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PubMed2002

The use of an antibiotic-impregnated, osteoconductive, bioabsorbable bone substitute in the treatment of infected long bone defects: early results of a prospective trial.

OBJECTIVE: We sought to evaluate the use of a bioabsorbable, tobramycin-impregnated bone graft substitute (calcium sulfate alpha-hemihydrate pellets) in the treatment of patients with infected bony defects and nonunions. STUDY DESIGN/METHODS: Twenty-five patients (15 male and 10 female, mean age 43 years (range 27-69 years) requiring surgical debridement of culture-positive long bone infection (16 with associated nonunion) were entered into an ongoing consecutive, prospective clinical trial. Involved bones included the tibia ( 15), femur ( 6), ulna ( 3), and humerus ( 1). All defects were posttraumatic in origin, and each patient had had previous surgery at the involved site (mean 4.3 surgeries; range 1-8 surgeries). The duration of infection ranged from 4 months to 20 years (mean 43 months). According to the Cierny-Mader classification system, there was 1 stage I (medullary osteomyelitis), 6 stage III (localized osteomyelitis), and 18 stage IV (diffuse osteomyelitis) lesions. There were 4 normal (A) hosts and 21 locally and/or systemically compromised (B) hosts. Mean bone defect/void was 30.5 cm (range 3-192 cm ). RESULTS: Mean follow-up was 28 months (range 20-38 months). Radiographically, pellets were resorbed at a mean of 2.7 months postoperatively. Infection was eradicated in 23 of 25 patients (92%). Isolated bony defects healed in all nine patients without further treatment. Fourteen of 16 patients with nonunion achieved union, although nine required autogenous bone grafting. Union was achieved in five of seven nonunion patients treated with bone graft substitute in isolation. Complications included refracture (three), recurrence of infection (two), persistent nonunion (two), and superficial wound necrosis (one). Eight patients developed sterile draining sinuses that healed upon radiographic resorption of the pellets. CONCLUSIONS: In patients with posttraumatic osteomyelitis, the bone graft substitute was effective in eradicating bone infection in 23 of 25 patients. Isolated bony defects healed reliably (nine of nine) following addition of bone graft substitute alone. The role of the bone graft substitute in isolation in the treatment of nonunion is unclear at present.

Adult↗

PubMed2004

Alveolar bone regeneration for immediate implant placement using an injectable bone substitute: an experimental study in dogs.

BACKGROUND: The aim of the present study was to assess the efficacy of a ready-to-use injectable bone substitute for bone regeneration around dental implants placed into fresh extraction sockets. METHODS: Third and fourth mandibular premolars were extracted from three beagle dogs and the interradicular septa were surgically reduced to induce a mesial bone defect. Thereafter, titanium implants were immediately placed. On the left side of the jaw, mesial bone defects were filled with an injectable bone substitute (IBS), obtained by combining a polymer and biphasic calcium phosphate ceramic granules. The right defects were left unfilled as controls. After 3 months of healing, specimens were prepared for histological and histomorphometric evaluations. RESULTS: No post-surgical complications were observed during the healing period. In all experimental conditions, histological observations revealed a lamellar bone formation in contact with the implant. Histomorphometric analysis showed that IBS triggers a significant (P<0.05) increase in terms of the number of threads in contact with bone, bone-to-implant contact, and peri-implant bone density of approximately 8.6%, 11.0%, and 14.7%, respectively. In addition, no significant difference was observed when number of threads, bone-to-implant contact, and bone density in the filled defects were compared to the no-defect sites. CONCLUSION: It is concluded that an injectable bone substitute composed of a polymeric carrier and calcium phosphate significantly increases bone regeneration around immediately placed implants.

Alveolar Process↗

PubMed1999

[Modification of bacterial growth by alloplastic bone substitutes].

