Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): An alternative to autogenous bone graft

Christopher W. DiGiovanni; Sheldon S. Lin; Judith F. Baumhauer; Timothy Daniels; Alastair Younger; Mark Glazebrook; John Anderson; Robert Anderson; Peter Evangelista; Samuel E. Lynch; Nicholas A. Abidi; Jorge I. Acevedo; Wayne Berberian; Gregory C. Berlet; Christopher Bibbo; Donald Bohay; Bradley J. Brainard; Bruce Cohen; W. Hodges Davis; Keith Donatto; Hugh Dougall; Mark E. Easley; Andrew A. Elliott; Adolph Samuel Flemister; William Granberry; Justin Greisberg; Steven L. Haddad; Anthony Hinz; Susan N. Ishikawa; Juha I. Jaakkola; Johnny Lau; Ian Le; Thomas Lee; John Maskill; G. Andrew Murphy; Steven K. Neufeld; M. J. O'Malley; Murray Penner; Terrence Philbin; Michael Pinzur; Steven Raikin; Iain Russell; Lew Schon; James J. Sferra; Naomi Shields; Nebojsa Skrepnik; Raymond Sullivan; Michael Swords; A. Brian Thomson; Troy Watson; Kevin Wing

doi:10.2106/JBJS.K.01422

Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): An alternative to autogenous bone graft

Christopher W. DiGiovanni
, Sheldon S. Lin
, Judith F. Baumhauer
, Timothy Daniels
, Alastair Younger
, Mark Glazebrook
, John Anderson
, Robert Anderson
, Peter Evangelista
, Samuel E. Lynch
, Nicholas A. Abidi
, Jorge I. Acevedo
, Wayne Berberian
, Gregory C. Berlet
, Christopher Bibbo
, Donald Bohay
, Bradley J. Brainard
, Bruce Cohen
, W. Hodges Davis
, Keith Donatto

Hugh Dougall, Mark E. Easley, Andrew A. Elliott, Adolph Samuel Flemister, William Granberry, Justin Greisberg, Steven L. Haddad, Anthony Hinz, Susan N. Ishikawa, Juha I. Jaakkola, Johnny Lau, Ian Le, Thomas Lee, John Maskill, G. Andrew Murphy, Steven K. Neufeld, M. J. O'Malley, Murray Penner, Terrence Philbin, Michael Pinzur, Steven Raikin, Iain Russell, Lew Schon, James J. Sferra, Naomi Shields, Nebojsa Skrepnik, Raymond Sullivan, Michael Swords, A. Brian Thomson, Troy Watson, Kevin Wing

New Jersey Medical School (NJMS), Orthopaedics

Rutgers, The State University

Research output: Contribution to journal › Article › peer-review

79 Scopus citations

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.

Original language	American English
Pages (from-to)	1184-1192
Number of pages	9
Journal	Journal of Bone and Joint Surgery
Volume	95
Issue number	13
DOIs	https://doi.org/10.2106/JBJS.K.01422
State	Published - Jul 3 2013

ASJC Scopus subject areas

Surgery
Orthopedics and Sports Medicine

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10.2106/JBJS.K.01422

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DiGiovanni, C. W., Lin, S. S., Baumhauer, J. F., Daniels, T., Younger, A., Glazebrook, M., Anderson, J., Anderson, R., Evangelista, P., Lynch, S. E., Abidi, N. A., Acevedo, J. I., Berberian, W., Berlet, G. C., Bibbo, C., Bohay, D., Brainard, B. J., Cohen, B., Davis, W. H., ... Wing, K. (2013). Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): An alternative to autogenous bone graft. Journal of Bone and Joint Surgery, 95(13), 1184-1192. https://doi.org/10.2106/JBJS.K.01422

@article{44e418bf50d24c1c9a5c1dbe1a7da4f5,

title = "Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): An alternative to autogenous bone graft",

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.",

author = "DiGiovanni, \{Christopher W.\} and Lin, \{Sheldon S.\} and Baumhauer, \{Judith F.\} and Timothy Daniels and Alastair Younger and Mark Glazebrook and John Anderson and Robert Anderson and Peter Evangelista and Lynch, \{Samuel E.\} and Abidi, \{Nicholas A.\} and Acevedo, \{Jorge I.\} and Wayne Berberian and Berlet, \{Gregory C.\} and Christopher Bibbo and Donald Bohay and Brainard, \{Bradley J.\} and Bruce Cohen and Davis, \{W. Hodges\} and Keith Donatto and Hugh Dougall and Easley, \{Mark E.\} and Elliott, \{Andrew A.\} and Flemister, \{Adolph Samuel\} and William Granberry and Justin Greisberg and Haddad, \{Steven L.\} and Anthony Hinz and Ishikawa, \{Susan N.\} and Jaakkola, \{Juha I.\} and Johnny Lau and Ian Le and Thomas Lee and John Maskill and Murphy, \{G. Andrew\} and Neufeld, \{Steven K.\} and O'Malley, \{M. J.\} and Murray Penner and Terrence Philbin and Michael Pinzur and Steven Raikin and Iain Russell and Lew Schon and Sferra, \{James J.\} and Naomi Shields and Nebojsa Skrepnik and Raymond Sullivan and Michael Swords and Thomson, \{A. Brian\} and Troy Watson and Kevin Wing",

