Efficacy and safety of Escherichia coli-derived recombinant human bone morphogenetic protein-2 in additional lumbar posterolateral fusion: minimum 1-year follow-up

Abstract

Background context: Recombinant human bone morphogenetic protein-2 (BMP-2) is the growth factor with the most striking osteoinductive performance in orthopedic operations; it is also able to induce heterotopic bone formation. However, there has been little clinical research on Escherichia coli-derived BMP-2 (E.BMP-2).

Purpose: To confirm the efficacy and safety of E.BMP-2 with a hydroxyapatite carrier when applied to one-sided posterolateral fusion (PLF) in addition to lumbar interbody fusion (LIF), and to measure the lower dose of E.BMP-2 ever reported achieving solid fusion.

Study design/setting: Retrospective case-control study PATIENT SAMPLE: A total of 121 patients who received surgery for one or two levels of fusion for lumbar degenerative spinal stenosis or spondylolisthesis from January 2009 to December 2019 were included.

Outcome measures: Clinical and functional outcomes were evaluated using preoperative and final follow-up visual analogue scales for back pain (VAS-BP) and leg pain (VAS-LP), and Korean Oswestry disability index (K-ODI) scores. Fusion rates were evaluated by computed tomography at six months and one year after surgery. In addition, a subgroup analysis of group E according to number of fusion levels was conducted, and the fusion rates in the one-level and two-level fusion groups were compared.

Methods: LIF and additional one-sided PLF was performed in all patients. They received autogenous iliac bone grafts (Group C, n=69) or 1mg of E.BMP-2 (Group E, n=52).

Results: There were no significant differences between preoperative and final VAS-BP, VAS-LP and K-ODI. The PLF rate was 79.7% for Group C and 82.7% for Group E at postoperative six months, and 94.2% for Group C and 100% for Group E at postoperative one year (p =.679, 0.134, respectively). The LIF rate was 71.0% in Group C and 71.2% in Group E at six months after surgery, and 97.1% in Group C and 100% in Group E at one year (p =.987, 0.506, respectively). In terms of numbers of fusion levels in Group E, PLF rates at six months (p =.486) and one year after surgery were similar in the two groups, as were LIF rates at six months (p =.822) and one year after surgery. There were no cases of malignancy or radiculopathy in Group E during one-year of follow-up.

Conclusions: One milligram of E.BMP-2 is a safe and effective osteoinductive material in short-level lumbar PLF surgery.

Keywords: Efficacy; Escherichia coli-derived BMP-2; Lumbar spinal stenosis; Posterolateral fusion; Safety.