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PubMed1994

Experimental model of posterolateral spinal arthrodesis in sheep. Part 2. Application of the model: evaluation of vertebral fusion obtained with coral (Porites) or with a biphasic ceramic (Triosite).

OBJECTIVES: The authors evaluated two bone substitutes in a posterolateral spinal arthrodesis (PSA) model in sheep: coral porites (99% calcium carbonate, Biocoral, Inoteb, France) and a biphasic ceramic (BCP) (65% hydroxyapatite and 35% B tricalcium phosphate, Triosite, Zimmer International). SUMMARY OF BACKGROUND DATA: Bone substitutes would be of great interest for PSA. Previous trials began with two kinds of biomaterials: natural coralline calcium carbonate, and phosphate calcium ceramic. METHODS: A lumbar PSA was performed in 11 sheep (coral group) and in 9 sheep (BCP group). Sacrifice and biomechanical tests were performed after 1 year. RESULTS: A large decrease of flexibility in all directions was obtained with both coral PSA and BCP PSA similarly to autologous graft. No nonfusion case was observed. CONCLUSION: In conditions close to the human surgery, a PSA can be obtained using either coral porites or BCP as bone substitutes.

Animals↗
PubMed2002

Anterior cervical fusion with carbon fiber cage containing coralline hydroxyapatite: preliminary observations in 45 consecutive cases of soft-disc herniation.

OBJECT: The purposes of bone substitutes for anterior cervical fusion (ACF) are immediate biomechanical support and osteointegration of the graft. The authors report their preliminary results in performing ACF in which carbon fiber cages (CFCs) containing coralline hydroxyapatite (HA) are used as bone substitute. METHODS: During a 24-month period, anterior microsurgical discectomy was performed in 45 consecutive patients for soft-disc cervical herniation. In all cases ACF was performed using a CFC containing a core of granulated coralline HA. Fifty-seven CFCs were implanted in 33 single-level and 12 two-level procedures. The mean operative time was 83 minutes for one-level and 97 minutes for two-level procedures. The mean hospital stay was 1.51 days, and there were no permanent complications. At a mean follow up of 22.3 months, the pain had decreased or disappeared in all patients, and the patients' satisfaction rate was very high. Good results were also obtained in patients who smoked cigarettes. Patients underwent radiographic evaluation at Day 1, and 1, 3, 6, and 12 months postoperatively. Implant-related complications were not observed and revision surgeries were not performed. Twelve-month cervical x-ray films demonstrated complete fusion in all cases, without evidence of breakage, collapse, pseudarthrosis, subsidence, angular deformity, or protrusion. Signs of pathological absorption and necrosis were not found in contiguous vertebral bodies, and inflammatory reactions were never seen around cages. CONCLUSIONS: These preliminary results suggest that implants composed of CFC containing granulated coralline HA are promising bone substitutes to be used in ACF, with a good rate of incorporation and no significant complications.

Adult↗
PubMed2005

Comparison of Healos/bone marrow to INFUSE(rhBMP-2/ACS) with a collagen-ceramic sponge bulking agent as graft substitutes for lumbar spine fusion.

