BACKGROUND: Augment Bone Graft, a fully synthetic bone graft material composed of recombinant human PDGF and a calcium phosphate matrix (rhPDGF/TCP), has been considered as a possible alternative to autogenous bone graft. Before proceeding with randomized control studies comparing rhPDGF/TCP to autograft bone, a human trial to assess efficacy and safety was required. MATERIALS AND METHODS: The current study was a prospective, open-label, multi-center trial designed to evaluate rhPDGF in a calcium phosphate matrix (Augment Bone Graft). Sixty patients requiring hindfoot or midfoot fusion were prospectively followed for 36 weeks. All patients received 0.9 to 2.7 mg of rhPDGF at the fusion sites and returned for clinical and radiographic review at Day 7 to 14 and Weeks 6, 9, 12, 16, 24, and 36. Computerized tomography (CT) scans of the fusion site were obtained at the 6- and 12-week postoperative appointment, with an additional CT scan at 16 weeks if required. RESULTS: No patients suffered a serious adverse event caused by rhPDGF. CT scan evaluation at 12- to 16-week time periods revealed moderate or complete osseous bridging of 75% (44/59) at 36 weeks. CONCLUSION: These results indicate that rhPDGF is a safe product and provides clinical/radiographic outcomes that justify the pursuit of randomized controlled studies comparing rhPDGF/TCP to autograft.
RCT Entities:
BACKGROUND: Augment Bone Graft, a fully synthetic bone graft material composed of recombinant human PDGF and a calcium phosphate matrix (rhPDGF/TCP), has been considered as a possible alternative to autogenous bone graft. Before proceeding with randomized control studies comparing rhPDGF/TCP to autograft bone, a human trial to assess efficacy and safety was required. MATERIALS AND METHODS: The current study was a prospective, open-label, multi-center trial designed to evaluate rhPDGF in a calcium phosphate matrix (Augment Bone Graft). Sixty patients requiring hindfoot or midfoot fusion were prospectively followed for 36 weeks. All patients received 0.9 to 2.7 mg of rhPDGF at the fusion sites and returned for clinical and radiographic review at Day 7 to 14 and Weeks 6, 9, 12, 16, 24, and 36. Computerized tomography (CT) scans of the fusion site were obtained at the 6- and 12-week postoperative appointment, with an additional CT scan at 16 weeks if required. RESULTS: No patients suffered a serious adverse event caused by rhPDGF. CT scan evaluation at 12- to 16-week time periods revealed moderate or complete osseous bridging of 75% (44/59) at 36 weeks. CONCLUSION: These results indicate that rhPDGF is a safe product and provides clinical/radiographic outcomes that justify the pursuit of randomized controlled studies comparing rhPDGF/TCP to autograft.
Authors: Darnell Kaigler; Gustavo Avila; Leslie Wisner-Lynch; Marc L Nevins; Myron Nevins; Giulio Rasperini; Samuel E Lynch; William V Giannobile Journal: Expert Opin Biol Ther Date: 2011-02-03 Impact factor: 4.388
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Authors: Stephen H Cummings; Daniel A Grande; Christopher K Hee; Hans K Kestler; Colleen M Roden; Neil V Shah; Pasquale Razzano; David M Dines; Nadeen O Chahine; Joshua S Dines Journal: J Tissue Eng Date: 2012-07-02 Impact factor: 7.813