Compression of ACS limited the amount of bone induction observed within the defect.īRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR: Biomechanical strength of limbs treated with rhBMP-2 was greater than or equal to autograft-treated defects. No deleterious effects on radiocarpal joint observed when rhBMP-2/ACS placed in a distal radius defect connected to joint cavity.Ĭanine femoral allograft incorporation n=21Īugmentation of the allograft-host bone junctions with rhBMP-2/ACS resulted in a stronger and more complete union than with autograft.ĭefects treated with rhBMP-2/ACS healed at 12 weeks. rhBMP-2/ACS had radiopaque bridging by 8 weeks. Histology demonstrated bone formation with abundant normal-appearing osteoid.Ĭontrol groups had significantly less new bone than rhBMP-2/ACS. High dose rhBMP-2/ACS healed 100% of the defects. No defects implanted with only the ACS achieved union. RhBMP-2 dose-response-related healing of critical-sized defects measured by radiographic and histologic criteria. From these studies the 1.50 mg/ml rhBMP-2/ACS concentration (Infuse Bone Graft) was found to be clinically effective. This is measured as quantity of rhBMP-2 per unit volume of ACS.īoth the concentration of rhBMP-2 and the length of time that rhBMP-2 is present at the implant site are positively correlated with the rate of bone formation, the amount of bone formed, and the density of the resulting bone. Three dose-ranging clinical studies have been conducted to identify the effective therapeutic concentration of rhBMP-2/ACS for tibial fractures.
HUMAN CLINICAL TRIALS DETERMINE EFFECTIVE CONCENTRATION OF rhBMP-2 The studies determined the effective dose of rhBMP-2 to be applied to the absorbable collagen sponge (ACS), its success rate in reducing the number of fracture nonunions, and it's healing effect on surrounding soft tissues. Human clinical studies of Infuse Bone Graft have evaluated the effectiveness of recombinant human bone morphogenetic protein-2 (rhBMP-2) in healing open tibial fractures.
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