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PubMed2004

[Biphasic ceramic wedge and plate fixation with locked adjustable screws for open wedge tibial osteotomy].

PURPOSE OF THE STUDY: The aim of this radiological study was to evaluate the use of a biphasic ceramic wedge combined with plate fixation with locked adjustable screws for open wedge tibial osteotomy. MATERIAL AND METHODS: Twenty-six consecutive patients (27 knees) underwent surgery between December 1999 and March 2002 to establish a normal lower-limb axis. The series included 6 women and 20 men, mean age 50 years (16 right knees and 11 left knees). Partial weight-bearing with crutches was allowed on day 1. A standard radiological assessment was performed on day 1, 90, and 360 (plain AP and lateral stance films of the knee). A pangonogram was performed before surgery and at day 360. Presence of a lateral metaphyseal space, development of peripheral cortical bridges, and osteointegration of the bone substitute-bone interface were evaluated used to assess bone healing. The medial tibial angle between the line tangent to the tibial plateau and the anatomic axis of the tibia (beta) was evaluated to assess preservation of postoperative correction. The HKA angle was determined. RESULTS: Three patients were lost to follow-up and 23 patients (24 knees) were retained for analysis. At last follow-up, presence of peripheral cortical bridges and complete filling of the lateral metaphyseal space demonstrated bone healing in all patients. Good quality osteointegration was achieved since 21 knees did not present an interface between the bone substitute and native bone (homogeneous transition zone). The beta angle was unchanged for 23 knees. A normal axis was observed in patients (16 knees) postoperatively. DISCUSSION: Use of a biphasic ceramic wedge in combination with plate fixation with locked adjustable screws is a reliable option for open wedge tibial osteotomy. The bone substitute fills the gap well. Tolerance and integration are optimal. Bone healing is achieved. Plate fixation with protected weight bearing appears to be a solid assembly, maintaining these corrections.

Adult↗

PubMed2001

Histology of human alveolar bone regeneration with a porous tricalcium phosphate. A report of two cases.

Porous beta-phase tricalcium phosphate particles (pTCP) (Cerasorb) were used in two patients to restore or augment alveolar bone prior to the placement of dental implants. In one patient, pTCP was used to fill a large alveolar defect in the posterior mandible after the removal of a residual cyst, and in another patient to augment the sinus floor. Biopsies were taken at the time of implant placement, 9.5 and 8 months after grafting, respectively, and processed for hard tissue histology. Goldner-stained histological sections showed considerable replacement of the bone substitute by bone and bone marrow. In the 9.5 months biopsy of the mandible, 34% of the biopsy consisted of mineralised bone tissue and 29% of remaining pTCP, while the biopsy at 8 months after sinus floor augmentation consisted of 20% mineralised bone and 44% remaining pTCP. Bone and osteoid were lying in close contact with the remaining pTCP and were also seen within the micropores of the grafted particles. Tartrate resistant-acid phosphatase (TRAP) multinuclear cells, presumably osteoclasts, were found surrounding, within and in close contact with the pTCP particles, suggesting active resorption of the bone substitute. Remodelling of immature woven bone into mature lamellar bone was also found. No histological signs of inflammation were detected. The limited data presented from these two cases suggest that this graft material, possibly by virtue of its porosity and chemical nature, may be a suitable bone substitute that can biodegrade and be replaced by new mineralising bone tissue.

Absorbable Implants↗

PubMed1992

Demineralized bone matrix polydioxanone composite as a substitute for bone graft: a comparative study in rats.

Demineralized bone matrix (DBM) has been successfully used as a substitute for bone grafting. Autogenous bone grafts (ABG) may cause donor site morbidity and undergo significant resorption. DBM may overcome these problems but is mechanically unstable when originally placed. We explored using a slowly resorbable template, polydioxanone (PDS), in combination with DBM and compared it to ABG in a rat 9 x 9 mm cranial defect model. After both 1 and 3 months, histologically and biochemically well-formed bone was present in ABG/PDS and DBM/PDS-treated defects, but not in control defects (PDS alone). Mechanical push-out tests using a servohydraulic testing frame were conducted. Maximum load before failure of DBM/PDS increased from 65% at 1 month to 100% of that of intact skull at 3 months. In contrast, ABG/PDS was 50% as strong as DBM/PDS and not significantly stronger than PDS alone. ABG/DBM did not significantly increase in strength from 1 to 3 months. We conclude that DBM/PDS is better than ABG/PDS in treating cranial defects in the rat model, and that an absorbable osteoinductive bone substitute with superior mechanical advantage is possible without the disadvantages of ABG.

