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Contemporary Alternatives to Synthetic Bone Grafts for Spine Surgery

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Contemporary Alternatives to Synthetic Bone Grafts for Spine Surgery A Review Paper Contemporary Alternatives to Synthetic Bone Grafts for Spine Surgery Jared F. Brandoff, MD, Jeff S. Silber, MD, DC, and Alexander R. Vaccaro, MD ugmentation of internal fixation in spinal fusion Abstract surgery with autogenous or allogeneic bone graft The goal in performing spinal fusion techniques is or bone graft substitutes is the sine qua non step to achieve solid fusion, which will maximize clinical in inducing successful fusion in modern spinal outcomes. This goal has generated enormous inter- Asurgery. Absence of osteoconductive, osteoinductive, and est in developing bone graft alternatives or extend- biological factors creates a hostile setting for osteogenesis, ers that enhance or replace autologous bone graft. whereas presence of such substances, in varying amounts Autogenous bone graft from the iliac crest is still the gold standard for graft materials because it and in conjunction with stability, creates a favorable has all 3 properties essential for adequate fusion. mechanical and biological environment for the successful The search for a synthetic graft as good as or bet- formation of new bone.1-4 ter than iliac crest bone graft has recently inten- Nevertheless, debate over which materials and tech- sified with the emphasis on minimizing the inva- niques result in the highest rates of successful fusion at the siveness of surgical techniques, including harvest lowest morbidity to the patient and cost to society is heat- of iliac crest autograft (such harvesting can be ed. According to data collected by the American Academy associated with significant donor site morbidity). of Orthopaedic Surgeons, more than 500,000 bone graft Increasingly being studied are biologically active procedures are performed annually in the United States. substances intended to extend, enhance, or even replace autologous graft. These substances include Of these procedures, slightly less than half are performed 5 (a) allograft cancellous chips and (b) cortical spac- as an adjunct to spinal fusion surgery. Therefore, given ers that are both osteoconductive (provide bone their great popularity and potentially large impact on scaffold) and weakly osteoinductive (promote new spinal surgery outcomes, bone graft materials and biology bone formation), including demineralized bone have become a formidable topic of research. matrix products. Human recombinant bone mor- phogenetic proteins (BMPs), including recombi- SYNTHETIC ALTERNATIVES nant human BMP-2 (rhBMP-2) and recombinant Bone biosynthesis requires cells (eg, osteoblasts), growth human osteogenic protein 1 (rhOP-1 or rhBMP-7), factors (eg, bone morphogenetic proteins [BMPs]), and an are being investigated in human clinical trials and show promise as autologous bone graft substitutes. appropriate scaffold. Use of human bone tissue, either whole Synthetic bone grafts (ceramics), such as hydroxy- or as a constituent of a composite graft (eg, demineralized apatite and b-tricalcium phosphate, provide scaffolds bone matrix [DBM]), provides one or more of these compo- similar to those of autologous bone, are plentiful and nents naturally. Synthetic bone graft substitutes are materials inexpensive, and are not associated with donor mor- that can provide the necessary components for osteogenesis bidity. Furthermore, adding silicon may increase the but that do not occur naturally. They are formed from materi- bioactivity of calcium phosphate and enhance inter- als that may have chemical and biological properties similar actions at the graft–host interface. to those of real bone but that offer other benefits, such as no or very low antigenicity, abundant supply, suitable and predictable mechanical properties, ease of use, and very low Dr. Brandoff is Orthopaedic Resident, Department of Orthopaedic risk of spreading disease. Surgery, Long Island Jewish Medical Center, New Hyde Park, Ceramic-based synthetic bone grafts capitalize on the New York. chemical composition of the inorganic phase of natural Dr. Silber is Associate Professor, Albert Einstein School of bone as a scaffold for new bone production. For example, Medicine, Department of Orthopaedic Surgery, North Shore/ hydroxyapatite (HA) has 2 properties that make it attrac- Long Island Jewish Health System, New Hyde Park, New York. Dr. Vaccaro is Professor, Department of Neurosurgery and tive as a bone graft substitute. First, it can be formed into Orthopaedic Surgery, Thomas Jefferson University, The Rothman a 3-dimensional structure that is rigid and stable. Stability Institute, Philadelphia, Pennsylvania. is conducive to new bone formation because it allows for ingrowth of bone elements (collagen and inorganic ele- Requests for reprints: Jeff S. Silber, MD, DC, Department of ments) as well as nutrient blood vessels (angiogenesis). Orthopaedic Surgery, 865 Northern Blvd, Great Neck, NY 11021 (tel, 516-465-8648; fax, 526-465-8654; [email protected]). Second, at the macroscopic level, the building blocks of HA can be organized to form micropores of ideal size Am J Orthop. 