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Results for “Bone Substitutes”

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PubMed1994

Anterior cervical discectomy and fusion using a porous hydroxyapatite bone graft substitute.

OBJECTIVES: This study analyzed the use of a coral hydroxyapatite bone substitute for use in ACDF both with and without an anterior cervical plate. STUDY DESIGN: The healing of multilevel anterior cervical fusions was tested using a goat model. Comparisons were drawn with histologic, radiographic, and biomechanical test data. METHODS: Forty-nine mature alpine goats had three-level anterior discectomies performed. Seven treatment groups of seven goats each were used; Group I with no fusion, Group IIa having tricortical iliac crest autograft, Group IIb having autograft plus an anterior plate, Group IIIa having tricortical iliac crest fresh-frozen allograft, Group IIIb having allograft plus an anterior plate, Group IVa having rectangular-shaped implants of porous hydroxyapatite, and Group IVb having ProOsteon 500 implants with an anterior cervical plate. RESULTS: Histologically, at 12 weeks 48% of the ProOsteon (Interpore, Irvine, CA) implants were rated as incorporated, 10% as possessing a fibrous gap, 29% as collapsed, and 14% as extruded. Anterior cervical plating improved the results with 71% of the implants showing good incorporation, 24% with collapse, and 5% with a fibrous gap. These histologic results compare favorably with autogenous bone and are improved over allograft bone. Fluorochrome analysis showed that none of the implants had complete turnover with host bone, but that all possessed peripheral creeping substitution with cutting cones of new bone formation at 12 weeks. Biomechanically, the spines using the ProOsteon implant were less stiff in torsion than autograft, but equal in stiffness to allograft. Flexion-extension neutral zone stiffness was lower in the ProOsteon implant group than either allograft or autograft. CONCLUSIONS: The use of a coral-based hydroxyapatite bone graft substitute for anterior cervical fusions led to significant rates of implant collapse at 12 weeks but showed excellent biologic compatibility with good early creeping substitution of the implant by host bone. The concomitant use of an anterior cervical plate with the implant prevents extrusion.

Animals↗

PubMed2006

The application of bone graft substitutes for alveolar ridge preservation after orthodontic extractions and for augmentation of residual cleft defects.

The use of bone substitute materials in orthodontics is to be considered prior to orthodontic space closure after tooth extraction during the treatment of marked crowding as well as for treatment of residual defects in cleft-lip-and-palate children. In both cases the common objective is structure preservation or augmentation of the alveolar ridge. The demands to be made on the synthetic bone graft substitute comprise not just complication-free and safe use but also the chance of early tooth movement into the treated defect area with sufficient stability of the new tooth position.

Alveolar Ridge Augmentation↗

PubMed2006

Healing of an ulnar defect using a proprietary TCP bone graft substitute, JAX, in association with autologous osteogenic cells and growth factors.

Currently, available synthetic bone substitutes have adequate osteoconductive properties but have little or no osteoinductivity. Recent research has focused on using osteogenic growth factors or cells to provide this. JAX is a beta tricalcium phosphate bone graft substitute that has a novel shape and interlocking design. This study investigated delivery methods and the use of autologous cell therapy to enhance healing of a bone defect using JAX as a scaffold. Bone marrow was harvested from 24 New Zealand White rabbits. The mononuclear cell fraction was isolated and culture expanded. Bilateral 1.5 cm defects in the ulna were filled with: Group 1: JAX alone, Group 2: JAX plus 1x10(7) autologous BMSCs injected at the time of surgery, Group 3: JAX plus 8x10(6) autologous BMSCs cultured on granules for 14 days prior to surgery, Group 4: JAX plus fresh bone marrow (BMA), Group 5: cortical autograft, Group 6: JAX plus 2.5 microg VEGF. Radiographs demonstrated that there was more new bone in the BMA and VEGF groups compared to JAX alone. Groups containing autologous BMSCs were only slightly better than JAX alone in the amount of bone in the defect but did improve bridging of the osteotomy. Histomorphometry identified a significant increase in bone volume in the BMA group compared to JAX alone. BMA and VEGF enhanced healing of bone defects whereas expanded BMSCs provided little advantage over scaffold alone. There was no difference between delivery methods of autologous BMSCs. These observations suggest that the provision of osteogenic cells alone is insufficient to enhance bone healing and that additional factors are required to initiate this process in vivo.

