Biodegradable materials for bone defect repair.

Compared with non-degradable materials, biodegradable biomaterials play an increasingly important role in the repairing of severe bone defects, and have attracted extensive attention from researchers. In the treatment of bone defects, scaffolds made of biodegradable materials can provide a crawling bridge for new bone tissue in the gap and a platform for cells and growth factors to play a physiological role, which will eventually be degraded and absorbed in the body and be replaced by the new bone tissue. Traditional biodegradable materials include polymers, ceramics and metals, which have been used in bone defect repairing for many years. Although these materials have more or fewer shortcomings, they are still the cornerstone of our development of a new generation of degradable materials. With the rapid development of modern science and technology, in the twenty-first century, more and more kinds of new biodegradable materials emerge in endlessly, such as new intelligent micro-nano materials and cell-based products. At the same time, there are many new fabrication technologies of improving biodegradable materials, such as modular fabrication, 3D and 4D printing, interface reinforcement and nanotechnology. This review will introduce various kinds of biodegradable materials commonly used in bone defect repairing, especially the newly emerging materials and their fabrication technology in recent years, and look forward to the future research direction, hoping to provide researchers in the field with some inspiration and reference.

Recent Advances of Biphasic Calcium Phosphate Bioceramics for Bone Tissue Regeneration.

Biphasic calcium phosphate bioceramics consist of an intimate mixture of hydroxyapatite (HA) and beta-tricalcium phosphate (ß-TCP) in varying ratios. Due to their biocompatibility, osteoconductivity, and safety in in vitro, in vivo, and clinical models, they have become promising bone substitute biomaterials and are recommended for use as alternatives for or as additives in bone tissue regeneration in various orthopedic and dental applications. Many studies have demonstrated the potential uses of BCP bioceramics as scaffolds for tissue engineering. Here, we highlight the recent advances in the uses of BCP bioceramics and functionalized BCPs for bone tissue regeneration.

The outcome of biphasic calcium phosphate bone substitute in a medial opening wedge high tibial osteotomy.

BACKGROUND: Our objective was to assess clinical and radiological findings following a medial opening wedge high tibial osteotomy using a biphasic calcium phosphate (BCP) synthetic bone substitute, designed as a wedge with two differing zones of density. The in-vivo behaviour of this type of bone substitute over time is currently unknown. HYPOTHESIS: Our hypothesis was that BCP synthetic bone would facilitate bone union and undergo replacement with host bone over the study period. PATIENTS AND METHODS: Fifteen sequential patients were followed prospectively for minimum 4-years post-operatively. All patients were evaluated clinically using patient reported outcome measures and radiologically to evaluate alignment with maintenance of the osteotomy correction, and bone union with expected BCP dissolution. RESULTS: All patients had good clinical scores with no reported complications at 4 years. In all cases there were radiographic findings of bone union with consolidation and no loss of correction. However the graft remained densely radiopaque at final follow-up. DISCUSSIONS: This study demonstrates that a BCP graft in combination with a locking plate for a medial opening wedge HTO allows early weight-bearing, maintains correction and provides good clinical outcomes. Whilst higher densities of BCP are strong, they do not resorb fully, remaining radiographically visible. This may have implications for the performance of a future knee arthroplasty and caution should therefore be taken.

Spinal fusion procedures in the adult and young population: a systematic review on allogenic bone and synthetic grafts when compared to autologous bone.

