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- Title
Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data.
- Authors
Simmonds, Mark C; Brown, Jennifer V E; Heirs, Morag K; Higgins, Julian P T; Mannion, Richard J; Rodgers, Mark A; Stewart, Lesley A
- Abstract
<bold>Background: </bold>Recombinant human bone morphogenetic protein-2 (rhBMP-2) is widely used to promote fusion in spinal surgery, but its safety has been questioned.<bold>Purpose: </bold>To evaluate the effectiveness and safety of rhBMP-2.<bold>Data Sources: </bold>Individual-participant data obtained from the sponsor or investigators and data extracted from study publications identified by systematic bibliographic searches through June 2012.<bold>Study Selection: </bold>Randomized, controlled trials of rhBMP-2 versus iliac crest bone graft (ICBG) in spinal fusion surgery for degenerative disc disease and related conditions and observational studies in similar populations for investigation of adverse events.<bold>Data Extraction: </bold>Individual-participant data from 11 eligible of 17 provided trials sponsored by Medtronic (Minneapolis, Minnesota) (n = 1302) and 1 of 2 other eligible trials (n = 106) were included. Additional aggregate adverse event data were extracted from 35 published observational studies.<bold>Data Synthesis: </bold>Primary outcomes were pain (assessed with the Oswestry Disability Index [ODI] or Short Form-36), fusion, and adverse events. At 24 months, ODI scores were 3.5% lower (better) with rhBMP-2 than with ICBG (95% CI, 0.5% to 6.5%) and radiographic fusion was 12% higher (CI, 2% to 23%). At or shortly after surgery, pain was more common with rhBMP-2 (odds ratio, 1.78 [CI, 1.06 to 2.95]). Cancer was more common after rhBMP-2 (relative risk, 1.98 [CI, 0.86 to 4.54]), but the small number of events precluded definite conclusions.<bold>Limitation: </bold>The observational studies were diverse and at risk of bias.<bold>Conclusion: </bold>At 24 months, rhBMP-2 increases fusion rates, reduces pain by a clinically insignificant amount, and increases early postsurgical pain compared with ICBG. Evidence of increased cancer incidence is inconclusive.<bold>Primary Funding Source: </bold>Yale University Open Data Access Project.
- Publication
Annals of Internal Medicine, 2013, Vol 158, Issue 12, p877
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-158-12-201306180-00005