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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

  • Original Article - Spine - Other
  • Published:
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Abstract

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.

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Data Availability

Access to the data set is provided only to the Data Management Committee of the Korean Government Research Consortium.

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Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was partially supported to cover research nurses by research grants ($17,895) from CGBio Incorporation in Republic of Korea.

Author information

Author notes

  1. Byung-Taek Kwon and Ho-Joong Kim equally contributed to this work.

Authors and Affiliations

  1. Department of Orthopaedic Surgery, Myongji Hospital, Hanyang University Medical Center, Goyang, Republic of Korea

    Byung-Taek Kwon

  2. Spine Center and Department of Orthopaedic Surgery, Seoul National University College of Medicine and Seoul National University Bundang Hospital, Seongnam, Republic of Korea

    Ho-Joong Kim, Sanghoon Lee, Sang-Min Park, Ohsang Kwon & Jin S. Yeom

  3. Department of Orthopedic Surgery, Chung-Ang University College of Medicine and Chung-Ang University Hospital, Seoul, Republic of Korea

    Dae-Woong Ham

  4. Department of Orthopedic Surgery, Spine Center, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, 82, Gumi-Ro 173 Beon-Gil, Bundang-Gu, Seongnam-Si, Gyeonggi-Do, 13620, Republic of Korea

    Hyun-Jin Park

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Corresponding author

Correspondence to Sang-Min Park.

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Ethics approval

This prospective, randomized, non-inferiority clinical trial was approved by the institutional review board of our hospital (B-1708/412–004) and was conducted according to the tenets of the 1964 Helsinki Declaration and its later amendments. The trial was registered at ClinicalTrials.gov as NCT03302520. All participants provided written informed consent before enrollment.

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The authors declare no competing interests.

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This manuscript was previously posted to Reaserchgate: https://doi.org/10.21203/rs.3.rs-927349/v1

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Kwon, BT., Kim, HJ., Lee, S. et al. 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. Acta Neurochir 165, 135–144 (2023). https://doi.org/10.1007/s00701-022-05429-x

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