Recombinant Human Platelet-Derived Growth Factor-BB and Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP): An Alternative to Autogenous Bone Graft

2013 ◽  
Vol 95 (13) ◽  
pp. 1184-1192 ◽  
Author(s):  
Christopher W DiGiovanni ◽  
Sheldon S Lin ◽  
Judith F Baumhauer ◽  
Timothy Daniels ◽  
Alastair Younger ◽  
...  
Keyword(s):  
Growth Factor ◽  
Bone Graft ◽  
Tricalcium Phosphate ◽  
Human Platelet ◽  
Platelet Derived Growth Factor ◽  
Autogenous Bone Graft ◽  
Autogenous Bone ◽  
Beta Tricalcium Phosphate

Beta-tricalcium phosphate for orthopedic reconstructions as an alternative to autogenous bone graft

Morphologie ◽  
2017 ◽  
Vol 101 (334) ◽  
pp. 173-179 ◽  
Author(s):  
P. Hernigou ◽  
A. Dubory ◽  
J. Pariat ◽  
D. Potage ◽  
F. Roubineau ◽  
...  
Keyword(s):  
Bone Graft ◽  
Tricalcium Phosphate ◽  
Autogenous Bone Graft ◽  
Autogenous Bone ◽  
Beta Tricalcium Phosphate

Recombinant Human Platelet–Derived Growth Factor BB in Combination With a Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP)-Collagen Matrix as an Alternative to Autograft

2019 ◽  
Vol 40 (9) ◽  
pp. 1068-1078 ◽  
Author(s):  
Timothy R. Daniels ◽  
John Anderson ◽  
Michael P. Swords ◽  
Greg Maislin ◽  
Rafe Donahue ◽  
...  
Keyword(s):  
Growth Factor ◽  
Tricalcium Phosphate ◽  
Statistical Power ◽  
Human Platelet ◽  
Short Form ◽  
Surgical Techniques ◽  
Platelet Derived Growth Factor ◽  
Beta Tricalcium Phosphate ◽  
Graft Harvest ◽  
Clinical Healing

Background:Joint arthrodesis often employs autograft to promote union; graft harvesting can lead to perioperative morbidity. A Canadian randomized controlled trial (RCT) demonstrated that recombinant human platelet–derived growth factor BB homodimer (rhPDGF-BB) combined with beta-tricalcium phosphate (β-TCP)-collagen was a safe, effective alternative to autograft. This multicenter North American RCT compared the safety and efficacy of rhPDGF-BB/β-TCP-collagen with autograft for ankle and hindfoot fusion. Subclassification using propensity scores (PS) incorporated patients from previous trials for enhanced statistical power for noninferiority testing and broader review of treatments.Methods:Patients requiring ankle or hindfoot arthrodesis and supplemental bone graft were treated with rhPDGF-BB/β-TCP-collagen ( n = 69) or autograft ( n = 35). Outcomes included joint fusion on computed tomography (24 weeks), clinical healing status, visual analog scale (VAS) pain, Short-Form 12 (SF-12), American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale, and Foot Function Index (FFI) scores over 52 weeks. PS methodology addressed potential selection bias arising from pooling data among these patients and 2 previous RCTs with similar inclusion criteria, surgical techniques, graft harvest techniques, and outcomes. All 132 rhPDGF-BB/β-TCP-collagen–treated patients and 167 of 189 candidate autograft-treated controls were selected for comparison by an independent statistician blinded to outcomes.Results:In the PS subclassification, 68.1% treatment patients and 68.4% controls achieved >50% osseous bridging at fusion sites. Clinical healing status was achieved in 84.8% of treated patients and 90.7% of controls at 52 weeks. Clinical, functional, and quality of life results demonstrated noninferiority of rhPDGF-BB/β-TCP-collagen to autograft. Safety-related outcomes were equivalent.Conclusion:PS subclassification analysis of 3 RCTs demonstrated that rhPDGF-BB/β-TCP-collagen was as effective as autograft for ankle and hindfoot fusions, with less pain and morbidity than treatment with autograft.Level of Evidence:Level I, prospective randomized study.

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