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Use of rhBMP-2 in Combination with Structural Cortical Allografts: Clinical and Radiographic Outcomes in Anterior Lumbar Spinal Surgery

Burkus, J. Kenneth MD; Sandhu, Harvinder S. MD; Gornet, Matthew F. MD; Longley, Michael C. MD

Journal of Bone & Joint Surgery - American Volume: June 2005 - Volume 87 - Issue 6 - p 1205–1212
doi: 10.2106/JBJS.D.02532
Scientific Articles

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.

1 Wilderness Spine Services, The Hughston Clinic, 6262 Veterans Parkway, Columbus, GA 31909. E-mail address: jkb66@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

Copyright 2005 by The Journal of Bone and Joint Surgery, Incorporated
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