Abstract
To demonstrate the potential clinical benefits and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2)/Absorbable Collagen Sponge (ACS) in the treatment of open tibial shaft fractures, as measured by the reduction of secondary interventions to promote fracture healing. In this prospective, controlled, multinational trial, patients were randomized to standard care (intramedullary nail and soft tissue management) or to standard care and rhBMP-2/ACS (0. 75mg/ml, 1. 5 mg/ml) implanted at definitive wound closure. 450 patients were enrolled at 49 centres. RhBMP-2 dose-dependently decreased the risk of secondary intervention for delayed union (p=0. 0004). Safety was similar among treatment groups.
The abstracts were prepared by Mr Simon Donell. Correspondence should be addressed to him at the Department of Orthopaedics, Norfolk & Norwich Hospital, Level 4, Centre Block, Colney Lane, Norwich NR4 7UY, United Kingdom
