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Experimental Spinal Fusion With Recombinant Human Bone Morphogenetic Protein-2 Without Decortication of Osseous Elements

Sandhu, Harvinder S., MD*; Kanim, Linda E.A., MA*; Toth, Jeffrey M., PhD; Kabo, J. Michael, PhD*; Liu, David*; Delamarter, Rick B., MD*; Dawson, Edgar G., MD*

Basic Science

Study Design. L4-L5 intertransverse process fusions were produced with 58 μg, 230 μg, or 920 μg of recombinant human bone morphogenetic protein-2 in 20 dogs. Eleven had traditional decortication of posterior elements before insertion of the implant. Nine were left undecorticated. All animals were evaluated 3 months after surgery.

Objectives. To determine whether decortication is a prerequisite for successful fusion in the presence of osteoinductive proteins such as bone morphogenetic protein-2.

Summary of Background Data. Recombinant osteoinductive proteins can induce de novo bone in ectopic soft-tissue sites in the absence of bone marrow elements. Traditional methods for achieving spinal fusion rely on exposure of bone marrow through decortication to facilitate osteogenesis. It is hypothesized that the presence of an implanted osteoinductive protein obviates the need for exposure and release of host inductive factors.

Methods. Recombinant human bone morphogenetic protein-2-induced intertransverse process fusions were performed with and without decortication. Fusion sites were evaluated by computed tomography imaging, high-resolution radiography, manual testing, mechanical testing, and histologic analysis.

Results. One hundred percent of decorticated spines and 89% of undecorticated spines were clinically fused by 3 months. Ninety-one percent of decorticated spines and 78% of undecorticated specimens exhibited bilateral transverse process osseous bridging. The only spines that failed to achieve solid bilateral arthrodesis were in the lowest dose group. With the higher two doses, there was histologic evidence of osseous continuity between the fusion mass and undecorticated transverse processes.

Conclusions. There were no statistical differences in clinical and radiographic fusion rates between decorticated and undecorticated sites. With higher doses of recombinant human bone morphogenetic protein-2, there was little histologic distinction between fusions in decorticated versus undecorticated spines.

From the *Department of Orthopaedic Surgery and the UCLA Comprehensive Spine Center, UCLA School of Medicine, Los Angeles, California, and the Department of Orthopaedic Surgery, The Medical College of Wisconsin, Milwaukee, Wisconsin.

Presented in part at the 30th annual meeting of the Scoliosis Research Society, Asheville, North Carolina, September 13-17, 1995.

Supported by a research grant from Sofamor Danek USA, Memphis, Tennessee.

Acknowledgment date: October 4, 1995.

First revision date: December 19, 1995.

Second revision date: July 23, 1996.

Acceptance date: July 31, 1996.

Device Status Category: 7.

Address reprint requests to: Harvinder S. Sandhu, MD; Assistant Professor of Orthopaedic Surgery; UCLA School of Medicine; 200 UCLA Medical Plaza; Suite 140; Los Angeles, CA 90095-6902

© Lippincott-Raven Publishers.