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Scientific Articles   |    
Recombinant Human Bone Morphogenetic Protein-2 on an Absorbable Collagen Sponge with an Osteoconductive Bulking Agent in Posterolateral Arthrodesis with InstrumentationA Prospective Randomized Trial
Edgar Dawson, MD1; Hyun W. Bae, MD2; J. Kenneth Burkus, MD3; Jeffery L. Stambough, MD4; Steven D. Glassman, MD5
1 Deceased
2 Spine Research Foundation, The Spine Institute, 1301 20th Street, Suite 400, Santa Monica, CA 90404
3 The Hughston Clinic, 6262 Veterans Parkway, Columbus, GA 31908-9517. E-mail address: JKB66@knology.net
4 Tristate Orthopaedic Treatment Center, 4600 Smith Road, Cincinnati, OH 45212
5 Spine Institute, 210 East Gray Street, Suite 900, Louisville, KY 40202
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Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Medtronic Sofamor Danek. In addition, one or more of the authors or a member of his or her immediate family received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from a commercial entity (Medtronic Sofamor Danek). Also, a commercial entity (Medtronic Sofamor Danek) paid or directed in any one year, or agreed to pay or direct, benefits in excess of $10,000 to a research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which one or more of the authors, or a member of his or her immediate family, is affiliated or associated.
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The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2009 Jul 01;91(7):1604-1613. doi: 10.2106/JBJS.G.01157
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Abstract

Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge has been shown to be a safe and effective replacement for iliac crest bone graft when used with a threaded fusion device in anterior lumbar interbody arthrodesis. Use of rhBMP-2 on an absorbable collagen sponge in posterolateral lumbar arthrodesis requires the addition of a bulking agent to provide resistance against compression and to serve as an osteoconductive scaffold for new bone formation.

Methods: We performed a prospective, randomized, multicenter pilot study to investigate the use of rhBMP-2 on an absorbable collagen sponge combined with a ceramic-granule bulking agent as a replacement for autogenous iliac crest bone graft in single-level posterolateral lumbar arthrodesis with instrumentation. The investigational group (twenty-five patients) was treated with a 1.5 mg/mL solution of rhBMP-2 on two strips of absorbable collagen sponge (total dose of rhBMP-2, 12 mg) combined with 10 cm3 of ceramic granules. The control group (twenty-one patients) received iliac crest bone graft. Clinical outcomes were assessed with use of well-established instruments. Radiographs were reviewed to assess consolidation of fusion.

Results: Eighty-eight percent (twenty-two) of the twenty-five patients in the investigational group and 86% (eighteen) of the twenty-one patients in the control group were considered to have completed the twenty-four-month follow-up. At all follow-up intervals, there were significant improvements in the clinical outcome measures, including the Oswestry Disability Index (ODI) scores, Short Form-36 scores, and back and leg pain scores, in both groups. At twenty-four months, the improvement in the mean ODI score, as compared with the preoperative score, was 28.2 points in the investigational group and 23.0 points in the control group. By twenty-four months, 95% (eighteen) of nineteen patients in the investigational group compared with 70% (fourteen) of twenty in the control group had a radiographically documented fusion. The overall success rate was 81% (seventeen of twenty-one) in the investigational group and 55% (eleven of twenty) in the control group (p = 0.345).

Conclusions: Compared with an iliac crest bone graft, the combination of an absorbable collagen sponge soaked with rhBMP-2 and ceramic granules resulted in trends toward improvements in clinical outcomes and toward a higher rate of radiographic fusion. This combination of an osteoinductive agent with an osteoconductive matrix may be an effective replacement for autograft in single-level posterolateral lumbar arthrodeses with instrumentation.

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

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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