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Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the healing patterns associated with allograft interbody constructs in comparison with autograft. Spine 2006; 31:775-781. This is the second multicenter study comparing allograft threaded dowels combined with either autograft or rhBMP-2/ACS. A total of 131 patients were randomized into these two study groups and followed for 2 years with serial CT scans and an outcome battery. The investigational group showed significantly less blood loss, shorter surgical time, hospital stays and fusion rates and observed transient zones of remodeling all healed. Additionally, the investigational group exhibited significantly better SF-36, leg and back pain scores. The study demonstrates that threaded allograft dowels combined with rhBMP2/ACS eliminate graft site pain and offered significantly (P<0.001) higher fusion rates
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Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the healing patterns associated with allograft interbody constructs in comparison with autograft. Spine 2006; 31:775-781. This is the second multicenter study comparing allograft threaded dowels combined with either autograft or rhBMP-2/ACS. A total of 131 patients were randomized into these two study groups and followed for 2 years with serial CT scans and an outcome battery. The investigational group showed significantly less blood loss, shorter surgical time, hospital stays and fusion rates and observed transient zones of remodeling all healed. Additionally, the investigational group exhibited significantly better SF-36, leg and back pain scores. The study demonstrates that threaded allograft dowels combined with rhBMP2/ACS eliminate graft site pain and offered significantly (P<0.001) higher fusion rates.
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Pradhan BB, Bae HW, Dawson EG, et al. Graft resorption with the use of bone morphogenetic protein: lessons from anterior lumbar interbody fusion using femoral ring allografts and recombinant human bone morphogenetic protein-2. Spine 2006; 31:277-284. The authors report the prospective results of 36 patients treated with anterior interbody fusions combining stand-alone allograft femoral rings with rhBMP-2 or the control group of 27 individuals in whom autograft was combined with allograft femoral rings. Radiographic comparison of the two groups identified that 36, 10/27) of the autograft group failed to fuse compared with a much higher fusion failure of 56, five of nine in the rhBMP-2 group. The rhBMP-2 group's CT scans demonstrated aggressive graft resorption and fragmentation, resulting in nonunions causing the early termination of this study arm
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Pradhan BB, Bae HW, Dawson EG, et al. Graft resorption with the use of bone morphogenetic protein: lessons from anterior lumbar interbody fusion using femoral ring allografts and recombinant human bone morphogenetic protein-2. Spine 2006; 31:277-284. The authors report the prospective results of 36 patients treated with anterior interbody fusions combining stand-alone allograft femoral rings with rhBMP-2 or the control group of 27 individuals in whom autograft was combined with allograft femoral rings. Radiographic comparison of the two groups identified that 36% (10/27) of the autograft group failed to fuse compared with a much higher fusion failure of 56% (five of nine) in the rhBMP-2 group. The rhBMP-2 group's CT scans demonstrated aggressive graft resorption and fragmentation, resulting in nonunions causing the early termination of this study arm.
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Dimar JR, Glassman SD, Burkus JK, et al. A large-scale, level 1, clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine fusion. Paper presented at the 40th Annual Meeting of the North American Spine Society; Seattle, WA; 2006. The authors present the 2-year results of a randomized, prospective study of instrumented single-level posterolateral fusion comparing ICBG with a 40mg dose of rhBPM-2/CRM. Demographic data demonstrated significantly (P<0.001) less blood loss (343 versus 449cm3) and operative time (2.5 versus 2.9 h) in the investigational group. Plain radiographs demonstrated an 86.8% fusion rate in the ICBG group compared with an rhBMP-2 fusion rate of 94.9%, while CT scans showed fusion rates of 82.6 and 92.6%. Outcome measures demonstrated similar improvements over all time intervals. Sixty-four percent of the ICBG group still reported graft site pain 2 years later. The authors concluded that the rhBMP-2/CRM was an effective bone graft replacement.
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