STUDY DESIGN.: Meta-analysis of individual patient data from randomized controlled trials of recombinant human bone morphogenetic protein-2 (rhBMP-2) in lumbar spinal fusion. OBJECTIVE.: To determine how patient characteristics impact estimates of effectiveness and harms of rhBMP-2 versus iliac crest bone graft (ICBG) in lumbar spinal fusion. SUMMARY OF BACKGROUND DATA.: Patient characteristics are thought to impact rates of fusion in spinal fusion surgery, but no analyses examining the effect of patient characteristics on efficacy and safety of rhBMP-2 as compared to ICBG have been conducted. METHODS.: Using individual patient data obtained from the Yale Open Data Access (YODA) Project, the impact of patient characteristics on the effects of rhBMP-2 on fusion, overall success, and harms were assessed using linear and generalized linear mixed effects models. RESULTS.: Ten industry-sponsored randomized, controlled trials of rhBMP-2 were included in the analysis. There is preliminary support for an association between rhBMP-2 and improved outcomes for smokers (p?=?0.01), individuals under the age of 60 (p?
ASJC Scopus subject areas
- Clinical Neurology
- Orthopedics and Sports Medicine