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PubMed2005

Angiogenesis, endothelial cell functions, and tumor cell growth in biodegradable and nonbiodegradable devices.

Development of tissue engineering creates multiple potentials for clinical treatment and scientific research. Biodegradable collagen matrices have been found to support simultaneous autotransplantation of hepatocytes after major liver resection. Dynamic angiogenesis in biodegradable devices (BDD) and nondegradable devices (NDD) transplanted into the renal subcapsule and subcutaneous tissue was measured by the distribution of radiolabeled red blood cells and serum albumin. The circulation, microvascular integrity, and capacities of endothelial cells (adhesion, proliferation, and migration) were investigated within 2 weeks after subcutaneous transplantation of both devices. Patterns of tumor cell growth in both devices were morphologically studied. After subcutaneous transplantation, significant angiogenesis was noted at 1 week in BDD implants and from 2 weeks and on in NDD implants, with an increase in implant blood and plasma volumes. Leakage index of radiolabeled albumin in NDD implants was significantly higher than in BDD implants, while the leakage index 2 weeks after BDD implant was similar to that in subcutaneous tissues. Adhesion, proliferation and migration rates of endothelial cells isolated from both devices were higher than from subcutaneous tissues. Endothelial proliferation and migration rates in BDD implants were significantly higher at 1 week, while in NDD at 2 weeks. Tumor cells migrated and grew on the top surface of NDD with a flattened shape, while growing within the BDD forming a round mass. Endothelial capacities, angiogenetic procedure, and biological and physical characteristics of the device contribute to patterns of tumor cell growth in the device. Biodegradable collagen matrix with three-dimensional structure is suitable for simultaneous transplantation with cells without prevascularization.

Absorbable Implants↗

PubMed2006

The brain tissue response to biodegradable poly(methylidene malonate 2.1.2)-based microspheres in the rat.

The aim of this study was to follow the in vivo biodegradation as well as to appreciate the brain tissue response to poly(methylidene malonate 2.1.2) (PMM 2.1.2)-based microspheres implanted into the rat brain. Ninety-three adult Sprague-Dawley female rats were engaged in the study in which 54 underwent stereotactic implantation of blank gamma-sterilized PMM 2.1.2-based microspheres, prepared by an emulsion-extraction method. Twelve rats were implanted with the same 5-fluorouracil (5-FU)-loaded microspheres. Seventeen controls received the suspension medium alone (carboxymethylcellulose aqueous solution). The animals were sacrificed on post-operative days 1, 2, 8 and months 1, 2, 3, 6, 9, 12, 15 and 18. The brains were dissected, frozen, cut in a freezing microtome, and the slides were processed for immunohistological evaluation and scanning electron microscopy. During the first few days, the moderate inflammatory response to blank or loaded PMM 2.1.2 microspheres was largely a consequence of the mechanical trauma that occurs during surgery. The macrophagous-microglial reaction was similar to the one typically found following any damage in the CNS. There were also no differences in GFAP reactivity between the implanted animals and the controls. Blank microspheres began to degrade between 3 and 6 months, while 5-FU microspheres degraded between 8 days and 1 month. The polymer degradation generated in both cases a pronounced inflammatory and immunological reaction, leading to an important cell loss, a cerebral atrophy and to the death of several animals. PMM 2.1.2 was thus shown to be inadequate for intracerebral drug delivery.

Absorbable Implants↗

PubMed2000

Controlled release of vascular endothelial growth factor by use of collagen hydrogels.

