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

• Published in: Spine (Philadelphia, Pa. 1976) Pa. 1976), 2010-05, Vol.35 (12), p.1185-1191
• Main Authors: DELAWI, D, DHERT, W. J. A, QUARLES VAN UFFORD, H. M. E, ONER, F. C, RILLARDON, L, GAY, E, PRESTAMBURGO, D, GARCIA-FERNANDEZ, C, GUERADO, E, SPECCHIA, N, VAN SUSANTE, J. L. C, VERSCHOOR, N
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biological and medical sciences; Bone Morphogenetic Protein 7 - administration & dosage; Bone Morphogenetic Protein 7 - adverse effects; Bone Transplantation - adverse effects; Bone Transplantation - methods; Cerebrospinal fluid. Meninges. Spinal cord; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases; Feasibility Studies; Female; Follow-Up Studies; Hematoma - chemically induced; Hematoma - etiology; Humans; Ilium - transplantation; Lumbar Vertebrae - pathology; Lumbar Vertebrae - surgery; Male; Medical sciences; Middle Aged; Nervous system (semeiology, syndromes); Neurology; Pilot Projects; Prospective Studies; Spinal Fusion - adverse effects; Spinal Fusion - instrumentation; Spinal Fusion - methods; Spondylolisthesis - drug therapy; Spondylolisthesis - surgery; Transplantation, Autologous; Treatment Outcome
• ISSN: 0362-2436; 1528-1159
• DOI: 10.1097/BRS.0b013e3181d3cf28

A prospective, randomized, controlled, multicenter clinical study. To evaluate the safety and feasibility of osteogenic protein (OP)-1 in 1-level lumbar spine instrumented posterolateral fusions. 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. 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. 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. 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.