This systematic review aims to compare clinical evidences related to autologous iliac crest bone graft (ICBG) and non-ICBG (local bone) with allografts and synthetic grafts for spinal fusion procedures in adult and young patients. A systematic search was carried out in three databases (PubMed, Scopus, Web of Science, Cochrane Central Register of Controlled Trials) to identify clinical studies in the last 10 years. The initial search retrieved 1085 studies, of which 24 were recognized eligible for the review. Twelve studies (4 RCTs, 5 prospective, 3 retrospective) were focused on lumbar spine, 9 (2 RCTs, 2 prospective, 4 retrospective, 1 case-series) on cervical spine and 3 (1 RCT, 2 retrospective) on spinal fusion procedures in young patients. Calcium phosphate ceramics, allografts, bioglasses, composites and polymers have been clinically investigated as substitutes of autologous bone in spinal fusion procedures. Of the 24 studies included in this review, only 1 RCT on cervical spine was classified with high level of evidence (Class I) and showed low risk of bias. This RCT demonstrated the safety and efficacy of the proposed treatment, a composite bone substitute, that results in similar and on some metrics superior outcomes compared with local autograft bone. Almost all other studies showed moderately or, more often, high incidence of bias (Class III), thus preventing ultimate conclusion on the hypothesized beneficial effects of allografts and synthetic grafts. This review suggests that users of allografts and synthetic grafting should carefully consider the scientific evidence concerning efficacy and safety of these bone substitutes, in order to select the best option for patient undergoing spinal fusion procedures.

Antibacterial Properties of Nanoparticles in Dental Restorative Materials. A Systematic Review and Meta-Analysis.

Background and Objectives: Nanotechnology has become a significant area of research focused mainly on increasing the antibacterial and mechanical properties of dental materials. The aim of the present systematic review and meta-analysis was to examine and quantitatively analyze the current evidence for the addition of different nanoparticles into dental restorative materials, to determine whether their incorporation increases the antibacterial/antimicrobial properties of the materials. Materials and Methods: A literature search was performed in the Pubmed, Scopus, and Embase databases, up to December 2018, following PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) guidelines for systematic reviews and meta-analyses. Results: A total of 624 papers were identified in the initial search. After screening the texts and applying inclusion criteria, only 11 of these were selected for quantitative analysis. The incorporation of nanoparticles led to a significant increase (p-value <0.01) in the antibacterial capacity of all the dental materials synthesized in comparison with control materials. Conclusions: The incorporation of nanoparticles into dental restorative materials was a favorable option; the antibacterial activity of nanoparticle-modified dental materials was significantly higher compared with the original unmodified materials, TiO2 nanoparticles providing the greatest benefits. However, the high heterogeneity among the articles reviewed points to the need for further research and the application of standardized research protocols.

Mechanical behavior of a titanium alloy scaffold mimicking trabecular structure.

BACKGROUND: Additively manufactured porous metallic structures have recently received great attention for bone implant applications. The morphological characteristics and mechanical behavior of 3D printed titanium alloy trabecular structure will affect the effects of artificial prosthesis replacement. However, the mechanical behavior of titanium alloy trabecular structure at present clinical usage still is lack of in-depth study from design to manufacture as well as from structure to mechanical function. METHODS: A unit cell of titanium alloy was designed to mimick trabecular structure. The controlled microarchitecture refers to a repeating array of unit-cells, composed of titanium alloy, which make up the scaffold structure. Five kinds of unit cell mimicking trabecular structure with different pore sizes and porosity were obtained by modifying the strut sizes of the cell and scaling the cell as a whole. The titanium alloy trabecular structure was fabricated by 3D printing based on Electron Beam Melting (EBM). The paper characterized the difference between the designs and fabrication of trabecular structures, as well as mechanical properties and the progressive collapse behavior and failure mechanism of the scaffold. RESULTS: The actual porosities of the EBM-produced bone trabeculae are lower than the designed, and the load capacity of a bearing is related to the porosity of the structure. The larger the porosity of the structure, the smaller the stiffness and the worse the load capacity is. The fracture interface of the trabecular structure under compression is at an angle of 45o with respect to the compressive axis direction, which conforms to Tresca yield criterion. The trabeculae-mimicked unit cell is anisotropy. Under quasi-static loading, loading speed has no effect on mechanical performance of bone trabecular specimens. There is no difference of the mechanical performance at various orientations and sites in metallic workspace. The elastic modulus of the scaffold decreases by 96%-93% and strength reduction 96%-91%, compared with titanium alloy dense metals structure. The apparent elastic modulus of the unit-cell-repeated scaffold is 0.39-0.618 GPa, which is close to that of natural bone and stress shielding can be reduced. CONCLUSION: We have systematically studied the structural design, fabrication and mechanical behavior of a 3D printed titanium alloy scaffold mimicking trabecula bone. This study will be benefit of the application of prostheses with proper structures and functions.

Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial.

Background and Objectives: Maxillary bone defects related to post-extraction alveolar ridge resorption are usual. These defects may lead to failure in further surgical implant phases given the lack of bone volume to perform the dental implant. The objective of this clinical assay was to evaluate the safety and efficacy of an experimental synthetic bone substitute in the preservation of post-extraction maxillary alveoli. Materials and Methods: 33 voluntary patients who had at least one maxillary premolar tooth that was a candidate for exodontia (n = 39) and subsequent implant rehabilitation participated. The regenerated alveoli were monitored by means of periodic clinical examinations (days 9 ± 1, 21 ± 4, 42 ± 6, and 84 ± 6), measuring the height and width of the alveolar crest (days 0 and 180 ± 5), measurement of radiodensity using tomographic techniques (days 0-5 and 175 ± 5), and histological examination of biopsies collected at 180 ± 5 days. Results: No significant differences were observed during the entire follow-up period between the two groups with respect to the safety variables studied. A variation in width of -0.9 ± 1.3 mm and -0.6 ± 1.5 mm, and a variation in height of -0.1 ± 0.9 mm and -0.3 ± 0.7 mm was observed for experimental material Sil-Oss® and Bio-Oss®, respectively. The radiodensity of the alveoli regenerated with the experimental material was significantly lower than that corresponding to Bio-Oss®. However, the histological study showed greater osteoid matrix and replacement of the material with newformed bone in the implanted beds with the experimental material. Conclusions: Both materials can be used safely and proved equally effective in maintaining alveolar flange dimensions, they are also histologically biocompatible, bioactive and osteoconductive. The experimental material showed the advantage of being resorbable and replaced with newformed bone, in addition to promoting bone regeneration.

Pre-Registration Assessment of Bone-Filling Products.

The use of bone-filling material to repair bone defects and fix implanted bone grafts is a developing area in medicine. Investigators can evaluate bone-filling materials through use of several indices to make comparisons and to determine suitability for application in humans1 . However, it is quite difficult to transform their discovery into practical use, because the viability of the studied material might require examination of all aspects of properties. In addition, for a material to become a product, a complete procedure involving a declaration, registration, and approval is necessary. This article introduces the technical indices that the investigators and reporters should provide in their declaration and registration data to meet the relevant standards in China. The indices include physical and chemical properties, biocompatibility, biosecurity, pre-clinical animal model tests, sterilization and disinfection, product duration, and packaging. Full consideration of all possible indices is crucial to realize the transformation from a designed product to a commercial medical device, which requires effective interaction between clinicians and engineers.

Bone Graft Displacement After Maxillary Sinus Floor Augmentation With or Without Covering Barrier Membrane: A Retrospective Computed Tomographic Image Evaluation.

PURPOSE: Scientific publications have recently found that bone graft quality and implant survival rates were not influenced by antrostomy membrane coverage during maxillary sinus floor augmentation with a lateral approach. The aim of this study was to evaluate the stability of the bone substitute after a maxillary sinus floor augmentation procedure with or without using a covering membrane. MATERIALS AND METHODS: This retrospective study evaluated all patients who were enrolled between April 2016 and January 2017. The stability of the bone graft inside the sinus cavity as well at the level of the lateral bone window was assessed through preoperative and postoperative cone beam computed tomography images up to 6-month follow-up. The clinical postoperative morbidity was evaluated following a visual analog scale (VAS) protocol. RESULTS: Maxillary sinus floor augmentation with a lateral approach was performed in 41 patients. In 17 cases (10 women/7 men, mean age: 55.4 years), a barrier membrane was used to cover the lateral bone window (control group), and in 24 cases (13 women/11 men, mean age: 56.2 years), no membrane was used (test group). The bone graft dislodgement within the buccal mucosa at 6 months postoperative ranged from 0 to 12.2 mm (mean value: 3.8 ± 3.1 [standard deviation] mm) in the test group and from 0 to 2.3 mm (mean value: 0.5 ± 0.4 mm) in the control group. The postoperative pain and swelling complications were significantly more important for the test group (3.3 ± 1.4/4.3 ± 4.5, respectively) than for the control group (2.1 ± 0.9/2.7 ± 0.9). CONCLUSION: On the basis of this preliminary study, it appears that the use of a barrier membrane to cover the lateral bone window during maxillary sinus floor augmentation surgery with a lateral approach reduces the postoperative dislodgement of the bone graft throughout the sinus antrostomy and prevents the bone substitute particles penetrating within the buccal mucosa, which is related to postoperative morbidity.

