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Results for “Absorbable Implants”

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PubMed2003

Dead-ended autologous connective tissue chambers in peripheral nerve repair--early observations.

The effects of the repair of nerve gap injuries are still unsatisfactory, despite the great progress in microsurgery. Until now, there is no effective method to induce the regeneration of the transected peripheral nerve when its distal stump is missing. The aim of this work was to examine whether the implantation of dead-ended connective tissue chambers can promote the outgrowth of injured peripheral neurites. This method differs from all previous nerve guides because it totally eliminates the distal part of the nerve and restricts the influence of surrounding tissues. We have also tried to establish whether some neurotrophic factors can be applied by means of these chambers. The results of this work show that dead-ended autologous connective tissue chambers can be a useful tool in peripheral nerve injuries treatment, even when the distal part of the nerve is missing.

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PubMed2001

Biodegradation and strength retention of poly-L-lactide screws in vivo. An experimental long-term study in sheep.

BACKGROUND AND AIMS: Poly-L-lactide implants have gained popularity in the fixation of fractures and osteotomies in the past decade. The aim of the present experimental long-term study was to examine the degradation and strength retention of self-reinforced poly-L-lactide (SR-PLLA) lag-screws and the bone tissue response. MATERIAL AND METHODS: A total of 27 young adult sheep were used. Self-reinforced poly-L-lactide (SR-PLLA) lag-screws of 6.3 mm were implanted in the left proximal femur of nine sheep. At two, three and five years three of the sheep were sacrificed and the degradation was studied radiologically, microradiographically and histologically. For the strength retention measurements five SR-PLLA lag-screws of 6.3 mm and five lag-screws of 4.5 mm were implanted in the subcutaneous tissue of the five sheep and lag-screws of 6.3 mm for the pull-out test in the left proximal femur of 20 sheep. At 0, 12, 18, 24, 32, and 36 weeks bending and shear strength, molecular weight and pull-out measurements were performed. RESULTS: At five years no SR-PLLA material could be seen. The implant area was surrounded by high density bone with bone ingrowth in the screw area. At 36 weeks the bending strength of the 6.3 mm screws had decreased from 257.9 MPa to 36.4 MPa and the shear strength from 131.8 MPa to 19.8 MPa. The pull-out strength of the lag-screws of 6.3 mm in diameter decreased from 1507 N to 331 N in 24 weeks. CONCLUSIONS: SR-PLLA lag-screws showed high initial values, a controlled strength retention and gradual degradation process making the use of them safe also in demanding fixations.

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PubMed2006

Angiogenic and inflammatory response to biodegradable scaffolds in dorsal skinfold chambers of mice.

For tissue engineering, scaffolds should be biocompatible and promote neovascularization. Because little is known on those specific properties, we herein studied in vivo the host angiogenic and inflammatory response after implantation of commonly used scaffold materials. Porous poly(L-lactide-co-glycolide) (PLGA) and collagen-chitosan-hydroxyapatite hydrogel scaffolds were implanted into dorsal skinfold chambers of balb/c mice. Additional animals received cortical bone as an isogeneic, biological implant, while chambers of animals without implants served as controls. Angiogenesis and neovascularization as well as leukocyte-endothelial cell interaction and microvascular permeability were analyzed over 14 day using intravital fluorescence microscopy. PLGA scaffolds showed a slight increase in leukocyte recruitment compared to controls. This was associated with an elevation of microvascular permeability, which was comparable to that observed in isogeneic bone tissue. Of interest, PLGA induced a marked angiogenic response, revealing a density of newly formed capillaries almost similar to that observed in bone implants. Histology showed infiltration of macrophages, probably indicating resorption of the biomaterial. In contrast, hydrogel scaffolds induced a severe inflammation, as indicated by an approximately 15-fold increase of leukocyte-endothelial cell interaction and a marked elevation of microvascular permeability. This was associated by induction of apoptotic cell death within the surrounding tissue and a complete lack of ingrowth of newly formed microvessels. Histology confirmed adequate engraftment of PLGA and isogeneic bone but not hydrogel within the host tissue. PLGA scaffolds show a better biocompatibility than hydrogel scaffolds and promote vascular ingrowth, guaranteeing adequate engraftment within the host tissue.

