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Purpose <p>Minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) offers advantages over open procedures but is limited by the reduced availability of autologous bone. <i>Escherichia coli</i>–derived recombinant human bone morphogenetic protein-2 (E.BMP-2) has emerged as a scalable osteoinductive alternative, though its application in MIS-TLIF remains unstudied. This study aimed to evaluate the efficacy and safety of E.BMP-2 combined with hydroxyapatite (HA) carriers in the context of MIS-TLIF.</p> Methods <p>Seventy patients (85 fusion levels) who underwent one- or two-level MIS-TLIF for degenerative lumbar conditions between 2016 and 2024 were included, with a minimum follow-up of one year. The E.BMP-2 group (34 patients, 39 levels) received local bone graft and allogenic cancellous bone graft along with a fixed dose of 1&#xa0;mg E.BMP-2. The control group (36 patients, 46 levels) received local bone graft and allogenic cancellous bone graft only. Fusion was assessed using dynamic radiographs and CT imaging. Solid fusion on radiographs was defined as segmental motion &lt; 3°, and on CT as continuous trabecular bone bridging between the upper and lower endplates. Clinical outcomes were evaluated using the visual analog scale (VAS) for back and leg pain, the Oswestry Disability Index (ODI), and the Functional Rating Index (FRI). Perioperative and delayed complications—including fever, elevated inflammatory markers, seroma formation, heterotopic ossification, and cage subsidence—were assessed via imaging and medical records.</p> Results <p>The E.BMP-2 group demonstrated significantly higher fusion rates (radiographs: 97.4% vs. 78.3%, <i>p</i> = 0.001; CT: 89.7% vs. 63.0%, <i>p</i> = 0.005) without an increase in complications. No cases of seroma, heterotopic ossification, or reoperation were observed in the E.BMP-2 group. A standardized application protocol using 1&#xa0;mg of E.BMP-2 per patient, combined with a containment technique, likely contributed to these favorable outcomes. Although clinical improvements were similar between groups, the rate of cage subsidence was significantly lower in the E.BMP-2 group at 6 and 12 months.</p> Conclusion <p>Low-dose E.BMP-2 appears to be a safe and effective osteoinductive adjunct for MIS-TLIF, particularly in cases with limited autologous bone. Appropriate carrier selection, dosing, and containment techniques are key to optimizing outcomes.</p>

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Efficacy of low-dose Escherichia coli-derived recombinant human bone morphogenetic protein-2 in minimally invasive transforaminal lumbar interbody fusion

  • 期刊论文

  • 发表日期：

    2025年11月29日

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  • Tae Hoon Kang,
  • Jeongwoon Han,
  • Minjoon Cho,
  • Jae Hyup Lee

摘要

Purpose

Minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) offers advantages over open procedures but is limited by the reduced availability of autologous bone. Escherichia coli–derived recombinant human bone morphogenetic protein-2 (E.BMP-2) has emerged as a scalable osteoinductive alternative, though its application in MIS-TLIF remains unstudied. This study aimed to evaluate the efficacy and safety of E.BMP-2 combined with hydroxyapatite (HA) carriers in the context of MIS-TLIF.

Methods

Seventy patients (85 fusion levels) who underwent one- or two-level MIS-TLIF for degenerative lumbar conditions between 2016 and 2024 were included, with a minimum follow-up of one year. The E.BMP-2 group (34 patients, 39 levels) received local bone graft and allogenic cancellous bone graft along with a fixed dose of 1 mg E.BMP-2. The control group (36 patients, 46 levels) received local bone graft and allogenic cancellous bone graft only. Fusion was assessed using dynamic radiographs and CT imaging. Solid fusion on radiographs was defined as segmental motion < 3°, and on CT as continuous trabecular bone bridging between the upper and lower endplates. Clinical outcomes were evaluated using the visual analog scale (VAS) for back and leg pain, the Oswestry Disability Index (ODI), and the Functional Rating Index (FRI). Perioperative and delayed complications—including fever, elevated inflammatory markers, seroma formation, heterotopic ossification, and cage subsidence—were assessed via imaging and medical records.

Results

The E.BMP-2 group demonstrated significantly higher fusion rates (radiographs: 97.4% vs. 78.3%, p = 0.001; CT: 89.7% vs. 63.0%, p = 0.005) without an increase in complications. No cases of seroma, heterotopic ossification, or reoperation were observed in the E.BMP-2 group. A standardized application protocol using 1 mg of E.BMP-2 per patient, combined with a containment technique, likely contributed to these favorable outcomes. Although clinical improvements were similar between groups, the rate of cage subsidence was significantly lower in the E.BMP-2 group at 6 and 12 months.

Conclusion

Low-dose E.BMP-2 appears to be a safe and effective osteoinductive adjunct for MIS-TLIF, particularly in cases with limited autologous bone. Appropriate carrier selection, dosing, and containment techniques are key to optimizing outcomes.