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 Fracture
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 Fracture
The primary objective of this study is to assess whether a single dose of rhBMP-2/CPM administered at the fracture site via percutaneous injection, in combination with standard of care, accelerates fracture union and return to normal function in subjects who have a closed diaphyseal tibial fracture when compared to standard of care alone.
Inclusion Criteria:
Exclusion Criteria:
Cerequeira Cesar, São Paulo 05403-010, Brazil
Vila Clemetino, São Paulo 04020-060, Brazil
Hyderabad, Andhra Pradesh 500063, India
Col. Los Morales, Del Miguel, Hidalgo 11520, Mexico
Col. El Retiro, Guadalajara, Jal. 44280, Mexico
Guadalajara, Jal, CP45235,, Mexico