Absorbable Implants↗

PubMed2002

Comparative study of tissue response to polyglecaprone 25, polyglactin 910 and polytetrafluorethylene suture materials in rats.

The authors evaluated the biocompatibility of three suture materials, polyglecaprone 25, polyglactin 910 and polytetrafluorethylene, implanted into subcutaneous tissue in the dorsal region of 20 Wistar albinus rats. After periods of 2, 7, 14 and 21 days, the rats were sacrificed and the specimens were processed for routine histotechnical analysis and stained with hematoxylin and eosin. The rate of fibrosis, angioblastic and fibroblastic proliferation, and also the intensity of inflammation were observed with the optic microscope. The results showed that polyglecaprone 25 suture material induced a mild inflammatory reaction, followed by polyglactin 910 and polytetrafluorethylene, respectively. Such biological behavior must be considered during the selection of the suture material to be used in oral surgery.

Absorbable Implants↗

PubMed2004

Synergistic effects of micropatterned biodegradable conduits and Schwann cells on sciatic nerve regeneration.

This paper describes a novel biodegradable conduit that provides a combination of physical, chemical and biological cues at the cellular level to facilitate peripheral nerve regeneration. The conduit consists of a porous poly(D,L-lactic acid) (PDLLA) tubular support structure with a micropatterned inner lumen. Schwann cells were pre-seeded into the lumen to provide additional trophic support. Conduits with micropatterned inner lumens pre-seeded with Schwann cells (MS) were fabricated and compared with three types of conduits used as controls: M (conduits with micropatterned inner lumens without pre-seeded Schwann cells), NS (conduits without micropatterned inner lumens pre-seeded with Schwann cells) and N (conduits without micropatterned inner lumens, without pre-seeded Schwann cells). The conduits were implanted in rats with 1 cm sciatic nerve transections and the regeneration and functional recovery were compared in the four different cases. The number or size of regenerated axons did not vary significantly among the different conduits. The time of recovery, and the sciatic function index, however, were significantly enhanced using the MS conduits, based on qualitative observations as well as quantitative measurements using walking track analysis. This demonstrates that biodegradable micropatterned conduits pre-seeded with Schwann cells that provide a combination of physical, chemical and biological guidance cues for regenerating axons at the cellular level offer a better alternative for repairing sciatic nerve transactions than conventional biodegradable conduits.

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PubMed2004

Prognostic factors for alveolar regeneration: effect of a space-providing biomaterial on guided tissue regeneration.

OBJECTIVES: There is a limited understanding of the effect of bone biomaterials on the healing potential when used in conjunction with guided tissue regeneration (GTR). The objective of this study was to evaluate the effect of a space-providing coral-derived biomaterial on alveolar bone regeneration in conjunction with GTR. METHODS: Bilateral, critical-size, 6-mm, supra-alveolar, periodontal defects were created in four young adult Beagle dogs. In a split-mouth design, the animals received an ePTFE device to provide for GTR in contralateral defect sites with or without the coral biomaterial. The animals were euthanized at 4 weeks post surgery. A histometric analysis assessed vertical regeneration of alveolar bone relative to space-provision by the ePTFE device. Because of the correlation of within-dog measurements, a mixed model ANOVA was used to analyze the data. RESULTS: There was significantly greater mean bone regeneration in sites receiving calcium carbonate coral implant GTR (cGTR) compared to GTR (p < 0.0001). Sites providing larger wound areas exhibited greater bone regeneration compared to sites exhibiting smaller wound areas (p < 0.0001). However, grouping the sites by wound area thresholds showed that bone regeneration was not significantly different in sites receiving cGTR compared to sites receiving GTR alone, irrespective of the size of the wound area (p > 0.5). CONCLUSIONS: Space-provision has a significant effect on bone regeneration following GTR. The coral biomaterial effectively enhances space-provision, and this appears to be the principal mechanism by which this biomaterial supports bone regeneration rather than postulated osteoconductive properties.