BACKGROUND: To determine the applicability of alloplastic materials as bone substitutes it is now standard procedure to test materials for possible toxic effects and to study their behavior in animal models and cell cultures. This is especially important with respect to middle ear implants that can be put at risk by recurrent infections and require additional testing in a bacterially contaminated environment. MATERIALS AND METHODS: In the present study ionomeric cement (V-O CEM), bioactive glass ceramic and hydroxyapatite were subjected to contamination with S. aureus, E. coli, Pr. mirabilis, Ps. aeruginosa and Enterococci using agar diffusion and microbial suspension tests and examined for their antibacterial activity. A special feature of V-O CEM that had to be considered was that it could be implanted in two physical states (as a viscous substance and a fully hardened material). RESULTS: The agar diffusion test showed that an antibacterial effect of freshly mixed V-O CEM was demonstrable for up to 60 min. In the microbial suspension test growth of E. coli was found to be promoted after 48-h incubation by V-O CEM set for 1 h. S. aureus exhibited a depressed growth, while Pseudomonas cultures demonstrated cell death after 48 h. V-O CEM set for 24 h and 7 days, respectively, exerted a similar though less pronounced effect. Using the microbial suspension test, a comparison was also made of the antibacterial activities of 24-h V-O CEM, bioactive glass ceramic and hydroxyapatite against cultures of S. aureus, Pseudomonas and E. coli. The inhibitory effect of hydroxyapatite on the growth of S. aureus was found to persist beyond the 48-h incubation period. There was slight growth of E. coli in the presence of bioactive glass ceramic after 48 h, whereas hydroxyapatite produced inhibition of microbial growth. V-O CEM inhibited the growth of Pseudomonas, unlike bioactive glass ceramic and hydroxyapatite, which transiently promoted bacterial growth. DISCUSSION AND CONCLUSIONS: Our findings showed that V-O CEM, bioactive glass ceramic and hydroxyapatite exhibited material-dependent bacterial colonization and thus resembled polymeric bone substitutes (susceptible to invasion by S. epidermidis) and metals (sensitive to S. aureus). In general, users of bone substitutes should conduct preclinical tests in order to obtain advance information on the properties of possible replacement material. Since there can be varying interactions between the materials studied and bacterial growth, material-specific effects on bacterial growth should be investigated. While it is recognized that in vitro studies are an inadequate simulation of the clinical situation, they still provide some insight into the likely behavior of a bone substitutes in human sites.

Bacteriological Techniques↗

PubMed2006

The monocortical critical size bone defect as an alternative experimental model in testing bone substitute materials.

BACKGROUND: Reproducibility and comparability are prerequisites in testing bone substitute materials in an animal study. Various animal test models are used. The standard in testing bone substitute materials is the so-called critical size defect (CSD) model described by Schmitz and Hollinger. In most studies a bicortical (full thickness defect) CSD is used. OBJECTIVE: In this study, monocortical defects (10 x 10 mm) in calvarias of adult pigs were created and compared to examine the spontaneous physiologic healing process and the required criteria for a CSD. STUDY DESIGN: Regeneration of defects, either filled using autogenous bone (group 1) or unfilled (group 2), was evaluated by means of microradiography and light microscopy after 2, 4, 12, 26, and 52 weeks. RESULTS: No complete osseous regeneration was found microradiographically and light microscopically in the control group at week 52 (nonmineralized area: 30% +/- 1.7%; mineralized area: 55% +/- 1.7%; bone marrow area: 15% +/- 1.7%). Defects treated with autogenous bone showed a 100% osseous defect filling after 26 weeks. CONCLUSION: The monocortical CSD fulfills the requirements for a CSD and represents a procedure which can be handled simply for investigations focusing on bone regeneration and testing of bone substitute materials.

Animals↗

PubMed2006

Bone repair using a new injectable self-crosslinkable bone substitute.

A new injectable and self-crosslinkable bone substitute (IBS2) was developed for filling bone defects. The IBS2 consisted of a chemically modified polymer solution mixed with biphasic calcium phosphate (BCP) ceramic particles. The polymer hydroxypropylmethyl cellulose was functionalized with silanol groups (Si-HPMC) and formed a viscous solution (3 wt %) in alkaline medium. With a decrease in pH, self-hardening occurred due to the formation of intermolecular -Si-O- bonds. During setting, BCP particles, 40 to 80 microm in diameter, were added to the polymer solution at a weight ratio of 50/50. The resulting injectable material was bilaterally implanted into critically sized bone defects at the distal femoral epiphyses of nine New Zealand White rabbits. The IBS2 filled the bone defects entirely and remained in place. After 8 weeks, bone had grown centripetally and progressed towards the center of the defects. Newly formed bone, ceramic, and nonmineralized tissue ratios were 24.6% +/- 5.6%, 21.6% +/- 5.8%, and 53.7% +/- 0.1%, respectively. Mineralized and mature bone was observed between and in contact with the BCP particles. The bone/ceramic apposition was 73.4% +/- 10.6%. The yield strength for the IBS2-filled defects was 16.4 +/- 7.2 MPa, significantly higher than for the host trabecular bone tissue (2.7 +/- 0.4 MPa). This study showed that BCP particles supported the bone healing process by osteoconduction while the Si-HPMC hydrogel created intergranular space for bone ingrowth. This new injectable and self-crosslinkable bone substitute could be used conveniently in orthopedic surgery for filling critical-size bone defects.

