OTA2018: Equivalence not demonstrated, higher union with ICBG vs. rhBMP-2 for open tibial fracture .
A Randomized Controlled Trial Comparing rhBMP-2 Versus Autograft for the Treatment of Tibia Fractures With Critical Size Defects
23 patients with an open midshaft tibial fracture fixed with an intramedullary nail were randomized to grafting using a recombinant human morphogenetic protein (rhBMP)-2 supplemented allograft or an autologous iliac crest bone graft (ICBG). Equivalence of rhBMP-2 to ICBG was tested for radiographic union rate, using an equivalence margin of -20% to +20%. Comparison of groups could not conclude equivalence of rhBMP-2 to ICBG, with union rates within 52 weeks of 58.3% and 81.8% in the groups, respectively.
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