STUDY DESIGN: A rabbit lumbar intertransverse process arthrodesis model was used to evaluate the efficacy of two different bone substitute materials: 1) collagen-hydroxyapatite sponge (Healos bone void filler) combined with heparinized bone marrow; and 2) recombinant human bone morphogenetic protein-2 delivered in a collagen sponge (INFUSE Bone Graft) wrapped around an additional collagen-ceramic sponge (Mastergraft Matrix) as a "bulking agent." OBJECTIVES: To compare the relative efficacy of two different bone graft substitutes to achieve posterolateral lumbar spine fusion in rabbits. SUMMARY OF BACKGROUND DATA: Autogenous bone graft is considered the gold standard graft material for spine fusion. Complications with its use, however, may occur in as many as 30% of patients. A variety of bone substitutes have been used for spine fusion, but there are few direct comparison experiments to determine the relative efficacy of any two alternatives. METHODS: Adult New Zealand white rabbits (n = 24) were divided into two groups and underwent bilateral posterolateral intertransverse process spine arthrodesis at L5-L6. The fusions were augmented by different bone substitute materials as follows: Group 1 (n = 12) received 3 mL of collagen-hydroxyapatite sponge (Healos bone void filler) (10 x 30 x 5 mm, two per side) with 3.0 mL of heparinized bone marrow on each side of the spine. (ratio 1:1); Group 2 (n = 12) received 1.5 mL of rhBMP-2 (0.43 mg/mL solution) on a Type 1 collagen sponge (INFUSE Bone Graft) wrapped around an additional 1.5 mL collagen-ceramic (15%HA/85%TCP) sponge (Mastergraft Matrix) as a bulking agent to provide 3 mL of graft on each side of the spine. Bone marrow was aspirated from posterior iliac crest, and 1 mL of bone marrow was sent to count number of nucleated cells. The rabbits were killed after 8 weeks; the spines were evaluated by manual palpation, radiographs (plain radiograph and CT scan), tensile mechanical testing, and nondecalcified histology. RESULTS: The bone marrow had average of total nucleated cell count 9 x 10 cells. All rabbits (100%) in Group 2 (INFUSE/Mastergraft Matrix) achieved solid spinal fusions by manual palpation and radiographs, whereas solid spinal fusion was not achieved by manual palpation and radiographs in any of the rabbits treated with Healos combined with heparinized bone marrow (Group 1). The plain radiograph and CT scans of Group 1 showed some minimal new bone formation near the transverse processes, but none of these rabbits formed a continuous fusion mass. In contrast, all of plain radiographs and CT scans in Group 2 showed continuous fusion mass and complete graft incorporation between transverse processes bilaterally. Biomechanically, the relative strength and relative stiffness values of L5-L6 (fusion segment) in Group 2 were statistically significant greater than L5-L6 in Group 1 (P < 0.001). Histologic sections confirmed the palpation and radiographic results. CONCLUSION: From the manual palpation, radiographic and biomechanical assessment of fusion, the results in this study showed that INFUSE (rhBMP-2/collagen sponge) consistently produced spine fusion when wrapped around a collagen-ceramic sponge bulking agent (Mastergraft Matrix). Meanwhile, Healos was ineffective as a bone graft material when combined with heparinized autogenous bone marrow.

Animals↗
PubMed1999

Sinus floor augmentation with simultaneous placement of dental implants using a combination of deproteinized bone xenografts and recombinant human osteogenic protein-1. A histometric study in miniature pigs.

Maxillary sinus floor augmentation with autogenous bone has become a widely accepted procedure in implant dentistry. The use of osteoconductive bone substitutes in this indication is controversial, since their use can lead to a prolonged healing time, inhomogenous ossification, foreign body reaction, migration of particles and low bone-implant contact (BIC). The purpose of this study was to examine whether the combination of an osteoinductive protein (recombinant human osteogenic protein-1 (rhOP-1 = bone morphogenetic protein-7) with natural bovine bone mineral (BioOss) would improve ossification and the bone-implant contact (BIC) in a sinus floor augmentation with simultaneous placement of implants. In this study, the maxillary sinus floors in 5 miniature pigs were augmented with 3 ml BioOss containing 420 micrograms rhOP-1 on the test side and 3 ml BioOss alone on the control side. At the time of augmentation a titanium implant (ITI) was inserted from a laterocaudal direction. After 6 months of healing the sites of augmentation were removed and examined in non-decalcified sections by microradiography, fluorescence microscopy of sequentially labelled specimens and by histometry. On both sides, significant amounts of newly-formed bone were observed. However, on the test sites, the percentage of BIC in the augmented area was 80.0% versus 38.6% on control sites. It can be concluded that the application of bone morphogenetic proteins caused a more rapid and enhanced osseointegration of simultaneously placed implants when compared to the bone substitute alone. Therefore recombinant human osteogenic protein-1 delivered by natural bone mineral has the potential to become a clinical alternative for autogenous bone grafts in sinus floor augmentation.