2008;37(8):410-414. Copyright Quadrant HealthCom for osteogenesis and angiogenesis. Pore diameter and the Inc. 2008. All rights reserved. degree to which pores communicate (interconnectivity) 410 The American Journal of Orthopedics® J. F. Brandoff et al Figure 1. Electron microscopy of VitossTM (Orthovita, Malvern, Figure 2. Electron microscopy of Vitoss with new bone Pa) 3-dimensional shape. Image courtesy of Orthovita. formation. Image courtesy of Orthovita. are the major determinants of the speed with which a graft with autologous iliac crest bone graft. Several other clini- will be incorporated and remodeled. Optimal pore size for cal studies have found Pro Osteon 200 fusion rates of 93% osteoconduction is 150 to 500 micrometers6; larger pores to 100% and patient satisfaction rates of approximately reduce stress shielding at the microscopic level, whereas 90%.11 Pro Osteon 500 (pore diameter, 500 micrometers) smaller pores have a role in transporting fluids containing closely resembles cancellous bone in structure but has only nutrients and oxygen through the scaffold.7 25% of the compressive strength of Pro Osteon 200. Pro When implanted graft materials fail, they fail at the inter- Osteon 500 has shown effectiveness as a graft extender in face between the implanted material and the host tissue.8 instrumented posterolateral lumbar fusion procedures.12 It is suggested that the more biocompatible an implant is The synthetic bone graft alternatives most commonly at its surface, the more efficiently it will be incorporated used are made from b-tricalcium phosphate (b-TCP).9 into new bone formation and the less likely the construct These substances are chemically similar to normal bone will fail. This is the rationale behind ceramic (HA)–based and thus have very low immunologic reaction levels. b- synthetic bone grafts; as bone in its inorganic phase is TCP resorption occurs through both phagocytosis (mac- also composed of HA, the bone–graft interface allows for rophages) and chemical dissolution. The rate at which rapid incorporation of new bone. Furthermore, the porosity phagocytosis occurs depends on the rate of particulate incorporated into HA provides the essential scaffold design debris generation by chemical dissolution. When particu- for proper bone ingrowth, thus creating a stable interface for late debris is generated in excess, a full-fledged inflamma- new bone formation. tory reaction can occur, leading to loss of ingrowing bone HA-based synthetic grafts have been used with vary- and fibrous tissue encapsulation. These processes create a ing degrees of success. Pro Osteon® (Biomet Spine, local environment rich in osteogenic substrates to be used Parsippany, NJ) is a commercially available ceramic graft by activated osteoblasts. Scaffolds made of mixtures of HA derived from sea coral. Sea coral consists primarily of cal- and b-TCP provide osteoconduction for bone production cium carbonate, which can be chemically transformed fully as well as long-term stability, leading to successful incor- or partially into HA during manufacturing. Depending on poration of a bone-fusion mass.13,14 Over time, the stable the duration of the reaction cycle, the scaffold consists tertiary structure of the HA portion of the graft does not either of a thin layer of HA over a calcium carbonate scaf- resorb, imparting structural rigidity to the fusion site while fold (resorbable in 6-18 months) or a fully reacted HA the b-TCP is resorbed. scaffold (slowly resorbing at 2%-5% per year). In addition, VitossTM (Orthovita, Malvern, Pa) is a commercially specific coral species can be selected to create implants available highly porous b-TCP ceramic bone graft alterna- with different pore sizes, thus emulating either cortical tive (Figure 1).15 Vitoss is marketed as a bone graft substi- or cancellous bone. Thalgott and colleagues9 reported tute with 90% open, interconnected porosity, resembling using Pro Osteon 200 (pore diameter, 200 micrometers) the multidirectional interconnected porosity of human in combination with rigid plating after anterior cervical cancellous bone.16 Pore sizes range from 1 to 1000 decompression and fusion of 26 patients. The reported micrometers; larger pores allow for cell seeding, migra- fusion rate after a minimum of 2 years of follow-up was tion, and bony ingrowth, whereas smaller pores encourage 100%, with mean decrease in overall pain of 76%. In a neovascularization and allow for the capillary transport of separate study of anterior cervical
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