Animals↗

PubMed2004

Treatment of benign bone lesions with an injectable calcium sulfate-based bone graft substitute.

The treatment of benign bone lesions can be challenging due to the limited quantity of autogenous graft available for harvest and grafting of the defect. The use of an injectable calcium bone graft substitute, Minimally-Invasive Injectable Graft (MIIG) (Wright Medical Technology, Inc, Arlington, Tenn), material for treatment of these bone lesions is advantageous. Calcium sulfate has a long-standing history in the treatment of bone voids secondary to trauma, infection, or neoplastic processes. Minimally-Invasive Injectable Graft injectable calcium sulfate graft may be injected into surgically created osseous defects or bone defects secondary to traumatic injury. After hardening, the paste acts as a temporary intraosseous support through which internal fixation may be placed. Fifteen patients with benign space-occupying lesions were treated with curettage and grafting with an injectable, surgical-grade, calcium sulfate bone graft substitute. Bone healing was assessed postoperatively and defined as resorption of the bone graft substitute material and replacement with new bone formation. The grafted defects in 14 of the 15 patients showed complete incorporation of the graft material at an average of 8 weeks. One patient required incision and drainage for a deep infection 5 weeks postoperatively. The average follow-up was 6 months (range: 3-15 months), and Musculoskeletal Tumor Society functional outcome scores averaged 83%. This injectable, minimally invasive graft material is easy to use, provides a temporary structural support when grafting bone defects, and results in predictable rapid bone healing.

Adolescent↗

PubMed1994

Experimental study on demineralized bone matrix (DBM) and coral as bone graft substitutes in maxillofacial surgery.

Three different bone substitutes were implanted in a standardized nasal bone defect in 30 Wistar rats. The results were assessed at 2 months by macroscopic examination, contact radiography, and histologic analysis. Demineralized osseous implants sterilized by ethylene oxide induced bone formation in 90% of the the cases, as no heat-treated graft showed any bone formation. Coralline grafts were osteointegrated in 50% of the cases, but osteoconduction was not sufficient to achieve complete bone repair. This study implies that ethylene oxide sterilization does not impair biologic properties of demineralized grafts, but further studies on more evolved animal species are necessary before human implantation.

Animals↗

PubMedDate not supplied

Bone graft substitutes: past, present, future.

Bone grafts are necessary to provide support, fill voids, and enhance biologic repair of skeletal defects. They are used by orthopaedic surgeons, neurosurgeons, craniofacial surgeons, and periodontists. Bone harvested from donor sites is the gold standard for this procedure. It is well documented that there are limitations and complications from the use of autograft, including the limited quantity and associated chronic donor site pain. Despite the increase in the number of procedures that require bone grafts, there has not been a single ideal bone graft substitute Scientists, surgeons, and medical companies, thus, have a tremendous responsibility to develop biologic alternatives that will enhance the functional capabilities of the bone graft substitute, and potentially reduce or eliminate the need for autograft. This article is an attempt to review the past and existing bone graft substitutes, and future directions of research. The historical data was extracted after thorough review of the literature. The data for the current concepts and future directions was compiled from the Internet, and from direct correspondence with medical companies. Since many products are undergoing clinical trials, and are yet not commercially available, their data cannot be found in literature. The main purpose of this article is to give the reader an idea about the existing market products and products likely to be available in near future.

Bone Diseases↗

PubMed1988

Hydroxylapatite as a bone graft substitute in orthognathic surgery: histologic and histometric findings.

The use of porous hydroxylapatite (HA) as a substitute for bone in grafting associated with orthognathic surgical procedures was studied histologically and histometrically. The surgical procedures included maxillary downgrafting, advancement, setback, superior repositioning with expansion, and mandibular advancement and chin augmentation. Seventeen biopsies were obtained from nine patients after successful healing from 4.7 to 16.4 months postoperatively. Anatomic sites of the biopsies included maxillary wall, interdental region, palatal midline, chin, and mandible. In addition, nine implants representing six planned and three unplanned exposures were retrieved from nine patients. One biopsy from a successful implant was decalcified and thin-sectioned to provide better cell detail of the antral lining of the implant. The remaining biopsies were sectioned undecalcified to permit backscattered electron imaging with a scanning electron microscope. Each of the 17 biopsy specimens contained bone ingrowth. The decalcified specimen showed an intact submucosa with loss of the mucosal epithelium due to prolonged acid exposure. The biopsies were composed of 48.5% HA matrix, 18.0% bone ingrowth, and 33.5% soft tissue or vascular space. The HA matrix surface area averaged 9.4 mm2/mm3 with 62.1% of the surface covered by appositional bone ingrowth. The nine exposed implants contained connective tissue ingrowth only at their margins, with little or no bone being present. This graft-like biologic response to a porous HA matrix confirmed its ability to serve as a bone graft substitute in clinical applications. The absence of any decrease over time confirmed the relative permanence of the HA matrix. The lack of inflammatory cells in the biopsies, along with the formation of a connective tissue protective barrier in the exposed specimens, suggests that host responses to contamination were not impaired by the porous HA matrix.

