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Scientific Articles   |    
Recombinant Human Platelet-Derived Growth Factor-BB and Beta-Tricalcium Phosphate (rhPDGF-BB/β-TCP): An Alternative to Autogenous Bone Graft
Christopher W. DiGiovanni, MD1; Sheldon S. Lin, MD2; Judith F. Baumhauer, MD, MPH3; Timothy Daniels, MD4; Alastair Younger, MD5; Mark Glazebrook, MD, PhD6; John Anderson, MD7; Robert Anderson, MD8; Peter Evangelista, MD1; Samuel E. Lynch, DMD, DMSc9; the North American Orthopedic Foot and Ankle Study Group
1 Department of Orthopaedic Surgery (C.W.D.) and the Department of Diagnostic Imaging (P.E.), The Warren Alpert School of Medicine at Brown University, Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903. E-mail address for C.W. DiGiovanni: christopher_digiovanni@brown.edu
2 University of Medicine & Dentistry of New Jersey, 90 Bergen Street, Suite #7300, Newark, NJ 07101
3 University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642
4 St. Michael’s Hospital, 55 Queen Street East, Suite 800, Toronto, ON M5C 1R6, Canada
5 St. Paul’s Hospital, Burrard Medical Centre, 1144 Burrard Street, Suite 560, Vancouver, BC V6Z 2A5, Canada
6 Halifax Infirmary, 1796 Summer Street, Room 4867, Halifax, NS B3H 3A7, Canada
7 Orthopaedic Associates of Michigan, PC, 1111 Leffingwell N.E., Suite 100, Grand Rapids, MI 49525
8 OrthoCarolina Research Institute, Inc., 2001 Vail Avenue, Suite 250, Charlotte, NC 28207
9 BioMimetic Therapeutics, Inc., 389 Nichol Mill Lane, Franklin, TN 37067
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  • Disclosure statement for author(s): PDF

The following North American Orthopedic Foot and Ankle Study Group investigators participated in this study: Nicholas A. Abidi, MD, Jorge I. Acevedo, MD, Wayne Berberian, MD, Gregory C. Berlet, MD, Christopher Bibbo, DO, Donald Bohay, MD, Bradley J. Brainard, MD, Bruce Cohen, MD, W. Hodges Davis, MD, Keith Donatto, MD, Hugh Dougall, MD, Mark E. Easley, MD, Andrew A. Elliott, MD, Adolph Samuel Flemister Jr., MD, William Granberry, MD, Justin Greisberg, MD, Steven L. Haddad, MD, Anthony Hinz, MD, Susan N. Ishikawa, MD, Juha I. Jaakkola, MD, Johnny Lau, MD, Ian Le, MD, Thomas Lee, MD, John Maskill, MD, G. Andrew Murphy, MD, Steven K. Neufeld, MD, M.J. O’Malley, MD, Murray Penner, MD, Terrence Philbin, DO, Michael Pinzur, MD, Steven Raikin, MD, Iain Russell, MD, Lew Schon, MD, James J. Sferra, MD, Naomi Shields, MD, Nebojsa Skrepnik, MD, Raymond Sullivan, MD, Michael Swords, DO, A. Brian Thomson, MD, Troy Watson, MD, and Kevin Wing, MD.

Investigation performed at thirty-seven clinical sites in North America

A commentary by Zbigniew Gugala, MD, PhD, is linked to the online version of this article at jbjs.org.



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2013 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2013 Jul 03;95(13):1184-1192. doi: 10.2106/JBJS.K.01422
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Abstract

Background: 

Joint arthrodesis employing autogenous bone graft (autograft) remains a mainstay in the treatment of many foot and ankle problems. However, graft harvest can lead to perioperative morbidity and increased cost. We tested the hypothesis that purified recombinant human platelet-derived growth factor-BB (rhPDGF-BB) homodimer combined with an osteoconductive matrix (beta-tricalcium phosphate [β-TCP]) would be a safe and effective alternative to autograft.

Methods: 

A total of 434 patients were enrolled in thirty-seven clinical sites across North America in a prospective, randomized (2:1), controlled, non-inferiority clinical trial to compare the safety and efficacy of the combination rhPDGF-BB and β-TCP with those of autograft in patients requiring hindfoot or ankle arthrodesis. Radiographic, clinical, functional, and quality-of-life end points were assessed through fifty-two weeks postoperatively.

Results: 

Two hundred and sixty patients (394 joints) underwent arthrodesis with use of rhPDGF-BB/β-TCP. One hundred and thirty-seven patients (203 joints) underwent arthrodesis with use of autograft. With regard to the primary end point, 159 patients (61.2% [262 joints (66.5%)]) in the rhPDGF-BB/β-TCP group and eighty-five patients (62.0% [127 joints (62.6%)]) in the autograft group were fused as determined by computed tomography at six months (p < 0.05). Clinically, 224 patients (86.2%) [348 joints (88.3%)]) in the rhPDGF-BB/β-TCP group were considered healed at fifty-two weeks, compared with 120 patients (87.6% [177 joints (87.2%)] in the autograft group (p = 0.008). Overall, fourteen of sixteen secondary end points at twenty-four weeks and fifteen of sixteen secondary end points at fifty-two weeks demonstrated statistical non-inferiority between the groups, and patients in the rhPDGF-BB/β-TCP group were found to have less pain and an improved safety profile.

Conclusions: 

In patients requiring hindfoot or ankle arthrodesis, treatment with rhPDGF-BB/β-TCP resulted in comparable fusion rates, less pain, and fewer side effects as compared with treatment with autograft.

Level of Evidence: 

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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