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PubMed2005

First successful implantation of a biodegradable metal stent into the left pulmonary artery of a preterm baby.

Stent implantation in the youngest patients with a congenital heart disease implicates limitations concerning further vessel growth, the need of staged redilation, and later surgical removal. The search to overcome these restrictions led to open stent designs, with a wide adaptability to the vessel growth and recently to the development of bioabsorbable stent materials. A preterm baby born at 26 weeks of gestation was referred to our clinic following inadvertent ligation of the left pulmonary artery. Despite efficient debanding, the left lung perfusion was absent. Implantation of a biodegradable 3 mm magnesium stent was performed in a hybrid procedure when the baby weighed 1.7 kg. Reperfusion of the left lung was established and persisted throughout the 4-month follow-up period during which the gradual degradation process of the stent completed. Additional interventions, should they become necessary, seem not to be limited. Despite the small size of the baby, the degradation process was clinically well tolerated. The mechanical and degradation characteristics of the magnesium stent proved to be adequate to secure reperfusion of the previously occluded left pulmonary artery. Bioabsorbable stents with different diameters may help develop new strategies in the therapy of vessel stenosis in pediatric patients.

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PubMed2003

Experimental tooth movement into bone induced by recombinant human bone morphogenetic protein-2.

OBJECTIVE: The development of biomaterials for secondary bone grafting to the alveolar cleft, recombinant human morphogenetic protein-2 (rhBMP-2) may have great potential to promote osseous regeneration. The purpose of this study was to investigate the osteoinductive activity of low-dose rhBMP-2 (10 microg/100 microL) and the biological response of newly generated bone to orthodontic stimulation, compared with previous results using high-dose rhBMP-2 (40 microg/100 microL). METHOD: After extraction of the maxillary first premolars, bone defects were surgically created in eight adult beagle dogs using a 5-mm-diameter trepan bar. The rhBMP-2 with a PLGA/gelatin sponge complex (PGS) made of gelatin and polylactic acid polyglycolic acid copolymer was immediately implanted. The osteoinductive activity of rhBMP-2 and tooth movement into the newly generated bone was evaluated based on histological and morphometric examination. RESULTS: Dramatic histological and morphometric differences were found in the time course of bone remodeling between low- and high-dose rhBMP-2. The onset of bone remodeling occurred significantly earlier in low-dose rhBMP-2. During experimental tooth movement, in contrast to high-dose rhBMP-2, with which root resorption occurred, only partial cementum resorption occurred on the pressure side with low-dose rhBMP-2. CONCLUSION: These results indicated that the proper dosage of rhBMP-2 should be determined for successful clinical application.

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PubMed2005

Short-term in vitro and in vivo biocompatibility of a biodegradable polyurethane foam based on 1,4-butanediisocyanate.

In this study short-term in vitro and in vivo biocompatibility apects of a biodegradable polyurethane (PU) foam were evaluated. The PU consists of hard urethane segments and amorphous soft segments based on a copolyester of dl-lactide and epsilon-caprolactone. The urethane segments are of uniform length and synthesized with 1,4-butanediisocyanate. The foam has good mechanical properties and will be used for tissue regeneration applications. Degradation tests were carried out in a buffer solution for twelve weeks. Cytotoxicity was determined using extract and direct contact test methods with incubation periods varying form 24 to 72 h. The foam was implanted subcutaneously for one, four and twelve weeks and the tissue response to the material was histologically evaluated. In vitro, the mass loss was 3.4% after twelve weeks. In the cytotoxicity tests the PU caused no abnormal growth behaviour, nor morphological changes or inhibition in metabolic activity. The in vivo studies showed no toxic tissue response to the PU. Connective tissue ingrowth, accompanied by vascular ingrowth was complete at twelve weeks. In vivo degradation had started within four to twelve weeks. In conclusion, the PU shows a good in vitro and in vivo biocompatibility in these short-term experiments.

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PubMed2005

Tissue engineered cartilage on collagen and PHBV matrices.

