Objectives: To compare radiographic union of tibia fractures with bone defects treated with recombinant bone morphogenetic protein-2 (rhBMP-2) with allograft to autogenous iliac crest bone graft (ICBG).
Design: FDA-regulated multicenter randomized trial.
Setting: Sixteen US trauma centers.
Patients/participants: Thirty patients (18-65 years of age) with Type II, IIIA, or IIIB open tibia fracture and bone defect treated with an intramedullary nail.
Intervention: rhBMP-2 (n = 16) versus ICBG (n = 14).
Main outcome measurements: Radiographic union within 52 weeks. Secondary outcomes included clinical healing, patient-reported function, major complications, and treatment cost. Equivalence was evaluated by testing whether a 90% two-sided confidence interval for the difference in the probability of radiographic union between rhBMP-2 or ICBG is contained with the interval [220% to +20%]. A post hoc Bayesian analysis, using data from a previous trial, was also conducted.
Results: Twenty-three patients had union data at 52 weeks: 7/12 (58.3%) rhBMP-2 were radiographically united compared with 9/11 (81.8%) ICBG, resulting in a treatment difference of -0.23 (90% CI: -0.55 to 0.10). Patients treated with rhBMP-2 had lower rates of clinical healing at 52 weeks (27% vs. 54%), higher mean Short Musculoskeletal Function Assessment scores (dysfunction: 33.3 vs. 23.7; bother score: 32.8 vs. 21.4) and experienced more complications (5 vs. 3). Mean treatment cost for rhBMP-2 was estimated at $14,155 versus $9086 for ICBG.
Conclusions: These data do not provide sufficient evidence to conclude that ICBG and rhBMP-2 are equivalent regarding radiographic union.
Level of evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
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Recombinant human BMP-2 and allograft compared with autogenous bone graft for reconstruction of diaphyseal tibial fractures with cortical defects. A randomized, controlled trial.J Bone Joint Surg Am. 2006 Jul;88(7):1431-41. doi: 10.2106/JBJS.E.00381. J Bone Joint Surg Am. 2006. PMID: 16818967 Clinical Trial.
Clinical effectiveness and cost-effectiveness of bone morphogenetic proteins in the non-healing of fractures and spinal fusion: a systematic review.Health Technol Assess. 2007 Aug;11(30):1-150, iii-iv. doi: 10.3310/hta11300. Health Technol Assess. 2007. PMID: 17669279 Review.
Recombinant human BMP-2 for the treatment of open tibial fractures.Orthopedics. 2012 Jun;35(6):e847-54. doi: 10.3928/01477447-20120525-23. Orthopedics. 2012. PMID: 22691656 Review.