Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a β-TCP-Collagen Matrix

Daniels, Timothy R.; Younger, Alastair; Penner, Murray; Wing, Kevin; Le, Ian; Russell, Iain; Lalonde, Karl-André; Evangelista, Peter; Quiton, Jovelyn D; Glazebrook, Mark; DiGiovanni, Christopher W.

doi:10.1177/1071100715576370

Cited by 51 publications

(46 citation statements)

References 20 publications

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“…From a clinical perspective, the FDA has approved the combination of PDGF-BB and β-tricalcium phosphate (TCP) for the treatment of periodontal defects (GEM21S®) [ 11 ]. Moreover, locally administered PDGF-BB and TCP (Augment®) have been investigated in acute wrist fractures [ 12 ] and proved to support hindfoot and ankle fusions [ 13 ]. Thus, supplementation of TCP with PDGF-BB is a favorable strategy in regenerative dentistry, orthopedics and traumatology.…”

Section: Introductionmentioning

confidence: 99%

Effect of recombinant PDGF-BB on bone formation in the presence of β-tricalcium phosphate and bovine bone mineral matrix: a pilot study in rat calvarial defects

et al. 2016

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BackgroundSupplementation of bone substitutes with recombinant platelet-derived growth factor-BB (PDGF-BB) can enhance bone regeneration. The aim of the study was to evaluate the effect of PDGF-BB on bone formation in the presence of β-tricalcium phosphate and bovine bone mineral matrix in a rat calvaria defect model.MethodsThe authors examined 5 mm rat calvarial defects treated with β-tricalcium phosphate (TCP) or demineralized bovine bone mineral (DBBM) with and without 0.3 mg/ml recombinant PDGF-BB. Calvaria defects were randomly divided into the following treatment groups (n = 5); TCP; TCP plus PDGF-BB; DBBM; DBBM plus PDGF-BB; and untreated empty control. After 45 days, bone formation was evaluated by histomorphometry and fluorescence microscopy.ResultsThe authors report that the area of newly formed bone was similar between the empty controls and the two bone substitutes, TCP and DBBM. Supplementation of TCP and DBBM with PDGF-BB had no significant impact on bone formation. Fluorochrome staining revealed no visible changes in the pattern of bone formation in defects filled with TCP and DBBM, irrespective of PDGF-BB. Furthermore, supplementation with PDGF-BB did not influence biomaterial degradation.ConclusionsThe authors concluded that PDGF-BB had no impact on bone formation and degradation of bone substitutes in the respective rodent models. Thus, possible beneficial effects of PDGF-BB may require other model situations.

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Section: Introductionmentioning

confidence: 99%

Effect of recombinant PDGF-BB on bone formation in the presence of β-tricalcium phosphate and bovine bone mineral matrix: a pilot study in rat calvarial defects

et al. 2016

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“…Recent attempts to improve union rates have included the use of growth factors at the fusion site. In a randomized controlled trial, Daniels et al evaluated the efficacy and safety of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) combined with an injectable, osteoconductive beta-tricalcium phosphate (b-TCP)-collagen matrix versus autograft (control) in ankle and hindfoot arthrodesis 39 . Complete fusion of all involved joints at 24 weeks was achieved in 84% of the patients treated with rhPDGF-BB and b-TCP-collagen matrix and in 65% of the patients treated with autograft (p < 0.001).…”

Section: Orthobiologics (Growth Factors)mentioning

confidence: 99%

What’s New in Foot and Ankle Surgery

Yeranosian

2016

The Journal of Bone and Joint Surgery

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“…This study also assessed clinical outcomes based on visual analog scale (VAS) score and lack of need for any secondary procedure after 1 year and demonstrated 91% of patients with PDGF fusions achieving clinical success compared to 78% of those treated with autograft. 14 In another prospective randomized controlled trial (RCT) from the North American Orthopedic Foot and Ankle Study Group, 434 patients were randomized (2:1) to rhPDGF or autograft-augmented fusion of the ankle or hindfoot. In the cohort that received rhPDGF, the fusion rate, as determined by CT scan at 6 months, was 62.0% (159/260 patients).…”

Section: Demineralized Bone Matrixmentioning

confidence: 99%

The Use of Bone Grafts, Bone Graft Substitutes, and Orthobiologics for Osseous Healing in Foot and Ankle Surgery

Peterson

Chen

Nwankwo

et al. 2019

Foot & Ankle Orthopaedics

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Achieving fusion in osseous procedures about the foot and ankle presents unique challenges to the surgeon. Many patients have comorbidities that reduce osseous healing rates, and the limited space and high weightbearing demand placed on fusion sites makes the choice of bone graft, bone graft substitute, or orthobiologic agent of utmost importance. In this review, we discuss the essential characteristics of grafts, including their osteoconductive, osteoinductive, osteogenic, and angiogenic properties. Autologous bone graft remains the gold standard and contains all these properties. However, the convenience and lack of donor site morbidity of synthetic bone grafts, allografts, and orthobiologics, including growth factors and allogenic stem cells, has led to these being used commonly as augments. Level of Evidence: Level V, expert opinion.

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Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a β-TCP-Collagen Matrix

Abstract: Level I, prospective randomized study.

Cited by 51 publications

References 20 publications

Effect of recombinant PDGF-BB on bone formation in the presence of β-tricalcium phosphate and bovine bone mineral matrix: a pilot study in rat calvarial defects

Effect of recombinant PDGF-BB on bone formation in the presence of β-tricalcium phosphate and bovine bone mineral matrix: a pilot study in rat calvarial defects

What’s New in Foot and Ankle Surgery

The Use of Bone Grafts, Bone Graft Substitutes, and Orthobiologics for Osseous Healing in Foot and Ankle Surgery

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