In vivo profile of vascular endothelial growth factor (VEGF) release from collagen hydrogels was investigated comparing that of hydrogel degradation while angiogenesis induced by the released VEGF was assessed. Collagen sponges were chemically cross-linked with different amounts of glutaraldehyde for various time periods. When 125I-labeled collagen hydrogels incorporating VEGF were subcutaneously implanted into the back subcutis of mice, the hydrogel radioactivity decreased with time, the decrement profile depending on the cross-linking conditions. The radioactivity was retained for longer time periods as the glutaraldehyde concentration and cross-linking time increased. Implantation study of collagen hydrogels incorporating 125I-labeled VEGF revealed that the remaining VEGF radioactivity decreased with time and the retention period was prolonged with the decreased hydrogel biodegradation. The slower the hydrogel degradation, the longer the period of VEGF retention. The collagen hydrogel incorporating VEGF induced significant angiogenesis around the implanted hydrogel, in marked contrast to VEGF in the solution form and VEGF-free empty hydrogel. The retention period of angiogenesis became longer with a decrease of the in vivo degradation rate of hydrogels. It is possible that the slower degraded hydrogel achieves a longer period of VEGF release, resulting in prolonged angiogenetic effect. We concluded that in our hydrogel system, biologically-active VEGF was released as a result of in vivo degradation of the hydrogel.

Absorbable Implants↗

PubMed2005

In vivo degradability of hydrogels prepared from different gelatins by various cross-linking methods.

This study is an investigation to evaluate the in vivo degradation of gelatin hydrogels in terms of their number of cross-links. Various hydrogels were prepared from acidic gelatin, extracted from bovine bone, porcine skin or fish scale, and basic gelatin, extracted from porcine skin, through four types of cross-linking methods, i.e., glutaraldehyde (GA) or dehydrothermal treatment and ultraviolet (UV) or electron beam irradiation. The water content of hydrogels and their number of cross-links, calculated from the tensile modulus of hydrogels, were evaluated as the measure of hydrogel cross-linking extent. Following subcutaneous implantation of 125I-labeled gelatin hydrogels into mice, the radioactivity remaining was measured at different time intervals to assess the in vivo degradability of hydrogels. Irrespective of the gelatin type and cross-linking method, a good correlation was found between the in vivo degradability of hydrogels and their number of cross-links, which is different from the correlation to their water content. This finding indicates that the degradability of hydrogels is governed by their number of cross-links.

Absorbable Implants↗

PubMed2003

Sinus floor augmentation with beta-tricalciumphosphate (beta-TCP): does platelet-rich plasma promote its osseous integration and degradation?

When dental implants are to be inserted, sinus floor augmentation is an effective treatment procedure to improve bone height in the posterior maxilla. In addition to autogenous bone material, allogenic materials, e.g. beta-tricalciumphosphate (beta-TCP), have been used successfully. The purpose of this study was to investigate whether the combination of beta-TCP with platelet-rich plasma (PRP) enhances bony regeneration and resorption of the tricalciumphosphate material. In a randomized prospective trial, 45 sinus floor elevations were performed in 39 patients. In 22 sites, PRP was added to the beta-TCP granules, while in 23 sites beta-TCP without PRP was used. Six months later, bone specimens were harvested from the augmented region during the implant insertion procedure. The formation of new bone was about 8-10% higher when PRP was applied. A faster degradation of the ceramic bone substitute was not observed. In conclusion, when PRP was added to beta-TCP, bone regeneration was supported to a small extent. However, the resorption of beta-TCP was not accelerated and foreign-body giant cells and soft tissue surrounding the beta-TCP granules were present.

Absorbable Implants↗

PubMed2006

Clinical and histologic evaluation of the use of mandibular tori as donor site for mandibular block autografts: report of three cases.

The present paper reports on three patients who underwent localized alveolar ridge augmentation using block autografts harvested from the mandibular tori. Autogenous particulate bone graft was placed at the periphery of the block. Resorbable collagen membrane was placed above the graft material. Implant placement surgery followed at 6 to 16 months after bone grafting. During implant surgery, a biopsy was taken from the block autograft. Clinical evaluation revealed incorporation of the graft material at the recipient site. No donor site complication was noted. Histologic evaluation suggested that the block autograft was vital and in an active remodeling phase at the time of implant placement. Impressions were made intraorally before and 6 months after bone grafting. Laboratory measurements revealed 13% resorption at 6 months after bone grafting while 0.53 mL of ridge augmentation was achieved 6 months after bone grafting. Linear tomographs indicated 4.33 mm of lateral alveolar ridge augmentation. This report suggests that block autografts harvested from the mandibular tori may have the potential to maintain their vitality after bone grafting, while they may demonstrate resorption rates similar to those of autografts harvested from other intraoral donor sites.