Cartilage engineering is a very novel approach to tissue repair through use of implants. Matrices of collagen containing calcium phosphate (CaP-Gelfix), and matrices of poly(3-hydroxybutyric acid-co-3-hydroxyvaleric acid) (PHBV) were produced to create a cartilage via tissue engineering. The matrices were characterized by scanning electron microscopy (SEM) and electron diffraction spectroscopy (EDS). Porosity and void volume analysis were carried out to characterize the matrices. Chondrocytes were isolated from the proximal humerus of 22 week-old male, adult, local albino rabbits. For cell type characterization, Type II collagen was measured by Western Blot analysis. The foams were seeded with 1x10(6) chondrocytes and histological examinations were carried out to assess cell-matrix interaction. Macroscopic examination showed that PHBV (with or without chondrocytes) maintained its integrity for 21 days, while CaP-Gelfix was deformed and degraded within 15 days. Cell-containing and cell-free matrices were implanted into full thickness cartilage defects (4.5 mm in diameter and 4 mm in depth) at the patellar groove on the right and left knees of eight rabbits, respectively. In vivo results at 8 and 20 weeks with chondrocyte seeded PHBV matrices presented early cartilage formation resembling normal articular cartilage and revealed minimal foreign body reaction. In CaP-Gelfix matrices, fibrocartilage formation and bone invasion was noted in 20 weeks. Cells maintained their phenotype in both matrices. PHBV had better healing response than CaP-Gelfix. Both matrices were effective in cartilage regeneration. These matrices have great potential for use in the repair of joint cartilage defects.

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PubMed2002

Electrophysiological and horseradish peroxidase-tracing studies of nerve regeneration through alginate-filled gap in adult rat spinal cord.

The spinal cord segments at T(9-10) were totally excised and the resulting gap was filled by implantation of alginate sponge in adult rats. A horseradish peroxidase-tracing study at 21 weeks after operation showed that numerous ascending and many but less numerous descending regenerating fibres traversed the alginate-filled gap, and that after re-entering the distal stump of the transected spinal cord, they extended randomly over a long distance away from the gap. Intracellular electrophysiological recording at the same postoperative time showed that both ascending and descending regenerating axons formed functional synapses with host neurons located beyond the gap. These findings suggest that alginate could be a promising material for the support of regenerating axons in the spinal cord.

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PubMed2000

Guided bone regeneration around endosseous implants using a resorbable membrane vs a PTFE membrane.

The aim of the present experimental pilot study was to assess bone regeneration underneath resorbable barrier membranes vs non-resorbable extended polytetrafluoroethylene (ePTFE) membranes in peri-implant defects. Two implants were inserted into surgically created defects on each side of the mandibles of 6 adult beagle dogs 3 months after extraction of all premolar teeth. One implant on each side was covered with a porous polylactic acid membrane or a ePTFE membrane, respectively, while the second implant served as control. Fluorochrome labelling was administered during the 1st, 5th, 12th and the 18th week. Three animals each were evaluated after 3 and 6 months. Bone regeneration was assessed by measuring the distance from the first fluorochrome label to the level of the regenerated bone immediately adjacent to the implant surface and to the top of the newly formed alveolar contour both on the lingual and buccal side. The increase in bone height was significantly higher compared to the controls under both barrier membranes after 3 months at the top of the alveolar crest but not immediately adjacent to the implant surface. After 6 months, bone height was significantly increased only at the top of the alveolar contour underneath the ePTFE membranes, while bone underneath the polylactic acid membranes showed signs of superficial resorption. It is concluded that guided bone regeneration underneath barrier membranes can restore alveolar bone contour but is not necessarily associated with a higher bone/implant contact. The use of resorbable membranes may be associated with untoward biological effects at later stages, when membrane degradation starts due to degradation products of the polymer material or decreasing membrane stability. Future efforts have to refine the relation between degradation kinetics, membrane porosity and mechanical properties of degradable barrier membranes to improve membrane performance.

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PubMed2005

Formation and resolution of ankylosis under application of recombinant human bone morphogenetic protein-2 (rhBMP-2) to class III furcation defects in cats.

