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A prospective, randomized, controlled, multicenter study of osteogenic protein-1 in instrumented posterolateral fusions: report on safety and feasibility.

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.

journal_name

Spine (Phila Pa 1976)

journal_title

Spine

authors

Delawi D,Dhert WJ,Rillardon L,Gay E,Prestamburgo D,Garcia-Fernandez C,Guerado E,Specchia N,Van Susante JL,Verschoor N,van Ufford HM,Oner FC

doi

10.1097/BRS.0b013e3181d3cf28

subject

Has Abstract

pub_date

2010-05-20 00:00:00

pages

1185-91

issue

eissn

0362-2436

issn

1528-1159

journal_volume

pub_type

杂志文章,多中心研究,随机对照试验

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A prospective, randomized, controlled, multicenter study of osteogenic protein-1 in instrumented posterolateral fusions: report on safety and feasibility.