Absorbable Implants↗

PubMed2002

Robust and prolonged gene expression from injectable polymeric implants.

We introduce an injectable system for the formation of a biodegradable DNA-containing implant that releases DNA over a 2-month period to provide a robust and prolonged gene expression at the site. Sustained delivery of the appropriate plasmid DNA resulted in sustained expression of luciferase, the persistent appearance of secreted alkaline phosphatase in the serum and small blood vessel formation in the vicinity of the implant from the delivery of the development endothelial locus-1 gene. Local expression of development endothelial locus-1 protein promotes the development of blood vessels to meet the metabolic demands of new tissue and is a paradigm for the delivery of other growth factors that act locally to aid tissue regeneration. This delivery system involves simple preparation procedures and can be injected directly into the site, hence should be a useful approach to plasmid-based gene transfer for vaccination and tissue engineering.

Absorbable Implants↗

PubMed2006

Long-term results of guided tissue regeneration therapy with non-resorbable and bioabsorbable barriers. III. Class II furcations after 10 years.

BACKGROUND: The aim of this 10-year follow-up was to evaluate the long-term results after guided tissue regeneration (GTR) therapy of Class II furcation defects using non-resorbable and bioabsorbable barriers clinically. METHODS: In nine patients with advanced periodontitis, nine pairs of contralateral Class II furcation defects were treated. Within each patient, one defect received a non-resorbable expanded polytetrafluoroethylene barrier (ePTFE; C) and the other a bioabsorbable (polyglactin 910; T) barrier by random assignment. At baseline and 12 and 120 +/- 6 months after surgery, clinical parameters were obtained. RESULTS: Twelve and 120 months after GTR therapy, statistically significant (P <0.05) horizontal clinical attachment level (CAL-H) gain was observed in both groups (C12: 1.9 +/- 0.5 mm; C120: 1.1 +/- 1.3 mm; T12: 1.9 +/- 0.8 mm; T120: 1.7 +/- 1.4 mm). However, one patient with furcations that had been assessed as Class I 12 months after GTR therapy had lost two teeth after 10 years, and another patient had lost more than 2 mm CAL-H at one furcation from 12 to 120 +/- 6 months post-surgery 10 years after implantation of an ePTFE barrier. Horizontal bone sounding revealed similar bone gain in both groups 120 +/- 6 months post-surgery (C120: 0.8 +/- 1.0 mm; T120: 1.1 +/- 1.1 mm). CONCLUSIONS: CAL-H gain achieved after GTR therapy in Class II furcations was stable after 10 years in 15 of 18 defects (83%). The study failed to show a statistically significant difference in stability of CAL-H gain between group C and T 10 years after GTR therapy.

Absorbable Implants↗

PubMed2005

Tissue anti-adhesion potential of ibuprofen-loaded PLLA-PEG diblock copolymer films.

This study was designed to evaluate the effect of polyethylene glycol (PEG) and nonsteroidal anti-inflammatory drug (ibuprofen) on the prevention of postsurgical tissue adhesion. For this, poly(L-lactic acid) (PLLA)-PEG diblock copolymers were synthesized by ring opening polymerization of L-lactide and methoxy polyethylene glycol (Mw 5000) of different compositions. The synthesized copolymers were characterized by gel permeation chromatography and 1H-nuclear magnetic resonance spectroscopy. PLLA-PEG copolymer films were prepared by solvent casting. The prepared copolymer films were more flexible and hydrophilic than the control PLLA film, as investigated by the measurements of glass transition temperature, water absorption content, and water contact angle. The drug release behavior from the ibuprofen (10 wt%)-loaded copolymer films was examined by high performance liquid chromatography. It was observed that the drug was released gradually up to about 40% of total loading amount after 20 days, depending on PEG composition; more drug release from the films with higher PEG compositions. In vitro cell adhesions on the copolymer films with/without drug were compared by the culture of NIH/3T3 mouse embryo fibroblasts on the surfaces. For in vivo evaluation of tissue anti-adhesion potential, the copolymer films with/without drug were implanted between the cecum and peritoneal wall defects of rats and their tissue adhesion extents were compared. It was observed that the ibuprofen-containing PLLA-PEG films with high PEG composition (particularly PLLA113-PEG113 film with PEG composition, 50 mol%) were very effective in preventing cell or tissue adhesion on the film surfaces, probably owing to the synergistic effects of highly mobile, hydrophilic PEG and anti-inflammatory drug, ibuprofen.

