Prospective, Randomized, Multi-Center Feasibility Trial of rhPDGF-BB versus Autologous Bone Graft in a Foot and Ankle Fusion Model

DiGiovanni, Christopher W.; Baumhauer, Judith F.; Lin, Sheldon S.; Berberian, Wayne S.; Flemister, Adolph S.; Enna, Matthew J.; Evangelista, Peter; Newman, June

doi:10.3113/fai.2011.0344

Cited by 67 publications

(62 citation statements)

References 25 publications

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“…38 The research group did, however, show a 14% nonunion rate (2/14). 38 Based on blinded CT scan analysis, healing rates (defined as 50% osseous bridging) were mildly different: 69% (9/13) of the treatment group showed healing, whereas 60% (3/5) in the ICBG group healed. 38 They reported no significant adverse effects related to this orthobiological combination.…”

Section: Platelet-derived Growth Factormentioning

confidence: 87%

“…38 This group also found that the use of ICBG added 26 minutes to the surgery on average compared to the rhPDF/TCP combination. 38 A study by Daniels et al 39 also evaluated a product consisting of recombinant human PDGF with a calcium phosphate matrix (TCP). This was a prospective multicenter study with 60 patients and primarily designed to test this compound's safety in hindfoot or midfoot fusion.…”

Section: Platelet-derived Growth Factormentioning

confidence: 93%

“…38 Based on blinded CT scan analysis, healing rates (defined as 50% osseous bridging) were mildly different: 69% (9/13) of the treatment group showed healing, whereas 60% (3/5) in the ICBG group healed. 38 They reported no significant adverse effects related to this orthobiological combination. 38 When testing if the patient made antibodies to rhPDGF, 15% (2/13) were found to have positive titers, one of which normalized after a few months, whereas the other trended toward baseline.…”

Section: Platelet-derived Growth Factormentioning

confidence: 99%

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A Historical Review of Common Bone Graft Materials in Foot and Ankle Surgery

Arner

Santrock

2014

Foot & Ankle Specialist

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Foot and ankle fusion is an important treatment for arthritis and deformities of the ankle and hindfoot. The literature has shown that there are improvements in fusion rates with the addition of bone graft and bone graft substitutes. Today autografts, specifically the iliac crest bone graft (ICBG), continue to be the gold standard despite significant donor site morbidity and nonunion rates, persisting around 10%. To address these drawbacks, bone graft substitutes have been developed. This article includes a historical review of the use, outcomes, and safety of autografts, allografts, and bone graft substitutes, such as ceramics, demineralized bone matrix, and platelet-derived growth factor.

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Section: Platelet-derived Growth Factormentioning

confidence: 87%

Section: Platelet-derived Growth Factormentioning

confidence: 93%

Section: Platelet-derived Growth Factormentioning

confidence: 99%

See 1 more Smart Citation

A Historical Review of Common Bone Graft Materials in Foot and Ankle Surgery

Arner

Santrock

2014

Foot & Ankle Specialist

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“…Among the PDGF isoforms, PDGF-BB is considered ‘universal’, mainly due to its ability to bind to both known forms of PDGF-receptor isotypes. In the musculoskeletal system, recombinant human PDGF-BB injection therapy has already been employed in experimental and clinical studies to promote fracture healing and foot and ankle fusion rates (27,28). It is considered important in upregulating cytokines that enhance osseous and soft-tissue healing and regeneration.…”

Section: Discussionmentioning

confidence: 99%

Molecular profile of major growth factors in lumbar intervertebral disc herniation: Correlation with patient clinical and epidemiological characteristics

Tsarouhas

Soufla

Tsarouhas

et al. 2017

Molecular Medicine Reports

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The involvement of growth factors (GFs) in the pathogenesis of lumbar intervertebral disc (ID) herniation and the spontaneous resorption of herniated ID fragments remains only partially elucidated. A simultaneous assessment of the transcript levels of numerous GFs and their association with clinical and epidemiological profiles of human ID herniation would provide valuable insight into the biology and clinical course of the disease. In the present study, we examined simultaneously the transcript levels of vascular endothelial growth factor (VEGF), transforming growth factor β1 (TGF-β1), basic fibroblast growth factor 2 (bFGF2), platelet derived growth factor (PDGF) isoforms and receptors, epidermal growth factor (EGF) and insulin growth factor-1 (IGF-1) in herniated and control ID specimens and investigated their correlation with the clinicopathological profiles of patients suffering from symptomatic lumbar ID herniation. GF mRNA expression levels were determined by RT-qPCR in 63 surgical specimens from lumbar herniated discs and 10 control ID specimens. Multiple positive correlations were observed between the transcript levels of the GFs examined in the ID herniation group. VEGF mRNA expression was significantly increased in the protruding compared with the extruded discs. Intense and acute pain significantly upregulated the PDGF transcript levels. Significant negative correlations were observed between the patient body mass index and the transcript levels of VEGF and PDGF receptors. Our findings support the hypothesis of the involvement of GFs in the natural history of ID herniation. GFs synergistically act in herniated IDs. Increased VEGF expression possibly induces the neovascularization process in the earliest stages of ID herniation. PDGF-C and -D play a role in the acute phase of radiculopathy in a metabolic response for tissue healing. A molecular effect, in addition to the biomechanical effect of obesity in the pathogenesis of ID herniation is also implied.

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“…A related rPDGF/β-TCP product, AUGMENT® (BioMimetic Therapeutics) has been evaluated as a healing adjunct in foot and ankle surgeries and distal radius fractures. A randomized, controlled pilot study suggested that AUGMENT® was at least as effective as autologous bone graft in stimulating hindfoot and ankle fusion [182]. …”

Section: Gfs Commonly Used For Bone Tissue Engineering Applicationsmentioning

confidence: 99%

Taking cues from the extracellular matrix to design bone-mimetic regenerative scaffolds

et al. 2016

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There is an ongoing need for effective materials that can replace autologous bone grafts in the clinical treatment of bone injuries and deficiencies. In recent years, research efforts have shifted away from a focus on inert biomaterials to favor scaffolds that mimic the biochemistry and structure of the native bone extracellular matrix (ECM). The expectation is that such scaffolds will integrate with host tissue and actively promote osseous healing. To further enhance the osteoinductivity of bone graft substitutes, ECM-mimetic scaffolds are being engineered with a range of growth factors (GFs). The technologies used to generate GF-modified scaffolds are often inspired by natural processes that regulate the association between endogenous ECMs and GFs. The purpose of this review is to summarize research centered on the development of regenerative scaffolds that replicate the fundamental collagen-hydroxyapatite structure of native bone ECM, and the functionalization of these scaffolds with GFs that stimulate critical events in osteogenesis.

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Prospective, Randomized, Multi-Center Feasibility Trial of rhPDGF-BB versus Autologous Bone Graft in a Foot and Ankle Fusion Model

Abstract: Based on the available data, the rate of radiographic union, time to full weightbearing, and outcomes scores between the Augment™ and ABG subjects appear comparable. Augment™ may represent a safe and efficacious treatment alternative to ABG during foot and ankle arthrodesis.

Cited by 67 publications

References 25 publications

A Historical Review of Common Bone Graft Materials in Foot and Ankle Surgery

A Historical Review of Common Bone Graft Materials in Foot and Ankle Surgery

Molecular profile of major growth factors in lumbar intervertebral disc herniation: Correlation with patient clinical and epidemiological characteristics

Taking cues from the extracellular matrix to design bone-mimetic regenerative scaffolds

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