Animals↗
PubMed1995

In vivo evaluation of demineralized bone matrix as a bone graft substitute for posterior spinal fusion.

STUDY DESIGN: Posterior lumbar spinal fusion segments were evaluated in 9 adult mongrel dogs 6, 12, and 26 weeks after implantation. Four sites on each animal received implants consisting of demineralized bone matrix alone, demineralized bone matrix with allograft bone, allograft bone alone, and autograft bone. Each unilateral fusion spanned one motion segment with one intervening vertebral level left undisturbed using T13-L7. The fusions were evaluated radiographically, mechanically, and histologically. OBJECTIVE: The purpose of this study was to determine the efficacy of demineralized bone matrix as a bone graft substitute for stable posterior spinal fusion. SUMMARY OF BACKGROUND DATA: Posterior spinal fusion is a procedure commonly performed for spinal stabilization. Increasing the incidence and speed of stable spinal fusion is a primary goal in spinal surgery. Concerns have developed regarding the graft material used to induce bone healing at the fusion site. The advent of osteoinductive materials, such as demineralized bone matrix, may eliminate the need to harvest autograft bone and may circumvent the immunologic response and lower osteogenic potential associated with allograft bone. METHODS: The quality of fusion and new bone formation was evaluated radiographically using plain films, computed tomography, and magnetic resonance imaging. After the dogs were killed, each fusion segment was evaluated mechanically in torsion to determine stiffness and histologically to determine qualitative parameters of new bone formation and remodeling. RESULTS: Radiographic studies showed that autograft bone sites achieved stable fusion by 26 weeks after surgery. Conversely, the demineralized bone matrix alone and with allograft bone demonstrated some new bone formation at 6 and 12 weeks, but did not achieve fusion by 26 weeks. The fusion sites of allograft bone alone showed minimal new bone formation at all time periods. Mechanically, the autograft fusion sites demonstrated torsional stability that was significantly greater than that of all other fusion sites at all time periods. The remaining fusion sites showed equivalent torsional stiffness at all time periods. Histologic analysis confirmed the radiographic and mechanical findings. CONCLUSIONS: The results indicate that demineralized bone matrix alone or with allograft bone is ineffective in achieving stable posterior spinal fusions.

Animals↗
PubMed1988

Porous hydroxyapatite as a bone graft substitute in maxillary augmentation. An histometric study.

A porous HA matrix, which is available for clinical use, was compared with split rib autografts after maxillary contour augmentation in 17 dogs. Specimens were retrieved at 3, 6, 12, 24 and 48 months and undecalcified sections were prepared for microscopy and histometry. The implant and graft cross sectional areas did not change with time, although mechanical trauma caused early changes in implant area in some specimens. In all implants, union with the maxillary cortex occurred along with substantial bone ingrowth. An area under the periosteum contained soft tissue ingrowth. In all grafts, except one, union also occurred. However, bone ingrowth into the cancellous spaces was not apparent, or minimal. The implant specimens were composed of 34.7% HA matrix, 23.9% bone and 41.3% soft tissue. The bone ingrowth remained permanent for the study duration. A 6.5% decrease in HA matrix occurred between the 24 and 48 month time intervals, suggesting the presence of microporous surface resorption. The graft specimens were composed of 55.8% bone and 44.2% non-mineralized tissue, without change over time. The similarity in mineralized tissue composition of the implants (58.6%) and grafts (55.8%) supported the thesis that a porous HA matrix can function as a bone graft substitute.

Animals↗
PubMed2003

Assessment of the value of anorganic bone additives in sinus floor augmentation: a review of clinical reports.

