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At least 307 records · Page 17Linked to original sources

Sustained release of cis-hydroxyproline in the treatment of experimental proliferative vitreoretinopathy in rabbits.

PURPOSE: To evaluate the efficacy of sustained-release cis-4-hydroxyproline (CHP), a proline analog that inhibits collagen secretion, on experimental proliferative vitreoretinopathy (PVR) in rabbits. METHODS: To demonstrate the sustained release of CHP we developed scleral implants weighing 8.5 mg made of a homogeneous mixture of poly( D, L-lactide-co-glycolide) (PLGA) and various doses of CHP. The CHP release profiles were evaluated by high-performance liquid chromatography in vitro. Scleral implants loaded with 20% and 15% of CHP and made from PLGA (copolymer ratios 65/35 and 50/50; mean molecular weights 103,000 and 93,000, respectively) were used to treat experimental PVR and the efficacy was studied. In treated eyes, two PLGA 65/35 implants ( n=7), PLGA 50/50 implants ( n=6), or a PLGA 65/35 and a PLGA 50/50 implant ( n=9) were inserted at the pars plana, followed by PVR induction with autologous fibroblasts. Control eyes ( n=18) received two implants without CHP. Ocular tissue toxicity was evaluated histologically. RESULTS: In vitro release studies demonstrated a triphasic release pattern. The PLGA 65/35 and PLGA 50/50 implants released CHP over 4 and 7 weeks, respectively. The PLGA 65/35 implants decreased the incidence of retinal detachment from 89% (in controls) to 57% on day 28. When both PLGA 65/35 and PLGA 50/50 implants were used, the inhibitory effect was synergistically enhanced ( p=0.0034), while implantation with only PLGA 50/50 implants had no significant effect on PVR. No toxic reactions were observed. CONCLUSION: These results suggest that the biodegradable polymeric implants containing CHP represent a potential treatment for PVR.

Absorbable Implants↗

In vivo-in vitro study of biodegradable and osteointegrable gentamicin bone implants.

Three implants composed of phosphate (25% hydroxyapatite, 75% tricalcium phosphate), 20% poly(DL-lactide) (DL-PLA; weight-average molecular weight (Mw), 30 kD) and 3% gentamicin sulphate (GS) were assayed in vitro and in vivo to study their release profiles as potential drug delivery systems to prevent or treat osteomyelitis. To prolong GS release, some implants were coated with poly(lactide-co-glycolide) (PLGA; Mw, 100 kD; I-PLGA) or DL-PLA (Mw, 200 kD; I-PLA). GS levels were measured in bone, kidney and blood after implantation into the femur of rats. The release profiles show a burst in the first few days, followed by a slower release rate. After I-PLA implantation, bone antibiotic concentrations higher than the minimum bactericidal concentration were maintained for 4 weeks. A linear correlation between in vitro and in vivo GS release was found to continue until complete drug release. Histological and radiological analysis showed that the implants were well tolerated and gradual new bone formation was observed.

Absorbable Implants↗

A bioabsorbable fixation implant for use in proximal interphalangeal joint (hammer toe) arthrodesis: Biomechanical testing in a synthetic bone substrate.

The surgical correction of hammer toe deformity of the lesser toes is one of the most commonly performed forefoot procedures. In general, percutaneous Kirschner wires are used to provide fixation to the resected proximal interphalangeal joint. Although these wires are effective, issues such as pin tract infections as well as difficult postoperative management by patients make alternative fixation methods desirable. This study biomechanically compared a threaded/barbed bioabsorbable fixation implant made of a copolymer of 82% poly-L-lactic acid and 18% polyglycolic acid with a 1.57-mm Kirschner wire using the devices to fix 2 synthetic bone blocks together. Constructs were evaluated by applying a cantilever load, which simulated a plantar force on the middle phalanx. In all cases, the failure mode was bending of the implant, with no devices fracturing. The stiffness (approximately 6-9 N/mm) and peak load (approximately 8-9 N) of the constructs using the 2 systems were equivalent. Accelerated aging at elevated temperature (47 degrees C) in a buffer solution showed that there was no reduction in mechanical properties of the bioabsorbable system after the equivalent of nearly 6 weeks in a simulated in vivo (37 degrees C) environment. These results suggest that the bioabsorbable implant would be a suitable fixation device for the hammer toe procedure.

