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.
1Department 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: email@example.com
2University of Medicine & Dentistry of New Jersey, 90 Bergen Street, Suite #7300, Newark, NJ 07101
3University of Rochester, 601 Elmwood Avenue, Rochester, NY 14642
4St. Michael’s Hospital, 55 Queen Street East, Suite 800, Toronto, ON M5C 1R6, Canada
5St. Paul’s Hospital, Burrard Medical Centre, 1144 Burrard Street, Suite 560, Vancouver, BC V6Z 2A5, Canada
6Halifax Infirmary, 1796 Summer Street, Room 4867, Halifax, NS B3H 3A7, Canada
7Orthopaedic Associates of Michigan, PC, 1111 Leffingwell N.E., Suite 100, Grand Rapids, MI 49525
8OrthoCarolina Research Institute, Inc., 2001 Vail Avenue, Suite 250, Charlotte, NC 28207
9BioMimetic Therapeutics, Inc., 389 Nichol Mill Lane, Franklin, TN 37067