Adolescent↗

PubMed2006

Evaluation of substitutes for bone: comparison of microradiographic and histological assessments.

We created defects of standard size in the frontal bones of adult pigs and filled them with four different materials. On six occasions (at 1, 2, 4, 8, 12, and 26 weeks), samples were harvested, and evaluated by computing microradiographic images. We examined the specimens histologically as controls. After insertion of anorganic materials, microradiographic evaluation was easy and precise, and there were no significant differences between them and the histological controls (p=0.2). A quantitative evaluation of chemically sterilised bone by computer was not possible for more than 4 weeks.

Animals↗

PubMed2006

Regeneration of bicortical defects in the iliac crest of estrogen-deficient sheep, using new biodegradable polyurethane bone graft substitutes.

Porous scaffolds for cancellous bone graft substitutes were prepared from new experimental biodegradable aliphatic polyurethane elastomers with varying hydrophilicity. The ratios of the hydrophilic-to-hydrophobic content in the polymers were 30-70, 50-50, and 70-30%, respectively. The hydrophilic component consisted of poly(ethylene oxide) diol and the hydrophobic component of poly(epsilon-caprolactone) diol. To promote the materials' biological performance, the calcium complexing moiety, the polysaccharide, and vitamin D(3) were incorporated into the polymer chain upon synthesis. The scaffolds had an interconnected porous structure with an average pore size in the range of 300-2,000 microm and pore-to-volume ratios of (85 +/- 5)%. The bone substitutes were implanted (press-fit) in biocortical 10 x 10 mm(2) defects created in the tuber coxae of 21 skeletally mature Warhill ewes, which were ovariectomized 12 months prior to implantation. At the time of euthanasia at 18 and 25 months, all the defects in the ilium implanted with polyurethane bone substitutes had healed with new bone. The extent of bone healing depended on the chemical composition of the polymer from which the implant was made, although for the same material there were animal-related differences in healing. The structure of the newly formed cancellous bone was radiographically and histologically similar to the native bone. The implants from polymers with the incorporated calcium-complexing additive were the most effective promoters of bone healing, followed by those with vitamin D(3) and polysaccharide-containing polymer. There was no bone healing in the control defects.

Absorbable Implants↗

PubMed2006

The manufacture of synthetic non-sintered and degradable bone grafting substitutes.

A new synthetic bone grafting substitute (NanoBone, ARTOSS GmbH, Germany) is presented. This is produced by a new technique, the sol-gel-method. This bone grafting substitute consists of nanocrystalline hydroxyapatite (HA) and nanostructured silica (SiO2). By achieving a highly porous structure good osteoconductivity can be seen. In addition, the material will be completely biodegraded and new own bone is formed. It has been demonstrated that NanoBone is biodegraded by osteoclasts in a manner comparable to the natural bone remodelling process.

Animals↗

PubMed2002

Evaluation of Bioglass/dextran composite as a bone graft substitute.

Allogenic and alloplastic bone graft substitutes serve either as bioinert or bioactive osteoconductors. Bioglass is a bioactive osteoconductor and also shows osteoproductive effects due to its high level of bioactivity. However, the material lacks some cohesiveness when used in augmenting certain bony surfaces, i.e. large or pleomorphic defects. The addition of medium molecular weight dextran modifies the particulate to a putty consistency and improves the handling characteristics. The objective of this study is to evaluate the influence of dextran upon the bioactive properties of Bioglass. Standardized bony defects in the lateral femoral condyles in adult New Zealand white rabbits were filled with one of five material groups: (1) autogenous bone; (2) Bioglass particulate; (3) Bioglass particulate mixed with dextran to a putty-like consistency; (4) a mixture of Bioglass and autogenous bone; (5) a mixture of Bioglass putty with autogenous bone. Postoperative healing was observed after periods of 2 days, 1, 2, 3, 6 and 12 weeks. Results showed no evidence of toxicity in the dextran-containing materials, and defects in all test groups showed 100% bony ingrowth within 6 weeks. The addition of medium molecular weight dextran did not appear to alter the bioactive properties of Bioglass and had no adverse influence upon the ingrowth of bone into the defect sites.

Animals↗

PubMedDate not supplied

New horizons in orthopaedics: a rational discussion of biologics and bone graft substitutes.

