 100 (best quality of life). (E) Changes in mean SF-12v2 PCS and (F) MCS score, with higher scores indicating better HRQOL. Error bars indicate 95% confidence intervals. VAS, visual analog scale; NDI, Neck disability index; EQ-5D, European Quality of Life-5 Dimensions; SF-12, 12-item short form health survey; PCS, physical component summary; MCS, mental component summary.

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Grants and funding

This research was partially supported by BioAlpha Incorporation in Republic of Korea. The funders had no role in the design and conduct of the study.

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