Abdominal Wall↗

PubMed2005

Biodegradable fixation of mandibular fractures in children: stability and early results.

OBJECTIVE: The aim of this study was to assess the safety and efficiency of biodegradable self-reinforced (SR-PLDLA) bone plates and screws in open reduction and internal fixation of mandible fractures in children. STUDY DESIGN: Thirteen patients (5 female, 8 male; mean age 12 years, range 5-16 years) were operated on various fractures of the mandible (2 symphyseal, 6 parasymphyseal, 4 body, 3 angle, 1 ramus, 2 condylar fractures). The mean follow-up time was 26.4 months (range 10.9-43.4 months). Intermaxillary fixation was applied in cases with concomitant condylar fractures up to 3 weeks. RESULTS: Primary healing of the fractured mandible was observed in all patients. Postoperative complications were minor and transient. The outcome of the operations was not endangered. Adverse tissue reactions to the implants, malocclusion, and growth restrictions did not occur during the observation period. CONCLUSIONS: Pediatric patients benefit from the advantages of resorbable materials, especially from faster mobilization and the avoidance of secondary removal operations. Based on these preliminary results, self-reinforced fixation devices are safe and efficient in the treatment of pediatric mandible fractures. However, further clinical investigations are necessary to evaluate the long-term reliability.

Absorbable Implants↗

PubMed2003

Regulating bone formation via controlled scaffold degradation.

It is widely assumed that coupling the degradation rate of polymers used as cell transplantation carriers to the growth rate of the developing tissue will improve its quantity or quality. To test this hypothesis, we developed alginate hydrogels with a range of degradation rates by gamma-irradiating high-molecular-weight alginate to yield polymers of various molecular weights and structures. Decreasing the size of the polymer chains increased the degradation rate in vivo, as measured by implant retrieval rates, masses, and elastic moduli. Rapidly and slowly degrading alginates, covalently modified with RGD-containing peptides to control cell behavior, were then used to investigate the effect of biodegradation rate on bone tissue development in vivo. The more rapidly degrading gels led to dramatic increases in the extent and quality of bone formation. These results indicate that biomaterial degradability is a critical design criterion for achieving optimal tissue regeneration with cell transplantation.

Absorbable Implants↗

PubMed2007

[Bridging peripheral nerve defects by means of nerve conduits].

BACKGROUND: The nerve autograft is the gold standard for the reconstruction of peripheral nerve defects. In short gaps, nerve repair by means of tubulization has become an alternative. This technique is discussed based on the current literature and our own experience. PATIENTS AND METHODS: Nerve reconstruction by means of tubulization was performed in 11 patients. Nerve gaps in the hand of up to 18 mm were reconstructed. Sensibility was assessed using static and dynamic two point discrimination (s-, d2PD) and monofilament testing 3, 6 and 12 months postoperatively. RESULTS: Three out of 11 patients complained of a temporary foreign body sensation in the area of the implant; this was persistent in one case. Four out of six patients showed excellent results with s2PD of 15 mm, S0), another poor sensibility (s2PD 15 mm, S3). D2PD and monofilament testing confirmed these results. CONCLUSIONS: Nerve reconstruction by means of tubulization seems to be a suitable method for certain indications in the reconstruction of short defects of digital and palmar nerves. Donor site morbidity can be avoided. Similarly to nerve transplantation, the operation requires microsurgical skills.

Absorbable Implants↗

PubMed2000

[A new resorbable bone-cartilage replacement transplant. Results of an animal experiment study].