Numerous inductive proteins, conductive substrates, and autogenous cellular concentration techniques have become clinically available as substitutes for autogenous bone graft. This review presents a critical analysis of their preclinical and clinical efficacy. In many instances, the widespread use of these materials must be questioned based on the limited clinical data available. A thorough knowledge of these materials is crucial for the surgeon to match the material to its defined indications.

Biocompatible Materials↗

PubMed1997

Nationwide survey of bone grafting performed from 1980 through 1989 in Japan.

Nationwide surveys were conducted in 1985 and 1989 on the status of bone grafting performed in Japan. At the first survey, questionnaires were sent to 527 hospitals, with 218 responding. Of 26,800 bone grafts performed, 96.4% were autografts, and the remaining 3.6% were allografts and xenografts. Most allografts were bone chip grafts (85%), followed by massive bone grafts excluding osteoarticular grafts (14%). Osteoarticular allografts and whole bone allografts composed only 0.4% and 0.5% of the total, respectively. At the second survey, questionnaires were sent to 2053 hospitals, with 967 responding. The use of synthetic bone substitutes and bone grafts was investigated in the second survey. Of 87,994 bone grafts performed, 94.3% were autografts, 3.2% were synthetic bone substitutes, 1.9% were banked bone allografts, 0.4% were fresh allografts, and 0.2% were xenografts. Most of all grafts were bone chip grafts (57.1%), followed by massive bone grafts excluding osteoarticular grafts (40.3%). Osteoarticular grafts and whole bone grafts accounted for only 0.3% and 2.3% of the totals, respectively. Although the number of patients requiring bone grafts increased yearly, bone allografts were not widely used in Japan.

Bone Diseases↗

PubMed2004

[Diaphyseal defect repair with nacre/polylactic acid composite artificial bone in rabbits].

OBJECTIVE: To evaluate the biocompatibility, degradation and bone formation activity of a new bone substitute for bone grafting, nacre/polylactic acid composite artificial bone (NPCB). METHODS: Radial bone defects 1.5 cm in length were induced in 32 New Zealand rabbits and immediately filled with NPCB or nothing. The animals' local and whole body responses to the implants were observed after the operation, and the serum calcium levels were detected 1 week and 4 weeks postoperatively. Tissue response, new bone formation in the defects and degradation of the implants were evaluated by X-ray, and examination of the bone mineral content (BMC) in the defects and histomorphological analysis were performed after the rabbits were sacrificed. RESULTS: All the rabbits survived the operation and the incisions healed smoothly. No significant difference was noted in the serum calcium level between 1 day before operation, 1 week and 4 weeks postoperation. BMC in the defects of the rabbits with NPCB grafts increased more rapidly than that in the control group 6-12 weeks after the operation and began to decrease after 12 weeks. Gross, X-ray and histological observations revealed that NPCB possessed osteoconductive activity and new bone ingrowth in the implants was found during the whole experiment. At 16 weeks, the defects grafts were almost completely repaired with NPCB while the defects in the control group remained nonunion. Biodegradation of the implants was observed early at 6 weeks, with numerous macrophage and multinuclear giant cells containing phagocytosed NPCB particles around the implants at 12 weeks, but NPCB remnants were still visible at 16 weeks. CONCLUSION: As a bone substitute, NPCB possesses good biocompatibility, biodegradability and osteoconductive activity.

Absorbable Implants↗

PubMedDate not supplied

Osteoblastic differentiation of rabbit mesenchymal stem cells loaded in A carrier system of Pluronic F127 and Interpore.

BACKGROUND: Ideally, bone tissue engineering products should have the ability of osteoconduction and osteoinduction. According to the tissue engineering principle, mesenchymal stem cells (MSCs) combined with an appropriate scaffold can be used as a bone substitute for bone defects. Here we used Interpore as a scaffold loaded with MSCs mixed in hydrogel (Pluronic F127). In order to demonstrate the osteogenic ability of MSCs in the hydrogel, cell/hydrogel scaffold constructs were cultured in an induction medium to elicit an osteoblastic response. METHODS: MSCs aspirated from rabbit bone marrow were cultured in induction medium. MSCs were then loaded into scaffold Interpore with the aid of hydrogel (Pluronic F127). After culture for 7 and 14 days, osteoblastic differentiation ability was tested using Alizarin Red S stain, reverse transcription polymerase chain reaction (RT-PCR), measurement of calcium and alkaline phosphatase levels, and scanning electron microscopy (SEM). RESULTS: Calcium and alkaline phosphatase levels both increased after 7 and 14 days incubation. Alizarin Red S staining revealed MSCs could survive and differentiate to osteoblasts in the cell/hydrogel scaffold. RT-PCR showed mRNA expression of osteopontin and Core binding factor alpha 1 (Cbfa1). SEM revealed growth of osteoblast-like cells on ceramic pores. CONCLUSIONS: Osteoconductive bone substitute (Interpore) has been used clinically for a long time. This study showed that MSCs could be held on Interpore with the aid of hydrogel (Pluronic F127) and that they could differentiate to osteoblasts.

