A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP 2)/Calcium Phosphate Matrix (CPM) in Closed Diaphyseal Tibial Fractures

Update Il y a 5 ans
Reference: EUCTR2006-001831-23

Woman and Man

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Extract

1. To demonstrate a reduction of time to fracture union based on assessments of radiographs by a central evaluation committee (CEC). 2. To demonstrate acceleration of return to normal function based on the time to full weight bearing (FWB) without pain at the fracture site, as established by the investigator.


Inclusion criteria

  • Closed diaphyseal tibial fracture