Animals↗

PubMed2001

Proliferation and differentiation rates of a human osteoblast-like cell line (SaOS-2) in contact with different bone substitute materials.

The aim of our study was to investigate the influence of four bone substitutes on the growth behavior of a human osteoblast-like cell line (SaOS-2) culture: pure alpha tricalcium phosphate (alpha-TCP = BIOBASE), a bioactive glass (bioglass), a neutralized glass-ceramic (GB9N), and solvent dehydrated bone. We established an in vitro cell culture model with three-dimensional scaffolds (cubes of 0.7 x 0.7 x 1.0 cm) of porous bone substitutes to investigate proliferation and differentiation rates of SaOS-2 cells. The cultures were analyzed for individual cell morphology after 5 days of growing using scanning electron microscopy. Fracture preparations of the cubes showed that cells could infiltrate the porous structures, but the cell shapes varied from individual round-shaped cells to wide spread cells and cell clusters, depending on the material. Also, the differentiation of the seeded cells was dissimilar after a 5-day incubation. The specific alkaline phosphatase (ALP) enzyme activity (ALP/DNA) measured in the supernatants of alpha-TCP-grown cells was nine times higher than the lowest activity, as observed by cells incubated on GB9N. Early (Collagen1, ALP) and late marker (osteocalcin, bone sialoprotein) of osteoblastic differentiation were proofed by reverse transcriptase-polymerase chain reaction analysis. Cells grown on bone substitutes and bioglass seem to be less differentiated than alpha-TCP-grown cells, because of noticeably less amounts of osteocalcin and bone sialoprotein. The cultivation on GB9N seems to dedifferentiate the cells, because even the ALP expression was reduced as well. Our results indicate that distinct bone substitutes influence proliferation and differentiation of osteoblastic cells in different manners. These results might influence the selection of an adequate bone substitute for clinical use as well, part from degradative and biomechanical properties.

Bone Substitutes↗

PubMed1999

Bone grafts and bone substitutes in hip and knee surgery.

Bone grafts and bone substitutes are an essential part of the armamentarium of orthopedic surgeons. This article presents the current knowledge about bone replacements and reviews the available sources, techniques, and indications of the various types of autograft, allograft, and synthetic agents that are used in contemporary hip and knee replacement surgery.

Arthroplasty, Replacement, Hip↗

PubMed2004

Long-term results with different bone substitutes used for sinus floor elevation.

One of the surgical procedures preceding implantation is elevation of the base of the maxillary sinus. Numerous bone substituting materials (grafts) may be used for this purpose, including autogenous bone, heterografts, xenogenous bone, and synthetic materials alone or in combination or mixed with growth factors and bone morphogenetic protein (BMP) preparations. A study of the frequencies of the failures (graft material resorption or implant loss) after sinus elevations with various graft materials or their combinations was conducted. In the 5-year period from 1996 through 2001, a follow-up investigation of 810 maxillary sinus augmentations was performed, in which the sinus elevations involved the use of autogenous bone, a calcium carbonate-coated polymer, hydroxylapatite of algal origin, calcium carbonate gel produced from coral or beta-tricalcium phosphate alone, autogenous bone mixed with these bone substitutes, or a combination of beta-tricalcium phosphate and platelet-rich plasma. The incidences of graft resorption and implant loss after the augmentations with various bone substitutes were recorded. Total resorption (disappearance) of the bone substitute material was observed in 2.7% of the cases. An essential difference was not experienced between the various bone substitutes from this aspect, with the exception of the gel-state calcium carbonate, where 40% of the grafts were resorbed. In total, 5.46% of the implants were lost; the differences between the various materials were not significant.

