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Posterolateral lumbar fusion results similar between E.BMP-2, autogenous bone graft
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The fusion rate of Escherichia coli-derived recombinant human bone morphogenetic protein-2 following posterolateral lumbar fusion was similar to autogenous iliac bone graft, according to a recently published study.
Researchers identified 93 patients who underwent either single-level lumbar or lumbosacral posterolateral fusion and randomly assigned patients to receive either Escherichia coli-derived recombinant human bone morphogenetic protein-2 (E.BMP-2) with a hydroxyapatite carrier, or autogenous iliac bone graft. Preoperatively and at 12 weeks and 24 weeks postoperatively, investigators obtained thin-section CTs, VAS, Oswestry Disability Index (ODI) and SF-36. Then they compared outcome measures between the two groups.
Results showed there were no differences between the treatment groups regarding the preoperative demographic and clinical data. Investigators noted that at 12 weeks, patients who received E.BMP-2 had a CT-based fusion rate 100% and those who received autogenous iliac bone graft had a rate of 90.2%%. At 24 weeks, rates were 100% in the E.BMP-2 group and 94.1% in the autogenous iliac bone graft cohort. Based on radiographs and CT, fusion grade showed non-inferiority in patients who received E.BMP-2 vs. those who received autogenous iliac bone graft. Researchers observed improvements in all clinical parameters after surgery. Groups were not different regarding VAS, ODI and SF-36. There were no serious adverse events seen with E.BMP-2. – by Monica Jaramillo
Disclosures: Cho reports he receives a grant from Cg Bio/BioAlpha Inc. Please see the full study for a list of all other authors’ relevant financial disclosures.
Perspective
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Scott D. Boden, MD
This paper provides clinical results with E. coli-derived rhBMP-2, rather than recombinant protein derived from mammalian cells. Although safety does not appear to be an issue, there are several concerns that could question the reliability of the efficacy conclusions. These limitations include: 1) a relatively short follow-up period (24 weeks), during which 100% fusion success would not be expected for rhBMP-2; low BMP concentration (0.375 mg/cc), which is much lower than previously successful primate preclinical and clinical studies; and 3) the challenges of evaluating fusion status, even by CT scan, in the presence of radiopaque HA carrier.
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