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A Prospective, Randomized, Controlled, Multicenter Study of Osteogenic Protein-1 in Instrumented Posterolateral Fusions: Report on Safety and Feasibility

Delawi, D., MD*; Dhert, W. J. A., MD, PhD*; Rillardon, L., MD; Gay, E., MD, PhD; Prestamburgo, D., MD§; Garcia-Fernandez, C., MD; Guerado, E., MD; Specchia, N., MD**; Van Susante, J. L. C., MD, PhD††; Verschoor, N., MD‡‡; van Ufford, H. M. E. Quarles, MD, PhD§§; Oner, F. C., MD, PhD*

doi: 10.1097/BRS.0b013e3181d3cf28
Randomized Trial
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Study Design. A prospective, randomized, controlled, multicenter clinical study.

Objective. To evaluate the safety and feasibility of osteogenic protein (OP)-1 in 1-level lumbar spine instrumented posterolateral fusions.

Summary of Background Data. Instrumented posterolateral fusion with the use of autograft is a commonly performed procedure for a variety of spinal disorders. However, harvesting of bone from the iliac crest is associated with complications. A promising alternative for autograft are bone morphogenetic proteins.

Methods. As part of a larger prospective, randomized, multicenter study, 36 patients were included, who received a 1-level instrumented posterolateral fusion of the lumbar spine. All patients had a degenerative or isthmic spondylolisthesis with symptoms of neurologic compression. There were 2 treatment arms: OP-1 combined with locally available bone from laminectomy (OP-1 group) or iliac crest autograft (autograft group). The primary outcome was the fusion rate based on a computed tomography scan after 1-year follow-up. The clinical outcome was measured using the Oswestry Disability Index. Additionally, the safety of OP-1 was evaluated by comparing the number and severity of adverse events that occurred between both groups.

Results. Using strict criteria, fusion rates of 63% were found in the OP-1 group and 67% in the control group (P = 0.95). There was a decrease in Oswestry scores at subsequent postoperative time points compared with preoperative values (P > 0.001). There were no significant differences in the mean Oswestry scores between the study group and control group at any time point (P = 0.56). No product-related adverse events occurred.

Conclusion. The results demonstrate that OP-1 combined with locally obtained autograft is a safe and effective alternative for iliac crest autograft in instrumented single-level posterolateral fusions of the lumbar spine. The main advantage of OP-1 is that it avoids morbidity associated with the harvesting of autogenous bone grafts from the iliac crest.

This European multicenter study compares the safety and efficacy of osteogenic protein (OP)-1 to iliac crest autograft in instrumented posterolateral fusions. The results show that OP-1 is a safe and effective alternative for this indication. The main advantage of OP-1 is that it avoids iliac crest donor site morbidity.

From the *Department of Orthopaedics, University Medical Center Utrecht, Utrecht, The Netherlands; †Department of Orthopaedics, Hopital Beaujon, Clichy, France; ‡Department of Neurosurgery, Hopital La Tronche, Grenoble, France; §Department of Orthopaedic and Traumatology, Ospedale di Circolo, Varese, Italy; ¶Department of Orthopaedic Surgery and Traumatology, Hospital Clinico San Carlos, Madrid, Spain; ∥Department of Orthopaedic Surgery and Traumatology, Hospital Costa del Sol, Marbella, Spain; **Department of Orthopaedic Surgery and Traumatology, Ospedale Ruiniti di Ancona, Ancona, Italy; ††Department of Orthopaedics, Rijnstate, Arnhem, The Netherlands; ‡‡Department of Orthopaedics, Jeroen Bosch Ziekenhuis, Den Bosch, The Netherlands; and §§Department of Radiology, University Medical Center Utrecht, Utrecht, The Netherlands.

Acknowledgment date: December 15, 2008. Revision date: May 17, 2009. Acceptance date: August 10, 2009.

The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA-approved for this indication and is/are commercially available in the United States for other indications.

Corporate/Industry and Institutional funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

Address correspondence and reprint requests to F. C. Oner, MD, PhD, Department of Orthopaedics, University Medical Center Utrecht, P.O. Box 85500, G05.228, 3508 GA Utrecht, The Netherlands; E-mail: f.c.oner@umcutrecht.nl

© 2010 Lippincott Williams & Wilkins, Inc.