OBJECTIVES: Periodontal regeneration under application of bone morphogenetic protein (BMP) is compromised by ankylosis. Ankylosis disappearance following application of BMP has been observed in the case of a small defect, which might be beneficial change for periodontal regeneration. However, the histological observation of ankylosis disappearance has not been demonstrated in a large defect. The purpose of this present study was to confirm resolution of ankylosis during periodontal regeneration by recombinant human BMP-2 (rhBMP-2) applied to class III furcation defects. MATERIAL AND METHODS: Class III furcation defects were created in the premolars of six adult cats. The rhBMP-2 material, prepared by applying rhBMP-2 to a combination of polylactic acid-polygricolic copolymer and gelatin sponge (PGS; 0.33 microg rhBMP-2/mm(3) PGS) or control material containing only PGS, was implanted into each defect. The cats were killed at 3, 6 or 12 weeks after surgery and serial sections were prepared for histological and histometrical observation. RESULTS: Ankylosis was observed in some of the rhBMP-2/PGS group at 3 and 6 weeks, but not at 12 weeks. At 6 weeks, osteoclast-like cells were visible in the rhBMP-2/PGS group with ankylosis. Residual PGS was evident between the bone and root surface in the rhBMP-2/PGS group without ankylosis at 3 weeks. CONCLUSIONS: Resolution of ankylosis by osteoclast-like cells possibly occurred under application of rhBMP-2. Residual PGS might play an important role in preventing ankylosis formation.

Absorbable Implants↗

PubMed2004

A study of the relationship between mass and physical strength of keratin bars in vivo.

A study was undertaken of the changes in the mass and physical properties of keratin bars implanted subcutaneously in adult rats. A very gradual decrease occurred in vivo in the dry weight of the bars over the period of the study (up to 18 weeks). The elastic modulus of the bars decreased abruptly when present in vivo between 3 and 6 weeks. At the same time there was an increase in the number of cavitations and fissures at the surface of the bars, and an increase in a central internal region of the bars where there was a disorganisation in structure of the polymer. A biocompatible material showing such changes in vivo is likely to be suitable for a variety of medical and surgical applications in which it provides a framework for cell invasion.

Absorbable Implants↗

PubMed2005

An in vivo evaluation of a biodegradable genipin-cross-linked gelatin peripheral nerve guide conduit material.

We evaluated peripheral nerve regeneration using a biodegradable nerve conduit, which was made of genipin-cross-linked gelatin. The genipin-cross-linked gelatin conduit (GGC) was dark blue in appearance, which was concentric and round with a rough outer surface whereas its inner lumen was smooth. After subcutaneous implantation on the dorsal side of the rat, the GGC only evoked a mild tissue response, forming a thin tissue capsule surrounding the conduit. Biodegradability of the GGC and its effectiveness as a guidance channel were examined as it was used to repair a 10 mm gap in the rat sciatic nerve. As a result, tube fragmentation was not obvious until 6 weeks post-implantation and successful regeneration through the gap occurred in all the conduits at the three experimental periods of 4, 6, and 8 weeks. Histological observation showed that numerous regenerated nerve fibers, mostly unmyelinated and surrounded by Schwann cells, crossed through and beyond the gap region 6 weeks after operation. Peak amplitude and area under the muscle action potential curve both showed an increase as a function of the recovery period, indicating that the nerve had undergone adequate regeneration. Thus, the GGC can not only be an effective aids for regenerating nerves but can also lead to favorable nerve functional recovery.

Absorbable Implants↗

PubMed2005

Tissue reactions of in situ formed dextran hydrogels crosslinked by stereocomplex formation after subcutaneous implantation in rats.

