Fusion quality of E.BMP-2/HA superior to auto-iliac bone graft in lumbar posterolateral fusion

Minjoon Cho et al conducted a study to evaluate the mid-term efficacy and safety of Escherichia coli-derived bone morphogenetic protein-2 (E.BMP 2)/ hydroxyapatite (HA) in lumbar posterolateral fusion (PLF). The study has been published in European Spine Journal.

This multicenter, evaluator-blinded, observational study utilized prospectively collected clinical data. 74 patients who underwent lumbar PLF were enrolled and had previously participated in the BA06-CP01 clinical study, which compared the short-term outcomes of E.BMP-2 with an auto-iliac bone graft (AIBG).

The authors’ procedure - Lumbar PLF was performed routinely. Following the posterior midline approach, decompression with laminectomy and flavectomy was performed. Pedicle screw fixation was performed at the involved level and the allocated bone graft materials were applied between the two transverse processes.

In the E.BMP-2 group, they used Novosis (CG Bio Co., Ltd., Seoul, Korea), an E. coli-derived rhBMP-2 with an HA carrier. Approximately 3 g (8 cc) of HA was soaked in one vial (3.0 mg) of E.BMP-2 and carefully applied in the inter-transverse space. This process was repeated on the contralateral side.

In the AIBG group, approximately 8 cc of auto-iliac bone graft was applied on each side.

Bone grafts obtained via laminectomy were not used in either group.

Radiographs and CT scans were analyzed to evaluate fusion grade at 12, 24, and 36 months. Visual analog scale (VAS), Oswestry disability index (ODI), and Short Form-36 (SF-36) scores were measured preoperatively and at 36 months after surgery. All adverse events in this study were assessed for its relationship with E.BMP-2.

Key findings of the study were:

• The fusion grade of the E.BMP-2 group (4.91±0.41) was superior to that of the AIBG group (4.25±1.26) in CT scans at 36 months after surgery (p=0.007).

• Non-union cases were 4.3% in the E.BMP-2 and 16.7% in the AIBG.

• Both groups showed improvement in pain VAS, ODI, and SF-36 scores when compared to the baseline values, and there were no statistically significant differences between the two groups.

• No treatment-related serious adverse reactions were observed in either group.

• No neoplasm-related adverse events occurred in the E.BMP-2 group.

The authors concluded that – “E.BMP-2/HA showed a comparable efficacy and safety in the mid-term follow-up compared with AIBG in single-segment posterolateral fusion. E.BMP-2/HA can be a satisfactory alternative to AIBG in patients who require fast and solid fusion.”

Further reading:

Mid term efficacy and safety of Escherichia coli derived rhBMP 2/ hydroxyapatite carrier in lumbar posterolateral fusion: a randomized, multicenter study

Minjoon Cho, KI Han You et al European Spine Journal https://doi.org/10.1007/s00586-022-07440-3