Bone augmentation using autogenous bone versus biomaterial in the posterior region of atrophic mandibles: A systematic review and meta-analysis.

OBJECTIVES: This systematic review and meta-analysis aimed to answer the PICO question: "Do patients who have received bone grafts with bone substitute (biomaterials) present bone gain (before implant installation), complications, and implant survival rates similar to autogenous grafts when used in the posterior mandible region?". DATA: This review followed the PRISMA statement and has been registered at PROSPERO (CRD42016048471). Studies published in English, randomized controlled and/or prospective clinical trials with at least 10 patients, and studies that compared grafts with bone substitutes to autogenous bone grafts (split-mouth design) were included. SOURCES: An electronic search and a manual search were conducted in PubMed/MEDLINE, Scopus, and Cochrane databases up to April 2018. STUDY SELECTION: Our initial search yielded 640 articles; we selected four articles that met the inclusion criteria. All selected studies used a split-mouth design. RESULTS: Our analysis revealed no significant difference between the biomaterial and autogenous groups in terms of bone gain (P = 0.11; mean difference [MD]: 0.59; 95% confidence interval [CI]: -0.13-1.31) or complication rate (P = 0.72; risk ratio [RR]: 1.25; 95% CI: 0.37-4.23). Sixty-six implants were installed in the biomaterial group and 63 in the autogenous group; these showed no significant difference in implant survival rate (P = 0.50; RR: 1.57; 95% CI: 0.43-5.81). CONCLUSION: We conclude that biomaterials or autogenous bone are indicated for the reconstruction of the posterior mandibular atrophic region, without lowering implant survival.

The biocompatibility of bone cements: progress in methodological approach.

The ideal bone graft substitute should have certain properties and there are many studies dealing with mixture of polymethylmetacrilate (PMMA) and ß-tricalciumphospate (ß-TCP) presenting the best characteristics of both. Scanning Electron Microscopy (SEM), for ultra-structural data, resulted a very reliable in vivo model to better understand the bioactivity of a cement and to properly evaluate its suitability for a particular purpose. The present study aims to further improve the knowledge on osteointegration development, using both parameters obtained with the Environmental Scanning Electron Microscopy (ESEM) and focused histological examination. Two hybrid bone graft substitute were designed among ceramic and polymer-based bone graft substitutes. Based on ß-TCP granules sizes, they were created with theoretical different osteoconductive properties. An acrylic standard cement was chosen as control. Cements were implanted in twelve New Zealand White (NZW) rabbits, which were sacrificed at 1, 2, 3, 6, 9 and 12 months after cement implantation. Histological samples were prepared with an infiltration process of LR white resin and then specimens were studied by X-rays, histology and Environmental Scanning Electron Microscopy (ESEM). Comparing the resulting data, it was possible to follow osteointegration's various developments resulting from different sizes of ß-TCP granules. In this paper, we show that this evaluation process, together with ESEM, provides further important information that allows to follow any osteointegration at every stage of develop.

Effect of Comonomers on Physical Properties and Cell Attachment to Silica-Methacrylate/Acrylate Hybrids for Bone Substitution.