year = "2013",

month = jul,

day = "3",

doi = "10.2106/JBJS.K.01422",

language = "American English",

volume = "95",

pages = "1184--1192",

journal = "Journal of Bone and Joint Surgery",

issn = "0021-9355",

publisher = "Lippincott Williams and Wilkins",

number = "13",

}

DiGiovanni, CW, Lin, SS, Baumhauer, JF, Daniels, T, Younger, A, Glazebrook, M, Anderson, J, Anderson, R, Evangelista, P, Lynch, SE, Abidi, NA, Acevedo, JI, Berberian, W, Berlet, GC, Bibbo, C, Bohay, D, Brainard, BJ, Cohen, B, Davis, WH, Donatto, K, Dougall, H, Easley, ME, Elliott, AA, Flemister, AS, Granberry, W, Greisberg, J, Haddad, SL, Hinz, A, Ishikawa, SN, Jaakkola, JI, Lau, J, Le, I, Lee, T, Maskill, J, Murphy, GA, Neufeld, SK, O'Malley, MJ, Penner, M, Philbin, T, Pinzur, M, Raikin, S, Russell, I, Schon, L, Sferra, JJ, Shields, N, Skrepnik, N, Sullivan, R, Swords, M, Thomson, AB, Watson, T & Wing, K 2013, 'Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): An alternative to autogenous bone graft', Journal of Bone and Joint Surgery, vol. 95, no. 13, pp. 1184-1192. https://doi.org/10.2106/JBJS.K.01422

TY - JOUR

T1 - Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP)

T2 - An alternative to autogenous bone graft

AU - DiGiovanni, Christopher W.

AU - Lin, Sheldon S.

AU - Baumhauer, Judith F.

AU - Daniels, Timothy

AU - Younger, Alastair

AU - Glazebrook, Mark

AU - Anderson, John

AU - Anderson, Robert

AU - Evangelista, Peter

AU - Lynch, Samuel E.

AU - Abidi, Nicholas A.

AU - Acevedo, Jorge I.

AU - Berberian, Wayne

AU - Berlet, Gregory C.

AU - Bibbo, Christopher

AU - Bohay, Donald

AU - Brainard, Bradley J.

AU - Cohen, Bruce

AU - Davis, W. Hodges

AU - Donatto, Keith

AU - Dougall, Hugh

AU - Easley, Mark E.

AU - Elliott, Andrew A.

AU - Flemister, Adolph Samuel

AU - Granberry, William

AU - Greisberg, Justin

AU - Haddad, Steven L.

AU - Hinz, Anthony

AU - Ishikawa, Susan N.

AU - Jaakkola, Juha I.

AU - Lau, Johnny

AU - Le, Ian

AU - Lee, Thomas

AU - Maskill, John

AU - Murphy, G. Andrew

AU - Neufeld, Steven K.

AU - O'Malley, M. J.

AU - Penner, Murray

AU - Philbin, Terrence

AU - Pinzur, Michael

AU - Raikin, Steven

AU - Russell, Iain

AU - Schon, Lew

AU - Sferra, James J.

AU - Shields, Naomi

AU - Skrepnik, Nebojsa

AU - Sullivan, Raymond

AU - Swords, Michael

AU - Thomson, A. Brian

AU - Watson, Troy

AU - Wing, Kevin

PY - 2013/7/3

Y1 - 2013/7/3

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/84883707381

UR - https://www.scopus.com/pages/publications/84883707381#tab=citedBy

U2 - 10.2106/JBJS.K.01422

DO - 10.2106/JBJS.K.01422

M3 - Article

C2 - 23824386

SN - 0021-9355

VL - 95

SP - 1184

EP - 1192

JO - Journal of Bone and Joint Surgery

JF - Journal of Bone and Joint Surgery

IS - 13

ER -

Recombinant human platelet-derived growth factor-BB and beta-tricalcium phosphate (rhPDGF-BB/β-TCP): An alternative to autogenous bone graft

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