The Journal of Bone and Joint Surgery (American). 2009;91:1181-1189.
doi:10.2106/JBJS.G.01485
© 2009 The Journal of Bone and Joint Surgery, Inc.
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Six-Year Outcomes of Anterior Lumbar Interbody Arthrodesis with Use of Interbody Fusion Cages and Recombinant Human Bone Morphogenetic Protein-2

J. Kenneth Burkus, MD1, Matthew F. Gornet, MD2, Thomas C. Schuler, MD3, Thomas J. Kleeman, MD4 and Thomas A. Zdeblick, MD5

1 The Hughston Clinic, 6262 Veterans Parkway, Columbus, GA 31908. E-mail address: JKB66{at}knology.net
2 Spine Research Center, 14825 North Outer Forty Road, Suite 320, St. Louis, MO 63017
3 Virginia Spine Institute, 1831 Wiehle Avenue, Reston, VA 20190
4 New Hampshire NeuroSpine Institute, 4 Hawthorne Drive, Bedford, NH 03110
5 Department of Orthopedics and Rehabilitation, University of Wisconsin, 600 Highland Avenue, Suite K3705, Madison, WI 53792

Investigation performed at the Hughston Clinic, Columbus, Georgia; the Spine Research Center, St. Louis, Missouri; the Virginia Spine Institute, Reston, Virginia; the New Hampshire NeuroSpine Institute, Bedford, New Hampshire; and the Department of Orthopedics and Rehabilitation, University of Wisconsin, Madison, Wisconsin

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). No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

Background: Twenty-four-month outcomes have been reported for patients with degenerative lumbar disc disease who were treated with stand-alone anterior lumbar interbody arthrodesis with use of dual tapered interbody fusion cages and recombinant human bone morphogenetic protein-2. This report represents an update of the clinical and radiographic results of this treatment at six years.

Methods: Two hundred and seventy-seven patients with single-level degenerative disc disease with up to grade-I spondylolisthesis were enrolled in two prospective, multicenter, U.S. Food and Drug Administration-approved investigational device exemption studies and were treated with an open or a laparoscopic surgical procedure. The patients received recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with lumbar fusion cage implants. One hundred and forty-six patients completed the six-year clinical follow-up evaluations, and 130 patients had complete radiographic follow-up at six years. Outcomes were determined with use of well-established clinical outcome measurements (Oswestry Disability Index, Short Form-36, and back and leg pain scores) and radiographic assessments.

Results: At six years, 128 (98%) of the 130 patients treated with recombinant human bone morphogenetic protein-2 and stand-alone fusion cages had a fusion. The second surgery rate was 6.7% (eighteen patients) prior to two years and 3.7% (seven patients) from two to six years. A worst-case scenario analysis, which includes all second surgical procedures due to pseudarthrosis, resulted in a fusion rate at seventy-two months of 91% (128 of 141). Significant improvements in the Oswestry Disability Index scores, Short Form-36 health survey physical component summary scores, and back and leg pain scores were achieved by six weeks in both the open and laparoscopic groups and were sustained at six years (p < 0.001). The percentage of patients who were working at six months (63%) was higher than the percentage who had been working preoperatively (52%), and this improvement was sustained at six years (68%).

Conclusions: The use of dual tapered threaded fusion cages and recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge obtained and maintained intervertebral spinal fusion, improved clinical outcomes, and reduced pain after anterior lumbar interbody arthrodesis in patients with degenerative lumbar disc disease.

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


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