Hybrids with a silica network covalently bonded to a polymer are promising materials for bone repair. Previous work on synthesizing methyl methacrylate (MMA) based copolymers by reversible addition-fragmentation chain transfer (RAFT) polymerization gives high tailorability of mechanical properties since sophisticated polymer structures can be designed. However, more flexible hybrids would be beneficial. Here, n-butyl methacrylate (BMA) and methyl acrylate (MA) based hybrids are produced. Unlike MMA, BMA and MA hybrids do not show plastic deformation, and BMA hybrid has strain to failure of 33%. Although the new hybrids are more flexible, preosteoblast cells do not adhere on their surfaces, due to higher hydrophobicity and lower stiffness. Comonomer choice is crucial for bone regenerative hybrids.

Biphasic calcium phosphates bioceramics (HA/TCP): Concept, physicochemical properties and the impact of standardization of study protocols in biomaterials research.

Biphasic calcium phosphates (BCP) bioceramics have become the materials of choice in various orthopedic and maxillofacial bone repair procedures. One of their main advantages is their biodegradation rate that can be modified by changing the proportional ratio of the composition phases. For enhanced bone tissue regeneration, the bioactivity of BCP should be increased by optimizing their physicochemical properties. To date, the ideal physicochemical properties of BCP for bone applications have not been defined. This is mostly related to lack of standard study protocols in biomaterial science especially with regards to their characterizations and clinical applications. In this paper we provided a review on BCP and their physicochemical properties relevant to clinical applications. In addition, we summarized the available literature on their use in animal models and evaluated the influences of different composition ratios on bone healing. Controversies in literature with regards to ideal composition ratio of BCP have also been discussed in detail. We illustrated the discrepancies in study protocols among researchers in animal studies and emphasized the need to develop and follow a set of generally accepted standardized guidelines. Finally; we provided general recommendations for future pre-clinical studies that allow better standardization of study protocols. This will allow better comparison and contrast of newly developed bone substitute biomaterials that help further progress in the field of biomaterial science.

Osteoporotic Fracture Care: Are We Closer to Gold Standards?

This review summarizes symposium presentations from the OTA's Basic Science Focus Forum on care for osteoporotic fractures. The limitations of diaphyseal osteoporotic animal bone models are discussed, together with the potential benefits of using metaphyseal models to study osteoporotic fracture fixation constructs. Metaphyseal bone repair models provide better simulation of the most common osteoporotic fractures. Selection of an osteoporotic model for mechanical testing is also challenging. One should always thoroughly define the clinical problem to be addressed. The selected model should then be validated for behavior matched to known clinical behavior with known fixation configurations. The medical management of osteoporosis is directed at enhancing bone mass, improving bone quality, and lowering fracture risk. Medical strategies to achieve these goals are discussed. The medical strategy should include provision of an adequate calcium and vitamin D environment to facilitate well-mineralized bone and improve bone quality, prevent excessive bone resorption, and provide an anabolic stimulus to enhance bone formation. Atypical femur fractures continue to be a serious issue for the orthopaedic community. Risk factors, treatment modalities, and prevention strategies are discussed. A comprehensive strategy for the improved treatment of osteoporotic fractures must address both biological and mechanical issues and includes 4 specific approaches: (1) removal of inhibitors to bone healing; (2) introduction of bone healing stimulants; (3) modification of fracture fixation constructs; and (4) application of bone augmentation or substitutes. There is currently no optimal bone substitute. Substitutes should be chosen based on the most critical need when treating a particular fracture.

In vivo comparative investigation of three synthetic graft materials with varying compositions processed using different methods.