Hyaline cartilage is thought to be unable to regenerate. All efforts so far--including autologous chondrocyte cell transplantation--to reconstruct cartilage defects in joints have not been totally convincing. However, mesenchymal cells are able to differentiate into chondrocytes under mechanical pressure conditions. In this study, an open porous resorbable two-layer "bioimplant" was constructed in which mechanical pressure was exerted onto mesenchymal cells when migrated into the open porous structure of the bioimplant. Differentiation of the cells into chondrocytes was thus induced. The bioimplants were implanted into the medial condyles of nine rabbits and left in place for eight or twelve weeks, respectively. In seven of these cases, cartilage formation was found, in contrary to the controls in which only connective tissue and bone had grown into the empty holes. The new bioimplants have proven their effectiveness in cartilage defect repair and might evolve in the future as a new alternative treatment of full thickness defects of joint surfaces.

Absorbable Implants↗

PubMed2004

Tissue engineering of a human sized and shaped auricle using a mold.

OBJECTIVES: The creation of a tissue-engineered auricle was initially successful in an immunocompromised nude mouse model. Subsequently, an immunocompetent porcine model successfully generated a helical construct. We wished to evaluate the novel technique of using a mold to create a complete, anatomically refined auricle in a large animal model. METHODS: Mixtures of autogenous chondrocytes and biodegradable polymers were used inside a perforated, auricle shaped hollow gold mold. Three biodegradable polymers (calcium alginate, pluronic F-127, and polyglycolic acid) were used to retain the seeded chondrocytes inside the mold. These molds, along with a control, were implanted subcutaneously in the abdominal area of 10 animals (pigs and sheep). The constructs were removed after 8 to 20 weeks and were assessed by gross morphology and histology. RESULTS: All the gold implants were well tolerated by the animals. The implants using calcium alginate (n = 3) generated constructs of the exact shape and size of a normal human ear; the histology demonstrated mostly normal cartilage with some persistent alginate. The implants with pluronic F-127 (n = 3) resulted in cartilage with essentially normal histology, although leakage outside the molds and external cartilage generation was noted. Polyglycolic acid implants (n = 3) produced no useful cartilage because of an inflammatory reaction with fibrosis. The empty control mold (n = 1) demonstrated only a very small amount of fibrous tissue inside. CONCLUSION: A tissue-engineered human sized auricle of normal anatomic definition can be generated in an immunocompetent large-animal model using a mold technique. Although further refinements will be necessary, the technique appears promising for potential use in patients with microtia.

Absorbable Implants↗

PubMed2000

Use of hydroxyapatite cement to support implants in extraction sockets.

Bioactive cements based on calcium phosphate chemistry have been developed to serve as bone substitute materials. One such commercial product, BoneSource, is a hydroxyapatite cement (HAC) used for small bone defects in the craniofacial complex. We have investigated the possibility that HAC could be used to support bone growth adjacent to dental implants placed in immediate tooth extraction sites. Variable levels of bone contact were noted up to 3 months postimplantation. Considerable loss of HAC occurred and was thought to be because of "washout" of the cement before complete cement setting. When HAC was immobile in the surgical site, the bioactive nature of the cement led to HAC resorption and bone deposition. Efforts to maintain the HAC in situ should be expanded so that the full clinical potential of the HAC can be realized.

Absorbable Implants↗

PubMed2004

Cervical spine fusion with bioabsorbable cages.