In order to objectively assess the value of anorganic bone additives in sinus floor augmentation, a review of the English literature till May 2002 was carried out. The studies or parts of studies had to include at the least two patients, with a follow-up of at least 3 months, whilst histomorphometric data ought to be available of biopsies taken from the core of the graft. Only 12 studies fulfilled these criteria. Firm conclusions could not be drawn because there were substantial differences in histomorphometric techniques, healing periods and ratio autogenous bone anorganic additives, but it seemed that autogenous bone without anorganic additives resulted in the highest amount of bone after a 4-6 months healing period, while hydroxyapatite and bovine bone mineral, used as a bone substitute, gave the lowest amount of bone. No correlation between bone volume and time of graft healing could be found. The consequences, however, for implant placement and survival are at present, not fully understood. A plea is made for systematic prospective clinical and experimental studies to assess the various bone additives and ratios of autogenous bone to bone additives in composite grafts analysed with an adequate histomorphometric technique. Part of this study was presented at the 15th ICOMS, Durban, South Africa, 19-24 May 2001.

Alveolar Ridge Augmentation↗
PubMed2001

Efficacy of porous bovine bone mineral in various types of osseous deficiencies: clinical observations and literature review.

Recent developments in osseous regenerative techniques have increased the demand for bone-substitute grafting materials. Porous deproteinized bovine bone mineral (PBBM), a biocompatible xenograft, has been used in different osseous deficiencies prior to or in conjunction with the placement of titanium implants. The different PBBM applications in fresh extraction sites, anatomic defects, and subantral floor elevation techniques are described. The use of an occlusive barrier membrane to regenerate bone via guided tissue regeneration principles was determined for each patient by clinical parameters. PBBM was well amalgamated and incorporated with the augmented hard tissue, but the transition between preexisting bone and the newly regenerated bone-like tissue was distinguishable by clinical examination even after 12 months. Grafted material was also identified using follow-up radiographs. In the presented cases, PBBM showed clinically satisfactory results as a biocompatible filler in bone augmentation procedures.

Adult↗
PubMed2007

Biodegradable polyurethane cancellous bone graft substitutes in the treatment of iliac crest defects.

Porous scaffolds were produced from newly designed biodegradable, segmented aliphatic polyurethanes of various chemical compositions and hydrophilic-to-hydrophobic segment ratios. The scaffolds were implanted into monocortical defects in the iliac crest of healthy sheep for 6 months. The resected cortex was not repositioned. The ilium defects, which were not implanted with polyurethane scaffolds, were used as controls. In none of the control defects was there bone regeneration at the time of euthanasia. The defects implanted with porous scaffolds from polyurethanes were healed to varying extents with cancellous bone. The structure of the regenerated cancellous bone was radiographically denser than the structure of native bone. New bone that was formed in the scaffolds with a higher amount of hydrophilic component contained more calcium phosphate deposit than the bone formed in the scaffolds with a lower amount of the hydrophilic component. There was no new cortex formed over the defect, but a thin layer of soft tissue covered the newly formed cancellous bone.

Animals↗
PubMed2001

Dose measurements in inhomogeneous bone/tissue and lung/tissue phantoms for angiography using synchrotron radiation.

For angiography using synchrotron radiation we measured the absorbed dose distribution in inhomogeneous phantoms with thin LiF:Mg, Cu, P, LiF:Mg, Ti thermoluminescent dosimeters (TLDs) in tissue and lung substitutes, and with Mg2SiO4:Tb TLDs in bone substitute for 33.32 keV monoenergetic photons from synchrotron radiation. The energy responses of the TLDs were measured in air for 10-40 keV monoenergetic photons. The values at 30 keV became smaller by 30% for LiF:Mg, Cu, P and larger by 22% for Mg2SiO4:Tb than the ratio of the mass energy absorption coefficients of the TLDs to that of air. These values were used to modify the calculated response of the TLDs in each phantom material. The absorbed dose distribution obtained was compared with that calculated using the Monte Carlo transport code EGS4 expanded to a low-energy region, and their agreement was confirmed taking linear polarization into account. In the bone substitute the dose increased by a factor of 3.9, while behind the bone the dose decreased drastically because of photon attenuation. In the lung substitute a slight dose difference from that in soft tissue was observed because of its different density. The LiF:Mg, Cu, P TLDs exhibited a better energy response, higher sensitivity and wider linear regions than did the other tissue-equivalent TLDs in the low-energy region.