PURPOSE: The aim of this study was to compare the osteoconductive potential and bone-healing pattern of biphasic calcium phosphates (BCPs) with varying compositions produced using different processing methods. MATERIALS AND METHODS: Ten male New Zealand white rabbits were used. Four circular defects with a diameter of 8 mm were made in the rabbit calvarium. Each defect was assigned to one of the following BCP groups: control; BCP1, 70% hydroxyapatite (HA)/30% ß-tricalcium phosphate (ß-TCP); BCP2, 30% HA/70% ß-TCP; and BCP3, 20% HA/80% ß-TCP. The rabbits were killed either 2 (n = 5) or 8 weeks (n = 5) before surgery. Histologic and histomorphometric analyses were conducted. RESULTS: The total amount of augmentation was significantly greater in the BCP groups than in the control group (P < .05). The amount of new bone formation did not differ significantly among the groups at either 2 or 8 weeks. The resorption of BCPs was significantly greater in the BCP3 group than in the BCP1 and BCP2 groups at 2 weeks, but the difference became insignificant compared with the BCP2 group at 8 weeks. The patterns of new bone formation and material resorption varied markedly among the BCP groups. New bone lined the residual particles in the BCP1 group, but filopodia-shaped new bone was observed in the BCP2 group, and collagen fragments were scattered inside the residual particles in the BCP3 group. Multiple cracklike lines were observed on the particles in the BCP3 group. CONCLUSION: The specific HA-ß-TCP ratios in the present study did not significantly influence new bone formation and space maintenance. The observed differences in healing patterns between the groups may be attributable to different physicochemical properties conferred upon the BCPs by the different processing methods used to produce them.

Effect of layer thickness and printing orientation on mechanical properties and dimensional accuracy of 3D printed porous samples for bone tissue engineering.

Powder-based inkjet 3D printing method is one of the most attractive solid free form techniques. It involves a sequential layering process through which 3D porous scaffolds can be directly produced from computer-generated models. 3D printed products' quality are controlled by the optimal build parameters. In this study, Calcium Sulfate based powders were used for porous scaffolds fabrication. The printed scaffolds of 0.8 mm pore size, with different layer thickness and printing orientation, were subjected to the depowdering step. The effects of four layer thicknesses and printing orientations, (parallel to X, Y and Z), on the physical and mechanical properties of printed scaffolds were investigated. It was observed that the compressive strength, toughness and Young's modulus of samples with 0.1125 and 0.125 mm layer thickness were more than others. Furthermore, the results of SEM and µCT analyses showed that samples with 0.1125 mm layer thickness printed in X direction have more dimensional accuracy and significantly close to CAD software based designs with predefined pore size, porosity and pore interconnectivity.

Potential lack of "standardized" processing techniques for production of allogeneic and xenogeneic bone blocks for application in humans.

In the present study, the structure of two allogeneic and three xenogeneic bone blocks, which are used in dental and orthopedic surgery, were histologically analyzed. The ultimate goal was to assess whether the components postulated by the manufacturer can be identified after applying conventional histological and histochemical staining techniques. Three samples of each material, i.e. allogeneic material-1 and -2 as well as xenogeneic material-1, -2 and -3, were obtained commercially. After decalcification and standardized embedding processes, conventional histological staining was performed in order to detect inorganic matrix, cellular or organic matrix components. Allogeneic material-1 showed trabecular bone-like structures, which were free of cellular components as well as of organic matrix. The allogeneic material-2 showed trabecular bone structures, in which connective tissue and cellular remnants were embedded. Additionally, some connective tissue, which resembled fat-like tissue, was found within this material. The xenogeneic material-1 showed trabecular bone-like structures and contained organic components comparable to that demonstrated for the allogeneic material-2. The xenogeneic material-2 showed trabecular bone structures with single cells located in lacunae. The xenogeneic material-3 also showed trabecular structures. Neither cellular nor organic matrix components were found within this material. According to the data of the present study, the allogeneic material-1 and the xenogeneic material-3 were the only investigated materials for which the obtained histological data were in accordance with the manufacturers advertised information. The remaining three materials showed discrepancies-although the manufacturers of all five bone substitute materials stated that their blocks were free of organic/cellular remnants. These data are of great clinical and material science interest. It seems that even patented processing techniques are not always able to deliver reproducible materials. Although the manufacturers of all five bone blocks stated that their blocks were free of organic/cellular remnants, our histological analysis revealed that three out of five bone blocks did contain such remnants. Such specimens might be able to induce an immune response within the recipient.

