The Journal of Bone and Joint Surgery (American). 2005;87:1205-1212.
doi:10.2106/JBJS.D.02532
© 2005 The Journal of Bone and Joint Surgery, Inc.
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Use of rhBMP-2 in Combination with Structural Cortical Allografts: Clinical and Radiographic Outcomes in Anterior Lumbar Spinal Surgery

J. Kenneth Burkus, MD1, Harvinder S. Sandhu, MD2, Matthew F. Gornet, MD3 and Michael C. Longley, MD4

1 Wilderness Spine Services, The Hughston Clinic, 6262 Veterans Parkway, Columbus, GA 31909. E-mail address: jkb66{at}knology.net
2 Weill Medical College, Cornell University, 523 East 72nd Street, New York, NY 10021
3 The Orthopedic Center of St. Louis, 10 Barnes West Drive, Suite 200, St. Louis, MO 63141
4 Nebraska Spine Center, 11819 Miracle Hills Drive, #102, Omaha, NE 68154

Investigation performed at the Hughston Clinic, Columbus, Georgia, the Orthopedic Center of St. Louis, St. Louis, Missouri, and the Nebraska Spine Center, Omaha, Nebraska

Background: Recombinant human bone morphogenetic protein-2 soaked into an absorbable collagen sponge (rhBMP-2/ACS) has been shown in a nonhuman primate study and in a pilot study in humans to promote new bone formation and incorporation of an allograft device when implanted in patients undergoing anterior lumbar interbody arthrodesis. However, a larger series with longer follow-up is needed to demonstrate its superiority to autogenous iliac crest bone graft.

Methods: Between 1998 and 2001, a two-part, prospective, randomized, multicenter study of 131 patients was conducted to determine the safety and efficacy of the use of rhBMP-2/ACS as a replacement for autogenous iliac crest bone graft in anterior lumbar spinal arthrodesis with threaded cortical allograft dowels. Patients were randomly assigned to a study group that received rhBMP-2/ACS or to a control group that received autograft. The clinical and radiographic outcomes were determined with use of well-established instruments and radiographic assessments.

Results: The patients in the study group had significantly better outcomes than the control group with regard to the average length of surgery (p < 0.001), blood loss (p < 0.001), and hospital stay (p = 0.020). Fusion rates were significantly better in the study group (p < 0.001). The average Oswestry Disability Index scores, Short-Form-36 physical component summary scores, and low-back and leg-pain scores were significantly better in the study group (p < 0.05).

Conclusions: In patients undergoing anterior lumbar interbody arthrodesis with threaded allograft cortical bone dowels, rhBMP-2/ACS was an effective replacement for autogenous bone graft and eliminated the morbidity associated with graft harvesting.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.


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Letters to the Editor:

Read all Letters to the Editor

Unexplained Decreasing of rhBMP-2 Dose
Tomislav Smoljanovic, M.D., et al.
JBJS Online, 23 Oct 2007 [Full text]
Continuing Questions Regarding Adverse Effects Of Spinal Interbody Fusion Using rhBMP-2/ACS
Tomislav Smoljanovic, MD, PhD, et al.
JBJS Online, 24 Feb 2009 [Full text]
Dr. Burkus and colleagues respond to Dr. Smoljanovic and colleagues
J. Kenneth Burkus, MD, et al.
JBJS Online, 19 Mar 2009 [Full text]