OBJECT: Although it improves rates of fusion in surgical arthrodesis, conventional spinal instrumentation is associated with several risks, including hardware extrusion that injures adjacent anatomical structures, and disuse osteopenia as a result of stress shielding. The long-term effects of indwelling spinal instrumentation, although incompletely documented, may be detrimental. One way to avoid such problems would be to use bioabsorbable implantation devices. In this pilot study, performed in 1998 and 1999, the authors evaluated the use of a bioabsorbable interbody fusion device in a goat cervical spine model. METHODS: Forty-two goats underwent two-level anterior cervical discectomy and fusion: eight received iliac crest autograft; 16 received a cage implant composed of 70:30 poly(L-lactide-co-D,L-lactide)/polyglycolic acid (70:30 PLDLLA/PGA) filled with either autograft or recombinant human bone morphogenetic protein-2 (rhBMP-2); and 18 received a cage implant composed of 85:15 PLDLLA/PGA filled with either autograft or rhBMP-2. Animals were killed at 3, 6, and 12 months postsurgery, and their cervical spines were evaluated histologically, radiographically, and physically for fusion. A primarily fibrous union was demonstrated in all animals killed at 3 months. At 6 months, bone trabeculae had become more prominent and the fibrous response less so in all cohorts. This occurred most frequently in the animals that underwent fusion with the 70:30 PLDLLA/PGA cages filled with rhBMP-2, in which 63% attained a histologically confirmed union that contained quantitatively more bone and less fibrous tissue than in the other cohorts; 63% of the unions in the aforementioned cohort were graded quantitatively as being stable. CONCLUSIONS: In this study the authors have established that the 85:15 PLDLLA/PGA cages are absorbed too quickly to be functionally useful in this model. The 70:30 PLDLLA/PGA cages worked as well as tricortical autograft when filled with cancellous autograft, and better when filled with rhBMP-2. At 6- and 12-month follow-up review, the 70:30 PLDLLA/PGA cages had not yet begun to be absorbed. There was little if any inflammatory response to these cages at 6 months. Future studies should include biomechanical and microradiographic testing, and a longer follow-up period is necessary in this model to determine when the 70:30 PLDLLA/PGA cages are absorbed.

Absorbable Implants↗

PubMed2004

Resorbable poly-L-lactide plates and screws for the treatment of mandibular condylar process fractures: a clinical and radiologic follow-up study.

PURPOSE: The purpose of this study was to determine whether a resorbable poly-l-lactide (PLLA) miniplate system could be used to treat mandibular condylar process fracture. PATIENTS AND METHODS: Fourteen patients (12 males, 2 females, aged 23.1 +/- 5.7 years) who had mandibular condylar process fractures treated with PLLA implants were recalled for follow-up clinical and radiologic examinations at 3 years. RESULTS: Mouth opening recovered to more than 35 mm and occlusion was stable in all patients. There was no facial asymmetry 3 months postoperatively. Two patients had mild chronic postoperative tenderness at the implantation site; however, there was no wound infection. All fractured mandibular condyles showed anatomic good reduction and long-term stability with the use of resorbable miniplates and screws. Bone healing was satisfactory in all patients, and there was no evidence of abnormal resorption of the condylar process. The screw holes remained evident after 3 years. Screw holes in 2 patients showed enlargement on radiographic examination. CONCLUSION: The PLLA miniplate system provides reliable stability when used for the fixation of mandibular condylar process fractures.

Absorbable Implants↗

PubMed2005

Microwave irradiated collagen tubes as a better matrix for peripheral nerve regeneration.

Collagen is one of the best materials used for nerve guide preparation due to its biocompatibility and desirable tensile strength. In this work, we have compared regeneration and functional reinnervation after sciatic nerve resection with bioresorbable crosslinked collagen guides in 10 mm gap. The crosslinking was carried out either with glutaraldehyde (GTA) or microwave irradiation (MWI). The multilayered collagen membrane used for nerve guides are prepared by lamellar evaporation technique. Functional evaluations of the regenerated nerves were performed by measuring the sciatic functional index (SFI), nerve conduction velocity (NCV), and electromyography (EMG). Transmission electron microscopic studies showed growth of axonal cable with fewer myelinated axons, Schwann cells and more unmyelinated axons present in the case of group treated with uncrosslinked collagen tubes after 1 month of implantation. However, we have observed more myelinated axons in the case of autograft, GTA, and MWI crosslinked collagen tube implants across the gap of 1 cm after the same period of implantation. Smaller myelinated fiber diameter was observed in the case of GTA crosslinked collagen tube group when compared with the autograft and MWI collagen tube groups. There were more myelinated axons during the 3rd and 6th months postoperatively using these conduits as substantiated by light microscopic studies of the regenerated nerve. The conduction velocity and recovery index improved significantly after 5 months reaching the normal values in the autograft and MWI crosslinked collagen groups compared to GTA and uncrosslinked collagen tubes.

Absorbable Implants↗