Animals↗

PubMed2005

Bone graft substitutes: osteobiologics.

Future devolvement of osteobiologic materials will no doubt replace materials currently being used. As techniques to improve biointegration and manipulation of the healing environment proceed, future graft substitutes may exceed even autogenous bone in their reliability. The primary role of bone graft use in foot and ankle surgery has been to fill traumatic defects and benign tumors or to augment arthrodesis techniques. This article highlights the osteobiologics in use today, including calcium-based ceramics, hydroxyapatite, calcium phosphates and calcium composite materials, collagen composite materials, calcium sulfate, calcium cements, and allograft.

Ankle↗

PubMed2003

Fibrin sealants and platelet preparations in bone and periodontal healing.

Fibrin sealants and platelet concentrates have been used alone or in association with bone substitutes to promote bone healing in orthopedic and oral surgery. Commercial fibrin sealants are homologous plasma-derived products that mimic the last step of a coagulation cascade, leading to a fibrin clot. They are used for topical hemostasis and tissue sealing and as melting agents for particulate bone substitutes. Infectious risk led to the development of autologous fibrin sealants from the patient's own plasma. However, their fabrication results in less reproducible or less satisfactory rheologic properties. The use of autologous products with high platelet concentrations, such as platelet-rich plasma, platelet concentrate, and platelet gels, has recently been suggested for combining the fibrin sealant properties with the growth factor effects of platelets. We describe the characteristics and limitations of fibrin sealants (commercial/autologous) and platelet preparations and review their effects on bone and periodontal healing as reported in experimental studies and clinical trials.

Animals↗

PubMedDate not supplied

Use of bone-graft substitutes in distal radius fractures.

The development of bone-graft substitutes potentially provides the benefits of bone grafting without the risks of autograft harvest. During the past few years, the US Food and Drug Administration has approved several different types of products. These vary considerably in composition, structural strength, osteoinductive and osteoconductive potential, and mechanisms and rates at which they are resorbed or remodeled. The products now approved for orthopaedic applications in the United States include those based on naturally occurring materials (e.g., demineralized human bone matrix, bovine collagen mineral composites, and processed coralline hydroxyapatite) as well as synthetic materials (e.g., calcium sulfate pellets, bioactive glass, and calcium phosphate cement). Materials in development include variations on available products and a new generation of biologically active materials employing growth factors. Rigorous comparison of the products is difficult, as there are no universally accepted preclinical assays and comparable clinical studies. Despite the limitations of the data now available, controlled studies and anecdotal reports suggest that use of bone-graft substitutes may result in improved treatment outcomes for patients with fractures of the distal radius.

Animals↗

PubMed2004

Systematic review of survival rates for implants placed in the grafted maxillary sinus.

Based on a systematic review of the literature from 1986 to 2002, this study sought to determine the survival rate of root-form dental implants placed in the grafted maxillary sinus. Secondary goals were to determine the effects of graft material, implant surface characteristics, and simultaneous versus delayed placement on survival rate. A search of the main electronic databases was performed in addition to a hand search of the most relevant journals. All relevant articles were screened according to specific inclusion criteria. Selected papers were reviewed for data extraction. The search yielded 252 articles applicable to sinus grafts associated with implant treatment. Of these, 39 met the inclusion criteria for qualitative data analysis. Only 3 of the articles were randomized controlled trials. The overall implant survival rate for the 39 included studies was 91.49%. The database included 6,913 implants placed in 2,046 subjects with loaded follow-up time ranging from 12 to 75 months. Implant survival was 87.70% with grafts of 100% autogenous bone, 94.88% when combining autogenous bone with various bone substitutes, and 95.98% with bone grafts consisting of bone substitutes alone. The survival rate for implants having smooth and rough surfaces was 85.64% and 95.98%, respectively. Simultaneous and delayed procedures displayed similar survival rates of 92.17% and 92.93%, respectively. When implants are placed in grafted maxillary sinuses, the performance of rough implants is superior to that of smooth implants. Bone-substitute materials are as effective as autogenous bone when used alone or in combination with autogenous bone. Studies using a split-mouth design with one variable are needed to further validate the findings.

Alveolar Ridge Augmentation↗

PubMed1998

[Bone transplantation and bone replacement materials].

