Symptomatic ectopic bone formation after off-label use of recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion

J Neurosurg Spine. 2010 Jan;12(1):40-6. doi: 10.3171/2009.4.SPINE0876.

Abstract

Object: Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been approved for use in the lumbar spine in conjunction with the lumbar tapered cage. However, off-label use of this osteoinductive agent is observed with anterior fusion applications as well as with both posterior lumbar interbody fusion and transforaminal lumbar interbody fusion (TLIF). Complications using rhBMP-2 in the cervical spine have been reported. Although radiographic evidence of ectopic bone in the lumbar spine has been described following rhBMP-2 use, this finding was not previously believed to be of clinical relevance.

Methods: This study was a retrospective review of 4 patients who underwent minimally invasive spinal TLIF (MIS-TLIF) in which bone fusion was augmented with rhBMP-2 applied to an absorbable collagen sponge. Case presentations, operative findings, imaging data, and follow-up findings were reviewed.

Results: Four cases with delayed symptomatic neural compression following the off-label use of rhBMP-2 with MIS-TLIF were identified.

Conclusions: Although previously believed to be only a radiographic finding, the development of ectopic bone following rhBMP-2 use in lumbar fusion can be clinically significant. This paper describes 4 cases of delayed neural compression following MIS-TLIF. The reader should be aware of this potential complication following the off-label use of rhBMP-2 in the lumbar spine.

Publication types

  • Case Reports

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Bone Morphogenetic Protein 2 / adverse effects*
  • Bone Morphogenetic Protein 2 / therapeutic use
  • Diskectomy
  • Female
  • Follow-Up Studies
  • Humans
  • Intervertebral Disc Degeneration / diagnosis
  • Intervertebral Disc Degeneration / surgery*
  • Laminectomy
  • Lumbar Vertebrae / surgery*
  • Male
  • Middle Aged
  • Minimally Invasive Surgical Procedures
  • Myelography
  • Nerve Compression Syndromes / chemically induced
  • Nerve Compression Syndromes / diagnosis
  • Nerve Compression Syndromes / surgery
  • Off-Label Use*
  • Ossification, Heterotopic / chemically induced*
  • Ossification, Heterotopic / diagnosis
  • Ossification, Heterotopic / surgery
  • Postoperative Complications / chemically induced*
  • Postoperative Complications / diagnosis
  • Postoperative Complications / surgery
  • Prosthesis Implantation / methods*
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Reoperation
  • Spinal Fusion / methods*
  • Spinal Nerve Roots / surgery
  • Spondylolisthesis / diagnosis
  • Spondylolisthesis / surgery*
  • Tomography, X-Ray Computed

Substances

  • BMP2 protein, human
  • Bone Morphogenetic Protein 2
  • Recombinant Proteins