Prospective Clinical Pilot Trial in a Single Cohort Group of rhPDGF in Foot Arthrodeses

Daniels, Timothy R.; DiGiovanni, Christopher W.; Lau, Johnny; Wing, Kevin; Younger, Alastair

doi:10.3113/fai.2010.0473

Cited by 48 publications

(43 citation statements)

References 16 publications

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“…It is also noteworthy that the B2A-granule group in the current pilot study had a higher rate of complete union at 9 months 17 (greater than 67% bridging bone in the joint) compared to the autograft group (92% vs 75%), and compared to those rates cited in other studies (C. W. DiGiovanni et al, unpublished data, 2011). 7 This study showed a trend for autograft fusions to have less fusion mass compared to the B2A group, notably when the percentage fusion at 6 months was less than 67%. All of these observations suggest a more robust fusion with B2A-granule group, accepting that this study is underpowered to confirm this observation.…”

Section: Discussionmentioning

confidence: 91%

A Prospective Pilot Study of B2A-Coated Ceramic Granules (Amplex) Compared to Autograft for Ankle and Hindfoot Arthrodesis

Glazebrook

Younger²,

Wing³

et al. 2013

Foot Ankle Int.

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Section: Discussionmentioning

confidence: 91%

A Prospective Pilot Study of B2A-Coated Ceramic Granules (Amplex) Compared to Autograft for Ankle and Hindfoot Arthrodesis

Glazebrook

Younger²,

Wing³

et al. 2013

Foot Ankle Int.

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“…39 The authors concluded that this product was safe and it may be pursued further as an ICBG alternative, although few studies exist showing its effect in the foot and ankle. 39 Conclusions Autologous, allogenic, and synthetic graft materials have been used in ankle and hindfoot arthrodesis with varying degrees of success. Nonunion continues to be the most common reason for failure of foot and ankle fusion.…”

Section: Platelet-derived Growth Factormentioning

confidence: 97%

“…39 None of these patients had adverse events, and at 12 to 16 weeks, 44 of 59 (75%) patients showed moderate or complete osseous bridging. 39 The authors concluded that this product was safe and it may be pursued further as an ICBG alternative, although few studies exist showing its effect in the foot and ankle. 39 Conclusions Autologous, allogenic, and synthetic graft materials have been used in ankle and hindfoot arthrodesis with varying degrees of success.…”

Section: Platelet-derived Growth Factormentioning

confidence: 97%

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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“…This may be due to the logistics of applying these new techniques in the clinical setting, but also as they have not conclusively demonstrated clinical superiority over autologous bone grafts (18,29,30). …”

Section: Introductionmentioning

confidence: 99%

Tissue engineered vascularized periosteal flap enriched with MSC/EPCs for the treatment of large bone defects in rats

Nau

Henrich

Seebach

et al. 2017

International Journal of Molecular Medicine

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Vascularized periosteal flaps are used for complex cases if the reconstruction of large bone defects is necessary in modern trauma and orthopedic surgery. In this study, we combined this surgical procedure with β-TCP scaffold and mesenchymal stem cells (MSCs) + endothelial progenitor cells (EPCs) as a tissue engineering approach to obtain optimum conditions for bone healing in rats. A critical size femoral defect was created in 80 rats allocated into 4 groups. Defects were treated according to the following protocol: i) vascularized periosteal flap alone; ii) vascularized periosteal flap + β-TCP scaffold; iii) vascularized periosteal flap + β-TCP scaffold + ligated vascular pedicle; and ii) vascularized periosteal flap + β-TCP scaffold + MSCs/EPCs. After 8 weeks, femur bones were extracted and analyzed for new bone formation, vascularization, proliferation and inflammatory processes and strength. Bone mineral density (BMD) and biomechanical stability at week 8 were highest in group 4 (flap + β-TCP scaffold + MSCs/EPCs) compared to all the other groups. Stability was significantly higher in group 4 (flap + β-TCP scaffold + MSCs/EPCs) in comparison to group 3 (ligated flap + β-TCP scaffold). BMD was found to be significantly lower in group 3 (ligated flap + β-TCP scaffold) compared to group 1 (flap) and group 4 (flap + β-TCP scaffold + MSCs/EPCs). The highest density of blood vessels was observed in group 4 (flap + β-TCP + MSCs/EPCs) and the values were significantly increased in comparison to group 3 (ligated flap), but not to group 1 (flap) and group 2 (flap + β-TCP). The highest amounts of proliferating cells were observed in group 4 (flap + β-TCP scaffold + MSC/EPCs). The percentage of proliferating cells was significantly higher in group 4 (flap + β-TCP scaffold + MSCs/EPCs) in comparison to all the other groups after 8 weeks. Our data thus indicate that critical size defect healing could be improved if MSCs/EPCs are added to β-TCP scaffold in combination with a periosteal flap. Even after 8 weeks, the amount of proliferating cells was increased. The flap blood supply is essential for bone healing and the reduction of inflammatory processes.

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Prospective Clinical Pilot Trial in a Single Cohort Group of rhPDGF in Foot Arthrodeses

Abstract: 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.

Cited by 48 publications

References 16 publications

A Prospective Pilot Study of B2A-Coated Ceramic Granules (Amplex) Compared to Autograft for Ankle and Hindfoot Arthrodesis

A Prospective Pilot Study of B2A-Coated Ceramic Granules (Amplex) Compared to Autograft for Ankle and Hindfoot Arthrodesis

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

Tissue engineered vascularized periosteal flap enriched with MSC/EPCs for the treatment of large bone defects in rats

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