There is a growing need for immediately available material with appropriate qualities for reconstruction of large bone defects. Autologous spongy bone grafts are optimal as to biocompatibility, but are in short supply. Allogenic and xenogenic bone grafts evoke an immunological reaction after implantation and are not biocompatible. In the last thirty years ceramic implants and composites have been developed for bone substitution. New calcium phosphate bone substitutes undergo processes of resorption and precipitation of carbonate apatite that play a part in formation of new bone. These materials are easy to use because of their pastelike consistence. Resorption properties are influenced by particle size, crystallinity and composition. So far, no serious adverse reactions were reported. More clinical experience is necessary especially with composites and combinations with antibiotics, bone growth factors and collagen, to specify the place of these modern calcium phosphates in bone replacement and bone substitution.

Apatites↗

PubMed2006

[Preparation and characterization of a new injectable bone substitute-carrageenan/nano-hydroxyapatite/collagen].

OBJECTIVE: To develop a new injectable biomaterial carrageenan/nano-hydroxyapatite/collagen (nHAC/Carr) for bone surgery and characterize it. METHODS: nHAC/Carr was developed by filling carrageenan with nano-hydroxyapatite/collagen (nHAC) granules. RESULTS: It was found that nHAC/Carr had similar X-ray diffraction patterns with that of nHAC. Fourier transform infrared spectroscopy showed that carrageenan did not change its structure in nHAC/Carr. The rheological behavior of nHAC/Carr was the same as carrageenan. The scanning electron microscopy and porosity analysis showed that nHAC/Carr had porous structure and its porosity was about 90%. CONCLUSION: The biomaterial nHAC/Carr may be used as an injectable bone substitute.

Bone Substitutes↗

PubMed2000

Osteoinductive bone graft substitutes.

This review will summarize the major efforts currently underway to develop osteoinductive bone graft substitutes for minimally invasive spine fusions. The primary categories of substitute include purified bone growth factors, recombinant bone growth factors, and growth factors delivered by gene therapy approaches. Clinical trials are underway for the purified and recombinant bone growth factors and pre-clinical studies have yielded promising results for a variety of gene therapy techniques for generating bone.

Bone Morphogenetic Proteins↗

PubMed1997

Evaluation of bovine-derived bone protein with a natural coral carrier as a bone-graft substitute in a canine segmental defect model.

The efficacy of a bone-graft substitute (bovine-derived bone protein in a carrier of natural coral) in the healing of a segmental defect of a weight-bearing long bone was evaluated. Twenty dogs, divided into two groups, underwent bilateral radial osteotomies with creation of a 2.5 cm defect. On one side of each dog, the defect was filled with autogenous cancellous bone graft. Contralateral defects received, in a blinded randomized fashion, cylindrical implants consisting of natural coral (calcium carbonate) or calcium carbonate enhanced with a standard dose of bovine-derived bone protein (3.0 mg/implant; 0.68 mg bone protein/cm3). The limbs were stabilized with external fixators, and all animals underwent monthly radiographs. They were killed at 12 (group 1) or 24 (group 2) weeks, and regenerated bone was studied by biomechanical testing and histology. Radiographic union developed in all 20 radii with autogenous cancellous bone grafts and in all 10 of the radii with the composite implants. None of the radii with implants of calcium carbonate alone showed radiographic evidence of union. This represented a statistically significant difference between implant types. In addition, calcium carbonate implants both with and without bone protein demonstrated radiographic evidence of near total resorption of the radiodense carrier by 12 weeks. This resorption facilitated radiographic evaluation of healing. Mean values for biomechanical parameters of radii with the composite implants exceeded those for the contralateral controls at 12 and 24 weeks; the difference was statistically significant at 12 weeks. Histology revealed scant residual calcium carbonate carrier at either time in the defects with calcium carbonate implants; however, a moderate amount was present in defects with the composite implants. In these specimens, the residual carrier was completely surrounded by newly formed bone that may have insulated the calcium carbonate from further degradation. The present study used a carrier of granular calcium carbonate reconstituted with bovine type-I collagen to deliver an osteoinductive protein to the defect site. This carrier is of nonhuman origin (eliminating the risk of disease transmission or antigenicity) and resorbs rapidly. In this model, bovine-derived bone protein in a natural coral carrier performed consistently better than the gold standard autogenous cancellous bone graft in terms of the amount of bone formation and strength of the healed defect. This may have implications for removal of hardware or resumption of weight-bearing in certain clinical situations. These data also indicate that coralline calcium carbonate alone represents a poor option as a bone-graft substitute in this critical-sized segmental defect model.

