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Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant.

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Presentation on theme: "Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant."— Presentation transcript:

1 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Summary of evidence search and selection. ICBG = iliac crest bone graft; IPD = individual-patient data; RCT = randomized, controlled trial. * One additional RCT (19) was eligible, but IPD were not provided. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

2 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Meta-analyses of pain outcomes at 6 wk and 3, 6, 12, and 24 mo after surgery. Points on the plot represent mean differences in changes in scores (from preoperative values) at each time point, and vertical lines show the 95% CIs. For the first 3 outcomes, points below the dotted line indicate a benefit of rhBMP-2; for the SF-36 PCS score, points above the line indicate a benefit of rhBMP-2. ICBG = iliac crest bone graft; PCS = Physical Component Summary; rhBMP-2 = recombinant human bone morphogenetic protein-2; SF-36 = Short Form-36. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

3 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Reduction in pain scores from preoperative results, by treatment received. ICBG = iliac crest bone graft; PCS = Physical Component Summary; rhBMP-2 = recombinant human bone morphogenetic protein-2; SF-36 = Short Form-36. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

4 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Results of 1-stage meta-analyses of pain and function outcomes at 6 wk and 3, 6, 12, and 24 mo after surgery. ICBG = iliac crest bone graft; PCS = Physical Component Summary; rhBMP-2 = recombinant human bone morphogenetic protein-2; SF-36 = Short Form-36. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

5 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Forest plot of RR for successful fusion 24 mo after surgery. ALIF = anterior lumbar interbody fusion; BCP = biphasic calcium phosphate; ICBG = iliac crest bone graft; PLIF = posterior lumbar interbody fusion; rhBMP-2 = recombinant human bone morphogenetic protein-2; RR = relative risk. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

6 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Subgroup analyses for Oswestry Disability Index (top) and successful fusion (bottom), by surgical approach. ALIF = anterior lumbar interbody fusion; BCP = biphasic calcium phosphate; ICBG = iliac crest bone graft; MD = mean difference; PLIF = posterior lumbar interbody fusion; rhBMP-2 = recombinant human bone morphogenetic protein-2; RR = relative risk. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

7 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 MD in operating time (minutes) between rhBMP-2 and ICBG in the Medtronic trials. Details on the Medtronic trials are available in Appendix Table 1. ALIF = anterior lumbar interbody fusion; BCP = biphasic calcium phosphate; ICBG = iliac crest bone graft; MD = mean difference; PLIF = posterior lumbar interbody fusion; rhBMP-2 = recombinant human bone morphogenetic protein-2. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

8 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Meta-analysis of use of 4 types of pain medication in Medtronic trials. ICBG = iliac crest bone graft; rhBMP-2 = recombinant human bone morphogenetic protein-2. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

9 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Relationship between relative risk for fusion and mean difference in pain outcomes across trials 24 mo after surgery. PCS = Physical Component Summary; SF-36 = Short Form-36. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

10 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Meta-analysis of adverse events at or shortly after surgery in 11 Medtronic trials. Details on the Medtronic trials are available in Appendix Table 1. ICBG = iliac crest bone graft; OR = odds ratio; rhBMP-2 = recombinant human bone morphogenetic protein-2. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

11 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Meta-analysis of all adverse events in 11 Medtronic trials. Details on the Medtronic trials are available in Appendix Table 1. ICBG = iliac crest bone graft; OR = odds ratio; rhBMP-2 = recombinant human bone morphogenetic protein-2. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

12 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Meta-analyses of adverse events. ICBG = iliac crest bone graft; rhBMP-2 = recombinant human bone morphogenetic protein-2. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

13 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Forest plot of cancer incidence in the Medtronic trials. The number of cancer cases is the total number occurring during the 2-y follow-up. Details on the Medtronic trials are available in Appendix Table 1. BCP = biphasic calcium phosphate; ICBG = iliac crest bone graft; rhBMP-2 = recombinant human bone morphogenetic protein-2; RR = relative risk. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

14 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Heterotopic bone formation, radiculitis, and dysphagia in nonrandomized studies of rhBMP-2. ACDF = anterior cervical discectomy and fusion; ICBG = iliac crest bone graft; CSA = cervical spinal arthrodesis; LIF = lumbar interbody fusion; PCF = posterior cervical fusion; PLF = posterolateral lumbar fusion; PLIF = posterior lumbar interbody fusion; rhBMP-2 = recombinant human bone morphogenetic protein-2; RR = relative risk; SCP = silicated calcium phosphate; TLIF = transforaminal lumbar interbody fusion. Figure Legend: Copyright © American College of Physicians. All rights reserved.American College of Physicians

15 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Copyright © American College of Physicians. All rights reserved.American College of Physicians

16 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Copyright © American College of Physicians. All rights reserved.American College of Physicians

17 Date of download: 6/2/2016 From: Safety and Effectiveness of Recombinant Human Bone Morphogenetic Protein-2 for Spinal Fusion: A Meta-analysis of Individual-Participant Data Ann Intern Med. 2013;158(12):877-889. doi:10.7326/0003-4819-158-12-201306180-00005 Copyright © American College of Physicians. All rights reserved.American College of Physicians

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