One-year volume stability of human facial defects filled with a ß-tricalcium phosphate-hydroxyl apatite mixture (Atlantik).

INTRODUCTION: We investigated the applicability and 1-year stability of a ß-tricalcium phosphate-hydroxyl apatite mixture (Atlantik) for secondary reconstruction of craniofacial defects and the application of OsiriX in evaluating bone and implant volumes. METHODS: We included 6 patients (25-59 years) with craniofacial defects. A computed tomography scan was made preoperative, directly postoperative, and at least 1 year postoperative to evaluate volume changes. OsiriX was used to quantify volumes of the implanted Atlantik. Measurements were performed by 2 independent investigators and analyzed by calculating both Pearson correlation and interclass correlation coefficient. RESULTS: After 1 year, the mean volume reduction of the implanted Atlantik was 9.8%. The absolute volume reduction in 1 year was 0.38 cm (range, 0.10-0.69 cm(3)). Pearson correlation test was 0.996, with a significance level of P < 0.01, and the interclass correlation coefficient was 0.998. CONCLUSIONS: Atlantik is a stable osteoconductive material for the repair of various craniofacial defects. There is a reduction of only 10% of the augmented volume in the long term. Applying OsiriX for computed tomography image volume analysis proved to be a well-reproducible technique.

Bone products in surgery: a blueprint for standardization.

Surgical facilities often stock many types of bone and bone products to meet the needs of multiple surgeons. In this era of cost containment, product standardization is necessary for the financial well-being of health care facilities. By familiarizing themselves with bone and bone product harvesting and processing and the US Food and Drug Administration requirements for approval of these products, perioperative nurses and managers can more easily standardize the bone and tissue products stocked and reduce costs. Steps toward standardization include establishing a multidisciplinary surgical product use committee to evaluate products used in the OR, limiting the number of tissue vendors for the facility to as few as possible, completing a product inventory to identify what is currently available, and constructing charts to share with surgeons that provide the rationales for standardizing products.

Assessment of MASTERGRAFT PUTTY as a graft extender in a rabbit posterolateral fusion model.

STUDY DESIGN: Randomized, controlled study in a laboratory setting. Blinded observations/assessment of study outcomes. OBJECTIVE: The purpose of this study was to determine the performance characteristics of MASTERGRAFT PUTTY as a bone graft extender in a rabbit posterolateral spine fusion model. SUMMARY OF BACKGROUND DATA: The rabbit posterolateral fusion model is an established environment for testing of fusion concepts. It offers the opportunity to obtain radiographical, histological, and biomechanical data on novel fusion materials. METHODS: Thirty-six rabbits were entered into the study with 30 used for analysis. Bilateral posterolateral lumbar intertransverse fusions were performed at L5-L6. The lateral two-thirds of the transverse processes were decorticated and covered with graft material: autograft only (2.5-3.0 cc per side), 25% MASTERGRAFT PUTTY/75% autograft (3.0 cc total per side), or 50% MASTERGRAFT PUTTY and 50% autograft (3.0 cc total per side). Animals were humanely killed at 8 weeks postsurgery. RESULTS: The autograft group had a 63% radiographical fusion rate (5 of 8) and correlated with manual palpation results (63%). The 25% MASTERGRAFT PUTTY group had a 73% radiographical fusion rate (8 of 11) and a manual palpation fusion rate of 64%. The 50% MASTERGRAFT PUTTY group demonstrated a 91% (10 of 11) radiographical fusion rate and 73% manual palpation fusion rate. Histologically, no inflammatory reactions were evident regardless of implant. The 2 MASTERGRAFT PUTTY groups had new bone in direct apposition to the MASTERGRAFT ceramic granules. CONCLUSION: In this commonly used rabbit posterolateral fusion model, MASTERGRAFT PUTTY in an autograft extender mode produces clinically and radiographically similar results to autograft fusion alone.