Animals↗

PubMed2002

Nonallograft osteoconductive bone graft substitutes.

An estimated 500,000 to 600,000 bone grafting procedures are done annually in the United States. Approximately (1/2) of these surgeries involve spinal arthrodesis whereas 35% to 40% are used for general orthopaedic applications. Synthetic bone graft substitutes currently represent only 10% of the bone graft market, but their share is increasing as experience and confidence in their use are accrued. Despite 15 to 20 years of clinical experience with various synthetic substitutes, there have been few welldesigned, controlled clinical trials of these implants. Synthetic bone graft substitutes consist of hydroxyapatite, tricalcium phosphate, calcium sulfate, or a combination of these minerals. Their fabrication technique, crystallinity, pore dimensions, mechanical properties, and resorption rate vary. All synthetic porous substitutes share numerous advantages over autografts and allografts including their unlimited supply, easy sterilization, and storage. However, the degree to which the substitute provides an osteoconductive structural framework or matrix for new bone ingrowth differs among implants. Disadvantages of ceramic implants include brittle handling properties, variable rates of resorption, poor performance in diaphyseal defects, and potentially adverse effects on normal bone remodeling. These inherent weaknesses have refocused their primary use to bone graft extenders and carriers for pharmaceuticals. The composition, histologic features, indications, and clinical experience of several of the synthetic bone graft substitutes approved for orthopaedic use in the United States are reviewed.

Animals↗

PubMedDate not supplied

Comparative fixation of tibial plateau fractures using alpha-BSM, a calcium phosphate cement, versus cancellous bone graft.

OBJECTIVES: To compare the compressive strength of a bone substitute material (alpha-BSM) to cancellous bone when used to fill a defect void in a cadaver model of a Schatzker II split depression fracture of the lateral tibial plateau. DESIGN: Randomized, paired design. SETTING: Biomedical engineering laboratory. PATIENTS: Twenty-six human tibias were harvested from 13 cadavers. Three pairs of tibia fractured during preparation and were excluded. The remaining 10 matched pairs were randomized to fixation by using the bone substitute material or cancellous bone. INTERVENTION: A split depression fracture of the lateral tibial plateau was created in each tibia by using reproducible methods. This fracture was stabilized with a stainless steel L-plate and screws and either alpha-BSM or cancellous bone to fill the defect void. MAIN OUTCOME MEASUREMENTS: Stiffness of the elevated fragment in compression, total depression of the joint at 1000 N. RESULTS: The alpha-BSM bone substitute displayed significantly greater stiffness than cancellous bone constructs in Schatzker II split depression fractures of the lateral tibial plateau (P < 0.0001). Plateau defects displaced significantly less at 1000 N when using alpha-BSM in comparison to cancellous bone (P < 0.0001). CONCLUSIONS: In this cadaveric study, alpha-BSM is an effective bone substitute compared with cancellous bone graft for stabilizing split depression fractures of the lateral tibial plateau.

Bone Cements↗

PubMed2001

[In vitro assessment of combining osteogenic cells with macroporous calcium-phosphate ceramics].

PURPOSE OF THE STUDY: Bone grafts or bone substitutes are required to fill bone defects resulting from trauma or surgical resection of tumors. Calcium-phosphate ceramics are synthetic bone substitutes which promote new bone formation by osteoconduction. These ceramics possess osteoconductive properties but have no intrinsic osteoinductive capacity. They are unable to induce new bone formation in extraossesous sites. One solution to develop bone substitutes with osteogenic properties would be to associate biomaterials with osteoprogenitors. MATERIALS AND METHODS: We studied the in vitro osteogenic potential of human bone-marrow cells cultured on macroporous calcium phosphate (CaP) ceramic, examining stromal cell proliferation and differentiation. Osteogenic differentiation was evaluated in terms of alkaline phosphatase activity and immunological characterization of the extracellular fibrillar matrix formed by these cells. The specimens were examined by scanning and transmission electron microscopy. RESULTS: Human bone-marrow cells proliferated on CaP ceramic. The proliferating bone-marrow cells expressed an osteoblastic phenotype as shown by alkaline phosphatase activity and synthesis in ceramic pores of an extracellular matrix composed of fibronectin, osteocalcin and collagen I. In addition, numerous microcrystals of apatite precipitated on the fibrillar matrix, producing a mineralized fibrillar network within the ceramic. CONCLUSION: This study demonstrates that human bone-marrow cells cultured on macroporous CaP ceramic do not lose their osteoblastic phenotype even after 21 days of culture, and that they can induce osteogenesis in a CaP ceramic in vitro. This type of new "hybrid material" appears promising for the future.