Alkaline Phosphatase↗

PubMed1999

Augmentation of distal radius fracture fixation with coralline hydroxyapatite bone graft substitute.

We implanted coralline hydroxyapatite bone graft as a substitute for autogenous bone graft to support the reduced articular surface of 21 consecutive patients with distal radius fractures treated with external fixation and K-wires. The purpose of this single-cohort retrospective study was to report the outcomes of treatment with this material, complications associated with its use, and its efficacy in supporting the articular surface reduction. Eighteen patients were available for independent evaluation of motion, subjective outcome analysis, and final radiographic analysis at an average of 35 months after surgery. Wrist motion averaged 90% of the uninjured wrist and grip strength measured 75% of the uninjured side. Results in 17 of the 18 cases were rated as good or excellent by the criteria of Gartland and Werley; 12 by the criteria of Green and O'Brien. Seventeen had good or excellent radiographic results by the modified Lidstrom radiographic scoring system. The average DASH functional/symptom score was 90.3 (maximum, 100). Radiographic parameters were restored to an average of 12 mm radial length, 4 degrees volar tilt, 23 degrees radial inclination, and 0.6 mm positive ulnar variance. Articular reduction was maintained in all patients. A complication related to the use of coral was a 0.5 mm prominence of coralline hydroxyapatite beyond the subchondral line at the radiocarpal joint in 1 patient, which was not present on final radiographs. Coralline hydroxyapatite was effective at maintaining articular surface reduction when used in combination with external fixation and K-wires and had a safety profile comparable to other forms of treatment.

Bone Substitutes↗

PubMed2001

Synthetic bone graft substitutes.

Replacement of extensive local bone loss is a significant clinical challenge. There are a variety of techniques available to the surgeon to manage this problem, each with their own advantages and disadvantages. It is well known that there is morbidity associated with harvesting of autogenous bone graft and limitations in the quantity of bone available. Alternatively allografts have been reported to have a significant incidence of postoperative infection and fracture as well as the potential risk of disease transmission. During the past 30 years a variety of synthetic bone graft substitutes has been developed with the aim to minimize these complications. The benefits of synthetic grafts include availability, sterility and reduced morbidity. The present article examines the relevance of synthetic bone graft substitutes, their mechanical properties and clinical application.

Aluminum Oxide↗

PubMed1995

Tricalcium phosphate and osteogenin: a bioactive onlay bone graft substitute.

The disadvantages of autogenous bone grafts has prompted a search for a dependable onlay bone graft substitute. A combination of tricalcium phosphate, a resorbable ceramic, and osteogenin, an osteoinductive protein, was evaluated as an onlay bone graft substitute in a rabbit calvarial model. Twenty-eight tricalcium phosphate implants (15 mm diameter x 5 mm; pore size, 100-200 microns) were divided into experimental and control groups and placed on the frontal bone of 14 adult New Zealand White rabbits. In the experimental animals, 185 micrograms of osteogenin was added to each implant. In the control animals, the implants were placed untreated. Implants were harvested at intervals of 1, 3, and 6 months, and evaluated using hematoxylin and eosin histology, microradiography, and histomorphometric scanning electron microscope backscatter image analysis. At 1 month there was minimal bone ingrowth and little tricalcium phosphate resorption in both the osteogenin-treated and control implants. At 3 months, both the osteogenin-treated and control implants showed a modest increase in bone ingrowth (8.85 percent versus 5.87 percent) and decrease in tricalcium phosphate (32.86 percent versus 37.08 percent). At 6 months, however, the osteogenin-treated implants showed a statistically significant increase in bone ingrowth (22.33 percent versus 6.96 percent; p = 0.000) and decrease in tricalcium phosphate (27.25 percent versus 37.80 percent; p = 0.004) compared with the control implants. The bone within the control implants was mostly woven at 6 months, whereas the osteogenin-treated implants contained predominantly mature lamellar bone with well-differentiated marrow. All implants maintained their original volume at each time interval studied. The tricalcium phosphate/osteogenin composite, having the advantage of maintaining its volume and being replaced by new bone as the tricalcium phosphate resorbs, may be applicable clinically as an onlay bone graft substitute.

Animals↗