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CLINICAL BENEFITS OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 IN THE TREATMENT OF OPEN TIBIAL SHAFT FRACTURES
0
Zitationen
3
Autoren
2003
Jahr
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.
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