Bone Marrow Cells↗

PubMedDate not supplied

Coralline hydroxyapatite bone graft substitutes.

The authors present a review of the various bone grafts currently available with special attention to coral bone grafts. Several of the benefits of coralline hydroxyapatite bone graft substitutes, such as safety and biocompatibility, will be addressed in this article, part of an ongoing investigation of coral bone grafts used in triple arthrodesis procedures. To date, eight cases have been performed. In seven cases, granular chips were employed to pack the subtalar joint. The final case, presented in this article, represents a 26-year-old male who, 2 years previously, sustained a calcaneal fracture with resultant shortening along the lateral column. A coralline hydroxyapatite block was used at the calcaneocuboid joint to achieve distraction. Clinically, the patient is progressing well at 10 months postoperatively. Radiographically, one can still clearly appreciate the margins of the bone graft at 5 months.

Adult↗

PubMed2004

Growth and proliferation of human osteoblasts on different bone graft substitutes: an in vitro study.

The purpose of this study was to investigate the effect of different bone graft substitutes onto the growth and proliferation pattern of bone cells derived from human iliac cancellous bone. Five different bone graft materials were used to investigate the effect on the proliferation of osteoblasts in vitro: phytogene hydroxyapatite (Algipore), alpha-Tricalcium phosphate (Bio-Base), bovine hydroxyapatite (low temperature) (Bio-Oss), bovine hydroxyapatite (high temperature) (Osteograf), and bovine hydroxyapatite (high temperature) enhanced with p-15, synthetic peptide (PepGen p-15). The osteoblasts were derived from human iliac cancellous bone and seeded with the different bone substitutes. The cell proliferation and viability (WST-1), alkaline phosphatase as an early marker of osteoblast proliferation, was evaluated after 6 and 9 days. The cultures were examined for cell growth pattern and morphology by normal light and scanning electron microscopy. The human osteoblasts showed a different proliferation pattern according to the type of applied bone graft substitute. PepGen P-15 showed the highest proliferation and differentiation rate followed by Osteograf, Algipore, and Bio-base. Bio-Oss showed the lowest. These results were confirmed by electron microscopy and light microscopy evaluation in which similar growth pattern were observed. Distinct bone graft materials have different impact onto the proliferation pattern of human osteoblasts in vitro.

Adult↗

PubMed1995

Comparative study of the osteoinductive properties of bioceramic, coral and processed bone graft substitutes.

This study compared the osteoinductive properties of six different bone graft substitutes: Pyrost, natural coral, Callopat, Surgibone, demineralized Surgibone and demineralized rat bone. The materials were implanted heterotopically, in the abdominal musculature of rats, and the results evaluated histologically at 3 and 6 wk post-implantation. Surprisingly, the results showed that both the demineralized rat bone and demineralized Surgibone were less osteoinductive than might be believed from the literature. Mineralized grafts showed no sign of new bone formation and exhibited variable resorption patterns. A layer of what appeared as dense calcification was seen around the coral implant. The most intense inflammatory reactions were exhibited with the xenografts Surgibone and demineralized Surgibone, indicating persistent immune responses. Coral and Pyrost elicited no marked inflammatory response, and this was attributed to the negligible amounts of protein present in these materials.

Animals↗

PubMed1998

Proper design of clinical trials for the assessment of bone graft substitutes.

To assess the effectiveness and safety of engineered bone graft substitutes proper, clinical trials will need to be performed. Although the randomized placebo controlled prospective clinical trial is the gold standard, clinical trials of this design are difficult to perform in the surgical setting. At this writing, several clinical trials evaluating bone graft materials have been performed, and much was learned toward improving the design of future studies. This article reviews alternatives to the placebo controlled randomized clinical trials in the surgical setting. The importance of long term surveillance is emphasized.

Bone Substitutes↗