Absorbable Implants↗

PubMed2006

Use of a synthetic bone substitute to retard molariform tooth drift after maxillary tooth loss in ponies.

OBJECTIVE: To evaluate the effect of alveolar bone substitute on post-extraction drift of maxillary cheek teeth in ponies. STUDY DESIGN: In vivo longitudinal experimental study. ANIMALS: Five ponies (5-7 years) with a healthy dentition. METHODS: Both maxillary 4th premolar teeth (Triadan 08) were surgically removed. One alveolus was filled with a biocompatible non-resorbable bone substitute (Bioplant 24), whereas the other healed by second intention. A polyvinylsiloxane plug and spring wire isolated the bone substitute from the oral environment. Pathologic changes to dentition and adjacent soft tissue were recorded. Tooth drift was calculated after 1 and 2 years. RESULTS: At 1 month, bone substitute material was incorporated into healthy tissue. Tooth drift was observed but differed significantly between control and treated sides at 2 years (P<.01). For both techniques, tooth drift differed significantly between years 1 and 2 (P<.001). Total drift in control arcades for year 1 was 10.69+/-2.12 mm and for year 2 was 9.08+/-0.87 mm, whereas for bone substitute arcades it was 9.90+/-1.60 mm for year 1 and 5.60+/-1.78 mm for year 2. CONCLUSIONS: Partial tooth replacement therapy after maxillary P4 extraction provided good healing in the immediate post-surgical phase. Alveolar filling with bone substitute material significantly slowed post-extraction tooth drift but did not stop it completely. Clinical Relevance- Important changes occur in equine dentition after maxillary cheek teeth removal. Further longer term observations are needed to fully validate study findings.

Animals↗

PubMed1989

[The significance of Ilmaplant as a bone substitute with reference to prostaglandin biosynthesis in bones. An animal experiment-clinical study].

The paper pointed out the resorbable material Ilmaplant-R and the glass ceramic Ilmaplant-L which are used for bone substitution. X-ray, histomorphometric and total mineral contents study were carried out in the region of healing defects in the tibia of 60 male white wistar rats. The healing response of the two bioceramics was compared 12 weeks after implantation. The inductive properties of prostaglandins were discussed. The possibilities of clinical application of Ilmaplant-R were demonstrated on the basis of short-term results up to 12 months.

Animals↗

PubMed1997

Biocompatibility and osteoconductivity of the pyrost bone substitutes.

The purpose of this study was to re-evaluate the bone regeneration power and the in vitro biocompatibility of the Pyrost bone substitute. Twenty-four adult New Zealand White rabbits were used. Bony defect over both iliac crest and mid-diaphyseal portion of the ulna bone were created. Appropriate sized-block of Pyrost bone substitute were implanted. Four of the animals were killed at each postoperative month to evaluate its bone regeneration power by histologic study. The Pyrost bones were co-cultured with osteoblasts to evaluate its biocompatibility. The results showed that Pyrost bone substitute was quite stable and incorporated well with active bone regeneration. The Pyrost heal better at the iliac crest than at the ulnar defect. The Pyrost was compatible to the osteoblasts. Osteoblasts had successfully seeded and mitotically expanded on the porous surface of the Pyrost bone graft. The result showed that Pyrost bone obviously exerts an intense stimulus on osteo-regeneration in the presence of osteoblasts. We consider Pyrost to be an alternate to the conventional preserved allografts that is occasionally necessary.

Animals↗

PubMed2005

The sinus lift with phycogenic bone substitute. A histomorphometric study.

