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Complications Associated With the Use of the Recombinant Human Bone Morphogenetic Proteins for Posterior Interbody Fusions of the Lumbar Spine

Chrastil, Jesse MD*; Low, Jeffrey B. BA; Whang, Peter G. MD, FACS; Patel, Alpesh A. MD, FACS

doi: 10.1097/BRS.0b013e3182982f8e
Literature Review

Study Design. Systematic review.

Objective. The objectives of this review are to examine the spectrum of complications that have been reported in the literature after posterior interbody fusions of the lumbar spine augmented with bone morphogenetic proteins (BMPs) and discuss potential methods for their prevention.

Summary of Background Data. The use of BMPs for spinal arthrodesis procedures has increased dramatically during the past decade. These products are commonly used in “off-label” fashion in posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) constructs. Recently, a number of adverse events have been attributed to the use of BMP for PLIF and TLIF surgical procedure, including heterotopic ossification within the epidural space or neuroforamina, postoperative radiculitis, and endplate osteolysis with interbody device subsidence.

Methods. A computer aided literature search was performed on the electronic databases PubMed, MEDLINE, EMBASE, CINAHL, and Cochrane Database of Systematic Reviews. Key words of interest included BMPs, PLIF, TLIF, complications, heterotopic ossification, radiculitis, and osteolysis. All articles, in the English language, between 1990 and 2011 were considered relating to the use of BMPs in PLIF and TLIF constructs.

Results. Seventeen articles discussing the use and potential complications of BMPs in PLIF and TLIF constructs were identified and reviewed. The studies were in the range of a level I prospective randomized trial to case reports of complications. There is a wide variation of published complications associated with BMP-augmented PLIF and TLIF constructs.

Conclusion. Despite high fusion rates there is a growing body of evidence that the use of BMP in PLIF and TLIF constructs does not come without potential complication. There are appreciable rates of BMP-specific complications, which include heterotopic ossification within the epidural space or neuroforamina, postoperative radiculitis, and endplate osteolysis with interbody device subsidence.

Level of Evidence: 2

Bone morphogenetic proteins are used “off-label” in a high percentage of posterior lumbar and transforaminal lumbar interbody fusions. There have been several documented complications associated with bone morphogenetic protein including heterotopic ossification, postoperative radiculitis, and endplate osteolysis with interbody device subsidence. This literature review identifies and discusses these complications.

*Resident Physician, Department of Orthopaedics, University of Utah, Salt Lake City, UT

Department of Orthopaedics and Rehabilitation, Yale University School of Medicine, New Haven, CT; and

Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.

Address correspondence and reprint requests to Alpesh A. Patel, MD, FACS, Department of Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, 676 N. Saint Clair St, Ste 1350, Chicago IL; E-mail: alpesh.patel@northwestern.edu

Acknowledgment date: July 23, 2012. First revision date: March 5, 2013. Second revision date: April 4, 2013. Acceptance date: April 10, 2013.

The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are not commercially available in the United States.

No funds were received in support of this work.

Relevant financial activities outside the submitted work: board membership, consultancy, royalties, payment for lecture, patents, payment for development of educational presentations, stocks.

© 2013 by Lippincott Williams & Wilkins