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A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE® Bone Graft)

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Abstract

The combination of recombinant human bone morphogenetic protein-2 (rhBMP-2) on an absorbable collagen sponge (ACS) carrier has been shown to induce bone formation in a number of preclinical and clinical investigations. In 2002, rhBMP-2/ACS at a 1.5-mg/cc concentration (INFUSE® Bone Graft, Medtronic Spinal and Biologics, Memphis, TN) was FDA-approved as an autograft replacement for certain interbody spinal fusion procedures. In 2004, INFUSE® Bone Graft was approved for open tibial fractures with an intermedullary (IM) nail fixation. Most recently, in March 2007, INFUSE® Bone Graft was approved as an alternative to autogenous bone grafts for sinus augmentations, and for localised alveolar ridge augmentations for defects associated with extraction sockets. The culmination of extensive preclinical and clinical research and three FDA approvals makes rhBMP-2 one of the most studied, published and significant advances in orthopaedics. This review article summarises a number of clinical findings of rhBMP-2/ACS, including the FDA-approved investigational device exemption (IDE) studies used in gaining the aforementioned approvals.

Résumé

L’utilisation de la BMP (rhBPM-2) sur une éponge de collagène a des effets positifs sur l’ostéogénèse. En 2002, ce produit avec un dosage de 1.5 mg/cc (INFUSE® Bone Graft, Medtronic Spinal and Biologics, Memphis, Tenn), a été approuvé par la FDA comme un supplétif de l’auto greffe pour, certains cas d’arthrodèses rachidiennes. En 2004 ce produit (INFUSE®) a également été approuvé par la FDA pour les fractures ouvertes de jambes, traitées par clous centro-médullaires. De façon plus récente, en mars 2007, ce produit a été également autorisé comme une alternative au traitement des ostéolyses et défects osseux associés à l’ablation d’une cupule cotyloïdienne. L’association de ces autorisations et des recherches cliniques et pré-cliniques sur la rhBMP-2 permettent une avance significative des connaissances en chirurgie orthopédique ainsi que la revue des différents travaux et des autorisations de la FDA.

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Authors and Affiliations

  1. Medtronic Spinal and Biologics, 1800 Pyramid Place, Memphis, TN, 38132, USA

    William F. McKay, Steven M. Peckham & Jeffrey M. Badura

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  1. William F. McKay
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  2. Steven M. Peckham
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  3. Jeffrey M. Badura
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Correspondence to William F. McKay.

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McKay, W.F., Peckham, S.M. & Badura, J.M. A comprehensive clinical review of recombinant human bone morphogenetic protein-2 (INFUSE® Bone Graft). International Orthopaedics (SICO 31, 729–734 (2007). https://doi.org/10.1007/s00264-007-0418-6

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