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Percutaneous Injection of Recombinant Human Bone Morphogenetic Protein-2 in a Calcium Phosphate Paste Accelerates Healing of a Canine Tibial Osteotomy
Ryland B. EdwardsIII, DVM, MS, PhD1; Howard J. Seeherman, PhD, VMD2; John J. Bogdanske, BS1; Jennifer Devitt, BS1; Ray VanderbyJr., PhD3; Mark D. Markel, DVM, PhD1
1 Comparative Orthopaedic Research Laboratory, Departments of Surgical Sciences (R.B.E.III) and Medical Sciences (J.J.B., J.D., and M.D.M.), School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI 53706-1102. E-mail address for R.B. Edwards III: edwardsr@svm.vetmed.wisc.edu
2 Wyeth Discovery Research, 200 Cambridge Park Drive, Cambridge, MA 02140
3 Department of Orthopedics and Rehabilitation, Clinical Science Center, University of Wisconsin-Madison, 600 Highland Avenue, Madison, WI 53792
View Disclosures and Other Information
In support of their research or preparation of this manuscript, R.B. Edwards III, J.J. Bogdanske, J. Devitt, M.D. Markel, and R. Vanderby Jr. received grants or outside funding from Wyeth. In addition, H.J. Seeherman received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity (Wyeth). Also, a commercial entity (Wyeth) paid or directed, or agreed to pay or direct, benefits to an educational institution (University of Wisconsin Regents) with which the authors are affiliated or associated.
Investigation performed at the Comparative Orthopaedic Research Laboratory, School of Veterinary Medicine, University of Wisconsin-Madison, Madison, Wisconsin

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2004 Jul 01;86(7):1425-1438
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Abstract

Background: In this study, we evaluated the capacity of a single percutaneous injection of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered in a rapidly resorbable calcium phosphate paste (a-BSM) to accelerate bone-healing in a canine tibial osteotomy model. We hypothesized that the osteotomy sites would heal faster after percutaneous delivery of rhBMP-2/a-BSM than they would after injection of a-BSM alone or after no treatment.

Methods: Bilateral tibial osteotomy was performed and the sites were stabilized with external fixators in sixteen dogs. Four hours after the surgery, one limb of each dog was treated with a single percutaneous injection of rhBMP-2/a-BSM paste or an equal volume of a-BSM alone. There were eight limbs in each group, and the osteotomy site in the contralateral limb served as an untreated control. The results were evaluated with serial radiography and force-plate analysis at four and eight weeks after surgery and with mechanical testing and histologic examination at eight weeks after the surgery.

Results: At four and eight weeks after the osteotomy and treatment, the scores for radiographic union were significantly greater for the rhBMP-2/a-BSM-treated limbs than they were for the a-BSM-treated or untreated, control limbs (p < 0.05). The callus area in the rhBMP-2/a-BSM-treated limbs was significantly greater than that in the a-BSM-treated and untreated, control limbs at four and eight weeks postinjection (p < 0.05). The time-integrated vertical force for the rhBMP-2-treated limbs was significantly greater than that for their contralateral controls at four weeks and significantly greater than that for the treated and control limbs of the a-BSM-treated dogs at four and eight weeks after the surgery (p = 0.05). The rhBMP-2-treated limbs were significantly stiffer in bending and in torsion (p < 0.05) compared with the a-BSM-treated and control limbs. Histologic analysis demonstrated increased bone formation and more mature bone at the osteotomy site in the rhBMP-2-treated limbs compared with that in the a-BSM-treated and control limbs.

Conclusions: This study demonstrates the capacity of a single percutaneous injection of rhBMP-2 delivered in a resorbable calcium phosphate paste (a-BSM) four hours after surgery to accelerate the healing of tibial osteotomy sites in a canine model.

Clinical Relevance: A single percutaneous injection of rhBMP-2/a-BSM may be useful as an adjuvant treatment to accelerate healing of bone defects similar to those created in this study.

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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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