Bone and Bones↗
PubMed2003

Status of Bone Allografting in Japan - Nation-Wide Survey of Bone Grafting Performed from 1995 through 1999.

We report the status of bone allografting in Japan on the basis of the information obtained through questionnaires performed by the Japanese Orthopaedic Association (JOA). JOA performed a nation-wide survey in 2000, in order to clarify the current status of musculoskeletal tissue grafting in the orthopaedic practices in Japan. Conducted period was for 5 years from 1995 to 1999. As the results of this survey, it had been clarified that 92,984 bone graftings, which included autografts, allografts and synthetic bone substitutes, were performed during conducted 5 years. While the allografts were used only in 3,212 cases (3%), autograftings were performed in 64,193 cases (69%), synthetic bone substitutes were used in 25,576 cases (28%) in this series. The proportion of the number of operations for use bone substitutes increased every year, whereas that autografting decreased. The proportion of the number of allografting remained almost unaltered. Of the 706 institutions which answered to have experiences of tissue grafting, only 193 (27%) performed allograft.Since Kitasato University Hospital Bone Bank was developed in 1971, we have applied to clinical while doing basic research for preserved bone allograft. When extensive bone graft is required, allograft is very useful. In Japan, however, allograft is not performed widely. The foundation of regional bone banks is expected to resolve this problem. Since excision of bone preparations from cadaver donors is not common, bone allografts are not supplied sufficiently at present. It is needed to develop a network connecting bone banks in Japan. The enlightenment activities to the ordinary people and medical institutions will also be required.

Journal Article↗
PubMed2002

Adjunctive use of ultraporous beta-tricalcium phosphate bone void filler in spinal arthrodesis.

Spinal fusion is one of the most common clinical indications for bone grafting. However, synthetic bone substitutes are needed to ameliorate limited availability, donor site morbidity, and potential disease transmission concerns associated with autograft and allograft. One new synthetic bone substitute, Vitoss (Orthovita, Malvern, Pa), is an ultraporous formulation of beta-tricalcium phosphate (beta-TCP). This study examines 50 patients who received ultraporous beta-TCP bone void filler as an adjunct to autogenous bone graft while undergoing spinal fusion procedures. All patients underwent decompressive laminectomy with bilateral posterolateral intertransverse fusion (PLITF) using bone graft mixed with ultraporous beta-TCP, with and without instrumentation. Some patients also underwent posterior lumbar interbody fusion (PLIF) using cages and bone graft. Thirty-two patients were studied for at least 5-7 months postoperatively. Of these patients, 100% demonstrated good consolidation on follow-up radiographs. The use of iliac crest bone graft (ICBG) was avoided entirely in 7 (14%) of the 50 patients, and 30% less ICBG volume was required on average in others. Only 3 patients (7%) had donor site-associated pain. Controlled studies are being conducted to support the clinical impression that ultraporous beta-TCP used as a bone void filler in spinal arthrodesis facilitates bone healing at both the spinal and donor operative sites, and contributes to less overall morbidity.

Adult↗
PubMed1997

Animal experimentation with tooth derived calcium hydroxyapatite based composites as bone-graft substitute biomaterials.

