The Journal of Bone and Joint Surgery (American). 2006;88:1431-1441.
doi:10.2106/JBJS.E.00381
© 2006 The Journal of Bone and Joint Surgery, Inc.
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Recombinant Human BMP-2 and Allograft Compared with Autogenous Bone Graft for Reconstruction of Diaphyseal Tibial Fractures with Cortical Defects

A Randomized, Controlled Trial

Alan L. Jones, MD1, Robert W. Bucholz, MD2, Michael J. Bosse, MD3, Sohail K. Mirza, MD, MPH4, Thomas R. Lyon, MD5, Lawrence X. Webb, MD6, Andrew N. Pollak, MD7, Jane Davis Golden, PT, MHP8, Alexandre Valentin-Opran, MD8 the BMP-2 Evaluation in Surgery for Tibial Trauma–Allograft (BESTT-ALL) Study Group

1 Orthopaedic Trauma Association of North Texas, 3600 Gaston Avenue, Barnett Tower, Suite 1101, Dallas, TX 75246
2 Department of Orthopaedic Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, TX 75235
3 Department of Orthopaedic Surgery, Carolinas Medical Center, P.O. Box 32861, Charlotte, NC 28232
4 Department of Orthopaedics, Harborview Medical Center, University of Washington, 325 Ninth Avenue, Seattle, WA 98104
5 Department of Trauma Services, Lutheran Medical Center, 150 55th Street, Brooklyn, NY 11220
6 Wake Forest School of Medicine, Medical Center Boulevard, Winston-Salem, NC 27157
7 Department of Orthopaedics, University of Maryland School of Medicine, 22 South Greene Street, Suite T3R54, Baltimore, MD 21201
8 Wyeth Research, 87 CambridgePark Drive, Cambridge, MA 02140. E-mail address for J.D. Golden: jdavis{at}wyeth.com

Investigation performed at University of Texas Southwestern Medical Center, Dallas, Texas; University of Maryland School of Medicine, Baltimore, Maryland; Carolinas Medical Center, Charlotte, North Carolina; Harborview Medical Center, Seattle, Washington; Lutheran Medical Center, Brooklyn, New York; and Wake Forest School of Medicine Medical Center, Winston-Salem, North Carolina

In support of their research for or preparation of this manuscript, one or more of the authors received grants or outside funding from Wyeth Research. None of the authors received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. A commercial entity (Wyeth Research) paid or directed, or agreed to pay or direct, benefits to a research fund, foundation, educational institution, or other charitable or nonprofit organization with which seven of the authors are affiliated or associated. Two other authors are salaried employees of Wyeth Research.

A commentary is available with the electronic versions of this article, on our web site (www.jbjs.org) and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM).

Background: Currently, the treatment of diaphyseal tibial fractures associated with substantial bone loss often involves autogenous bone-grafting as part of a staged reconstruction. Although this technique results in high healing rates, the donor-site morbidity and potentially limited supply of suitable autogenous bone in some patients are commonly recognized drawbacks. The purpose of the present study was to investigate the benefit and safety of the osteoinductive protein recombinant human bone morphogenetic protein-2 (rhBMP-2) when implanted on an absorbable collagen sponge in combination with freeze-dried cancellous allograft.

Methods: Adult patients with a tibial diaphyseal fracture and a residual cortical defect were randomly assigned to receive either autogenous bone graft or allograft (cancellous bone chips) for staged reconstruction of the tibial defect. Patients in the allograft group also received an onlay application of rhBMP-2 on an absorbable collagen sponge. The clinical evaluation of fracture-healing included an assessment of pain with full weight-bearing and fracture-site tenderness. The Short Musculoskeletal Function Assessment (SMFA) was administered before and after treatment. Radiographs were used to document union, the presence of extracortical bridging callus, and incorporation of the bone-graft material.

Results: Fifteen patients were enrolled in each group. The mean length of the defect was 4 cm (range, 1 to 7 cm). Ten patients in the autograft group and thirteen patients in the rhBMP-2/allograft group had healing without further intervention. The mean estimated blood loss was significantly less in the rhBMP-2/allograft group. Improvement in the SMFA scores was comparable between the groups. No patient in the rhBMP-2/allograft group had development of antibodies to BMP-2; one patient had development of transient antibodies to bovine type-I collagen.

Conclusions: The present study suggests that rhBMP-2/allograft is safe and as effective as traditional autogenous bone-grafting for the treatment of tibial fractures associated with extensive traumatic diaphyseal bone loss.

Level of Evidence: Therapeutic Level II. See Instructions to Authors for a complete description of levels of evidence.


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Letters to the Editor:

Read all Letters to the Editor

Implication of BMPs in the development of tumors.
Fabian Krause, et al.
JBJS Online, 22 Jan 2008 [Full text]
Ms. Davis Golden et al. respond to Dr. Krause et al.
Jane Davis Golden, PT, MHP, et al.
JBJS Online, 22 Jan 2008 [Full text]