OBJECTIVES: The aim of this histomorphometric prospective study was to ascertain the efficacy of phycogenic bone substitute in an augmented sinus. The process of graft healing, bone remodeling, and biomaterial replacement was examined. MATERIAL AND METHODS: The phycogenic material (fluorohydroxyapatite) made from calcium-encrusted sea algae was used for the sinus lifts. Twenty-four procedures were carried out (one-stage and two-stage equally) and 45 titanium stepped-screw implants were placed. The patients were followed for 12-23 months. In intervals of 6, 9, 12, or 15 months after the sinus lift, 24 graft specimens were taken with a trephine bur. These specimens were examined histomorphometrically. RESULTS: The grafting material was gradually resorbed and replaced by newly formed bone. Between the sixth and 15th month after the sinus lift, the percentage of newly formed bone grew linearly (from 15.5+/-9.6% to 40.8+/-15.3%) and the percentage of bone substitute decreased linearly (from 34.5+/-8.6% to 13+/-9.6%). After 15 months, the density of trabeculae in grafted bone corresponded to cancellous bone of good quality; however, the bone substitute was not completely resorbed during this period. No significant difference between the quality of the newly formed bone in the cases of the one- and two-stage sinus lifts was found. CONCLUSION: Sinus lift carried out with phycogenic bone substitute was shown to be an effective method with limited invasiveness and a high survival rate of implants (97.8%).

Adolescent↗

PubMed1999

Nuclear magnetic resonance spectroscopy of bone substitutes.

Calcium phosphate bone replacement biomaterials are widely used in different applications. Structure, composition, and organization are, before implantation, analyzed with different methods. Among them, X-ray diffraction is a recognized test. As bioresorption produces more amorphous material, the process is observed and quantified via scanning electron microscopy. Comparatively high-resolution 31P solid-state nuclear magnetic resonance spectroscopy is able to analyze raw ceramics composition and to estimate osteoformation.

Animals↗

PubMed2003

[About remodelling in connection with two cases of bone substitution].

Numerous possibilities are available for the reconstruction of facial bone defects. The materials utilized to fill such defects must satisfy various requirements. One of the most important being that they must undergo transformation into autologous bone tissue in the process of remodelling. A report is given of the long-term results of augmentations performed with different bone-substitute materials in two patients. In one case, augmentation was carried out with beta-tricalcium phosphate following the removal of a fibromyxoma. In the second case, three large cystic lesions in the mandible of a patient with Gorlin-Goltz syndrome were filled with beta-tricalcium phosphate, with a mixture of beta-tricalcium phosphate and platelet concentrate, or with hydroxyapatite of algal origin respectively. The process of ossification was checked at 6-months intervals by means of clinical and radiological (orthopantomogramms and 2D and 3D computertomogramms) methods. One year after the intervention, the site of the augmentation was in all cases occupied by hard tissue of good quality. With the given imaging procedures, it was difficult to distinguish between the original bone and the region filled with bone-substitute material. The 3D computertomogramm images indicated that the contours and quality of the new bone corresponded to the physiological and anatomical conditions. The bone-substitute materials applied in these cases fully satisfied the demands of transformation into bone (remodelling).

Adolescent↗

PubMedDate not supplied

[Modern surgical treatment of aneurysmal bone cyst using a synthetic bone substitute (Ceraform, a calcium phosphate ceramic)].

Aneurysmal bone cyst is a benign pseudotumoral dystrophy of bone, presenting expansive, destructive, nonresolutive features and often recurrence. A "stand-by" therapeutically attitude, in a survey manner, based on some spontaneous regression of certain areas of the aneurysmal cyst, due to thrombosis and fibrosis, is rarely advocated. When tumoral lesions are located in long bones and the bone length must be preserved, the bioptic curettage, followed or not by auto-grafting or cortical/cancellous allografting to bridge defect, represents the treatment of choice. The inconveniences encountered in using auto- or allografts have raised a growing interest towards synthetic bone substitutes. The most used of them are phosphocalcic ceramics due to their basic properties regarding interaction between bone and the substitution material, especially macroporosity Lately, we started to use (as clinical application) a bone substitute based on synthetic biphasic macroporous ceramic (CERAFORM), covering a wide range of procedures: benign tumors and dystrophies, spinal or joint arthrodesis, periprosthetic fractures, revisions following failures of primary total hip replacements. We obtained promising results, suggesting that in a situation with limited bone defects, as in clinical case presentation, if there exist a good contact and strong mechanical fixation, CERAFORM represents a reliable option comparing to allograft.

Adolescent↗

PubMedDate not supplied

Bone regeneration in standardized bone defects with autografts or bone substitutes in combination with platelet concentrate: a histologic and histomorphometric study in the mandibles of minipigs.