Calcium Hydroxyapatite (HA) has now been clinically accepted as one of the most important alloplastic bonegraft substitute in the management of oral surgical procedures including periodontal bony defects. HA can be synthetically prepared or derived from natural sources. Among the natural sources bovine bone is common but human source is also used. Of late Calcium Hydroxyapatite has been derived from extracted human tooth source. The present study involves the experiments using different varieties of HA in conjunction with chitosan, a binder, to know it's unique biological behaviour of bone bonding. The experiment was designed using 12(Twelve) New Zealand white rabbits on transcortical drilled hole tibial model and the observation was made under optical and scanning electron microscope. Result showed the osteoconductive and bioactive nature of tooth derived HA and biocompatibility of chitosan. The clinical problem of handling the particulate form of HA can be overcome by using chitosan which when mix with HA can stabilize the particle in surgical sites. This has tremendous clinical applications in dental regenerative surgery.

Animals↗
PubMed1987

Hydroxyapatite and tricalcium phosphate bone graft substitutes.

Autografts have consistently outperformed calcium phosphate implants in most experimental models and clinical applications. However, human trials in metaphyseal defects demonstrate comparable results with autograft, hydroxyapatite, and TCP. Diaphyseal fractures and segmental defects represent more challenging problems, with less predictable results achieved with the synthetic bone graft substitutes. Improvements in the pore configuration, mechanical properties, and osteoinductive capacity of these implants should widen their future clinical application.

Adolescent↗
PubMed2005

[Stability of grafts and implants after bone grafting of the maxillary sinus. Retrospective analysis of 44 patients].

OBJECTIVES: We assessed the reliability of maxillary bone grafting and implant stability, comparing our results with reports in the literature. MATERIAL AND METHODS: This retrospective series included 44 patients who underwent maxillary sinus bone grafting between 1998 and 2002. An analogous graft was used for 31 patients and a combination autologous-bone substitute graft for 13. One hundred twelve dental implants were positioned at the grafting site (2.5 implants per graft). We assessed recipient site morbidity, bone graft integration and stability, and stability of the implants. RESULTS: Bone grafting was successful in 97.8% of patients. There was one failure. Two of the 112 implants failed. DISCUSSION: Our results are comparable with those in the literature. This study demonstrated the reliability of maxillary bone grafting with equivalent results using autologous bone and combination autologous bone-bone substitute.

Adult↗
PubMed2004

Effect of GBR and fixture installation on gingiva and bone levels at adjacent teeth.

Guided bone regeneration (GBR) is frequently used in oral implantology. It is unclear to what extent GBR affects the periodontium of adjacent teeth. Therefore, the present study quantifies changes in the proximal gingiva and bone levels at these teeth in 30 patients. Staged surgery involved a standard GBR treatment, randomly using resorbable membranes with a bone substitute or non-resorbable membranes with or without a bone substitute, followed by fixture installation at 6 months and abutment connection a further 6 months later. The data were sampled at each surgery and analysed using MANOVA. Twelve months after GBR, there was on average a small but statistically significant amount of proximal gingival recession (0.75 mm) and bone resorption (0.34 mm) observed, of which 50% was the result of GBR surgery. No significant differences were found between the different GBR treatment modalities. It is concluded that GBR treatment may have a small negative effect on the levels of the free gingival margin and alveolar bone at adjacent teeth, which is in most patients not clinically relevant.

Absorbable Implants↗
PubMed2005

Dental implant therapy in the treatment of an oroantral communication after exodontia.

A new technique in which a dental implant was the ultimate therapy for the treatment of an oroantral communication (OAC) that was created subsequent to the extraction of a maxillary first molar is described. A search of the English-speaking literature has not revealed implant therapy as part of documented modalities for the treatment of an OAC created following dental extraction. The OAC was closed by a sandwich technique that uses two resorbable membrane materials (Bio-Gide, Osteohealth, Shirley, NY) that surround a bone substitute (Bio-Oss, Osteohealth). This procedure, together with additional onlay grafting with the same bone substitute, was used also to regenerate subantral bone to enable the subsequent placement of an endosseous implant after 12 months. An 8-month postoperative radiograph showed creation of a new maxillary sinus bony floor and subantral bone of good quality, and height that can permit the placement of an endosseous dental implant.

Adult↗