1. A Prospective, Randomized, Controlled, Multicenter Study of Osteogenic Protein-1 in Instrumented Posterolateral Fusions
- Author
-
D. Delawi, W. J. A. Dhert, L. Rillardon, E. Gay, D. Prestamburgo, C. Garcia-Fernandez, E. Guerado, N. Specchia, J. L. C. Van Susante, N. Verschoor, H. M. E. Quarles van Ufford, and F. C. Oner
- Subjects
Adult ,Male ,medicine.medical_specialty ,Bone Morphogenetic Protein 7 ,medicine.medical_treatment ,Pilot Projects ,Bone morphogenetic protein ,Transplantation, Autologous ,Iliac crest ,Ilium ,medicine ,Performed Procedure ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Adverse effect ,Aged ,Hematoma ,Bone Transplantation ,Lumbar Vertebrae ,business.industry ,Laminectomy ,Middle Aged ,Surgery ,Oswestry Disability Index ,Bone morphogenetic protein 7 ,Spinal Fusion ,Treatment Outcome ,medicine.anatomical_structure ,Spinal fusion ,Feasibility Studies ,Female ,Neurology (clinical) ,Spondylolisthesis ,business ,Follow-Up Studies - Abstract
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. more...
- Published
- 2010
- Full Text
- View/download PDF