In this study, the in vivo biocompatibility of physically crosslinked dextran hydrogels was investigated. These hydrogels were obtained by mixing aqueous solutions of dextran grafted with L-lactic acid oligomers and dextran grafted with D-lactic acid oligomers. Gelation occurs due to stereocomplex formation of the lactic acid oligomers of opposite chirality. Since gelation takes some time, in situ gel formation is possible with this system. A number of sterilization methods was evaluated for their effect on the chemical and physical properties of the hydrogel. It was shown that of the investigated options (filtration, gamma irradiation, dry-heat and autoclaving) dry-heat sterilization was the preferred method to prepare sterile gels suitable for in vivo evaluations. Two types of stereocomplex gels were prepared and implanted subcutaneously in rats. The tissue reaction was evaluated over a period of 30 days. A mild ongoing foreign body reaction was observed characterized by infiltration of macrophages. Giant cells were only scarcely formed and the low numbers of lymphocytes showed that priming of the immune system is hardly involved. Importantly, the gels fully degraded in vivo within 15 days, which is in good agreement with the in vitro degradation behaviour of these gels. In conclusion, stereocomplexed dextran-oligolactic gels showed good biocompatibility which makes them suitable candidates for the design of controlled release devices for pharmaceutically active proteins.

Absorbable Implants↗

PubMed2006

Complications after zygoma fracture fixation: is there a difference between biodegradable materials and how do they compare with titanium osteosynthesis?

OBJECTIVE: Biodegradable materials are particularly useful for the fixation of zygomatic fractures. Different systems are commercially available. The aim of this study was to compare the clinical outcome of zygomatic fracture fixation using 3 biodegradable systems and a titanium osteosynthesis system. STUDY DESIGN: Patients with displaced fractures of the zygomatic bone presenting at our department from October 2001 to May 2003 were randomly allocated to 1 of 3 treatment groups for fracture fixation (study group A: LactoSorb: n = 18; study group B: BioSorb: n = 18; study group C: Delta: n = 18). Treatment outcome and complication rates were compared with a historic patient group with zygomatic fractures fixed with titanium osteosynthesis (control group D: n = 15). RESULTS: A total of 64 patients (study groups A + B + C: n = 49; control group D: n = 15) were followed for at least 24 months (range: 24 to 44 months). Forty-nine patients in the biodegradable study groups (group A: n = 15; group B: n = 17; group C: n = 17) who had their fractures fixed with biodegradable plates and screws alone or in combination with titanium plates and screws were reviewed postoperatively. Uneventful healing occurred during the entire follow-up period in 39 (80%) out of 49 patients in the biodegradable groups (A + B + C) and in 12 (80%) out of 15 patients in group D. Ten patients in groups A + B + C developed postoperative complications (infection: n = 3; soft tissue dehiscence: n = 2; implant-related tissue reactions: n = 5), compared with 3 patients in group D (soft tissue dehiscence: n = 1; unspecific pain: n = 2) (P = .97). Complications occurred in 4 patients in group A and 3 patients each in groups B and C. Smokers developed significantly more postoperative complications than nonsmokers in groups A + B + C (P = .01). CONCLUSION: There was no significant difference between biodegradable osteosynthesis materials or between biodegradable materials and titanium fixation with respect to fracture healing and postoperative complications. Postoperative complications were of a minor nature and resolved spontaneously or after local therapy. Smoking habits may play a significant role in the incidence of complications with biodegradable materials.

Absorbable Implants↗

PubMed2003

Tissue response to a newly developed calcium phosphate cement containing succinic acid and carboxymethyl-chitin.

We developed a new calcium phosphate cement containing succinic acid and carboxymethyl-chitin in the liquid component. In this study, the biocompatibility and osteoconductivity of this new cement were investigated. After mixing, cement in putty form was implanted immediately between the periosteum and parietal bone and in the subcutaneous tissues of rats. In control cement, distilled water was used instead of the liquid component. In addition to histological evaluations, analyses with X-ray diffraction and Fourier transform infrared were performed for the subcutaneously implanted cements. Histological examination showed slight inflammation around the new cement on the bone and in the subcutaneous tissue at 1 week after surgery. At 2 weeks, the cement was partially bound to the parietal bone. The extent of the surface of the new cement directly in contact with the bone increased with time, and most of the undersurface of the new cement bound to the host parietal bone by 8 weeks. Analysis by X-ray diffraction showed that the new cement in the subcutaneous tissue was transformed into hydroxyapatite by 8 weeks. These results indicate that this new calcium phosphate cement is useful as a bone substitute material.

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