PURPOSE: To evaluate the effect of the addition of platelet concentrate (PC) to autografts or bone substitutes on bone regeneration in standardized bone defects. MATERIALS AND METHODS: Three standardized bone defects were prepared in both mandibular angles of 12 adult minipigs. The defects were grafted with autograft, anorganic bovine bone, or synthetic beta-tricalcium phosphate (beta-TCP). PC was added to only 1 side. The animals were divided into 4 groups, which were sacrificed at 4 different time points (1, 2, 4, and 8 weeks) for histologic and histomorphometric analysis. The concentrations of platelets and growth factors were measured to identify correlation to the histologic and histomorphometric results. RESULTS: No correlation was found between platelet count in whole blood and platelet count in PC (r(p) = 0.36). Furthermore, no correlation could be demonstrated between the platelet count of the PC and the concentrations of PDGF-AB (r(p) = -0.27) and TGF-beta (r(p) = 0.34). There were no signs of a stimulating effect of PC on bone formation in combination with autografts or bone substitutes at any time point (P = .89). Addition of PC did not alter the pattern of graft degradation. DISCUSSION: The present study underlines the need for further investigation to identify the optimal concentrations of platelets and combinations of growth factors to achieve a predictable stimulatory effect on bone regeneration. One of the first steps to achieve this goal will be the development of a reliable method for the procurement of PC. CONCLUSION: PC had no impact on bone formation and graft degradation in standardized bone defects in the mandibles of minipigs.

Analysis of Variance↗

PubMed1995

Implantable bone substitute materials.

This article focuses on materials used as bone substitutes. The materials may be used as substitutes for autografts or, in some cases, along with autografts. Each material has unique properties that may be beneficial for specific applications. Some future developments in bone substitute materials are also discussed.

Bone Substitutes↗

PubMed1999

The use of an injectable, biodegradable calcium phosphate bone substitute for the prophylactic augmentation of osteoporotic vertebrae and the management of vertebral compression fractures.

STUDY DESIGN: A biomechanical study comparing two materials for augmentation of osteoporotic vertebral bodies and vertebral bodies after compression fracture. OBJECTIVES: To compare an injected, biodegradable calcium phosphate bone substitute with injected polymethylmethacrylate bone cement for strengthening osteoporotic vertebral bodies and improving the integrity of vertebral compression fractures. SUMMARY OF BACKGROUND DATA: Injection of polymethylmethacrylate bone cement into fractured vertebral bodies has been used clinically. However, there is concern about thermal damage to the neural elements during polymerization of the polymethylmethacrylate bone cement as well as its negative effects on bone remodeling. Biodegradable calcium phosphate bone substitutes have been studied for enhancement of fixation in fractured vertebrae. METHODS: Forty fresh osteoporotic thoracolumbar vertebrae were used for two separate parts of this study: 1) injection into osteoporotic vertebrae: intact control (n = 8), calcium phosphate (n = 8), and polymethylmethacrylate bone cement (n = 8) groups. Each specimen then was loaded in anterior compression until failure; 2) injection into postfractured vertebrae: calcium phosphate (n = 8) and polymethylmethacrylate bone cement (n = 8) groups. Before and after injection, the specimens were radiographed in the lateral projection to determine changes in vertebral body height and then loaded to failure in anterior bending. RESULTS: For intact osteoporotic vertebrae, the average fracture strength was 527 +/- 43 N (stiffness, 84 +/- 11 N/mm), 1063 +/- 127 N (stiffness, 157 +/- 21 N/mm) for the group injected with calcium phosphate, and 1036 +/- 100 N (stiffness, 156 +/- 8 N/mm) for the group injected with polymethylmethacrylate bone cement. The fracture strength and stiffness in the calcium phosphate bone substitute group and those in the polymethylmethacrylate bone cement group were similar and significantly stronger than those in intact control group (P < 0.05). For the compression fracture study, anterior vertebral height was increased 58.5 +/- 4.6% in the group injected with calcium phosphate and 58.0 +/- 6.5% in the group injected with polymethylmethacrylate bone cement as compared with preinjection fracture heights. No significant difference between the two groups was found in anterior vertebral height, fracture strength, or stiffness. CONCLUSION: This study demonstrated that the injection of a biodegradable calcium phosphate bone substitute to strengthen osteoporotic vertebral bodies or improve vertebral compression fractures might provide an alternative to the use of polymethylmethacrylate bone cement.

Absorbable Implants↗