Absorbable Implants↗

Resorbable cages for spinal fusion: an experimental goat model.

OBJECT: A biomechanical cadaveric study and an in vivo monosegmental spinal fusion study were performed to evaluate a novel bioresorbable poly(L-lactic acid) (PLLA) cage. METHODS: The yield strength of a spinal segment was chosen as the main design parameter for the resorbable cages to be used in a goat model. In a 3-year in vivo study the authors found fusion to be significantly faster and more complete when using PLLA cages compared to titanium cages with the same dimensions. In the PLLA group, the intervertebral grafting height did not change and bone remodeling within the cage was completed 2 years after implantation. In terms of degradation of the PLLA, similar features were observed in vivo and in vitro. CONCLUSIONS: Degradation was almost completed 3 years after implantation. Tissue reaction was mild during the 3-year period.

Absorbable Implants↗

Resorbable cages for spinal fusion: an experimental goat model.

A biomechanical cadaver study and an in vivo monosegmental spinal fusion study were performed to evaluate a novel bioresorbable poly-L-lactic acid (PLLA) cage. The yield strength of a spinal segment was chosen as the main design parameter for the resorbable cages to be used in a goat model. A 3-year in vivo study revealed a significantly faster and more complete fusion using PLLA cages as compared to titanium cages with the same dimensions. In the PLLA group, the intervertebral grafting height did not change and bone remodeling within the cage was completed 2 years after implantation. In terms of degradation of the PLLA, similar features were observed in vivo and in vitro. Degradation was almost completed 3 years after implantation. Tissue reaction was mild during the 3-year period.

Absorbable Implants↗

Comparison of the tissue response to absorbable self-reinforced polylactide screws and metallic screws in the fixation of cancellous bone osteotomies: an experimental study on the rabbit distal femur.

The availability of absorbable fracture-fixation devices for clinical use calls for better knowledge of the reaction of bone tissue to absorbable polyester implants as compared with similar metallic devices. To examine and compare the tissue response to biodegradable and metallic screws within cancellous bone, a transverse transcondylar osteotomy of the distal femur was fixed with absorbable self-reinforced polylevolactide screws in 35 rabbits and with stainless-steel screws in 35 rabbits. New bone formation and consolidation of the osteotomy were examined histologically, histomorphometrically, and microradiographically within standardized sample fields 1, 3, 6, 12, 24, 36, and 48 weeks postoperatively. The intact contralateral femur served as the control. A vigorous osteoconductive response to the polylevolactide screws was observed at 3 weeks postoperatively, and the osteoid surface fraction was significantly higher in all follow-ups than in the contralateral femora. In the femora with metallic screws, new bone formation was seen 3, 6, and 12 weeks postoperatively, but at 24, 36, and 48 weeks the osteoid surface fraction did not differ significantly from that of the intact control femora. The total bone area was significantly larger in the femora with self-reinforced polylevolactide screws than in the control bone 6-48 weeks postoperatively; in the femora with metallic screws, this was found only at 6 and 12 weeks. After 48 weeks, the femora fixed with metallic screws had statistically smaller total bone area than the intact control femora. Solid bone union was seen in 84% of the osteotomies in the self-reinforced polylevolactide group and in 76% of those in the metallic group after 3 weeks or more. No signs of degradation of the self-reinforced polyleuolactide implant and only a mild foreign-body reaction with no accumulations of inflammatory cells to either self-reinforced polylevolactide or metallic screws were observed during the follow-up period. Both types of screws seemed to induce an osteostimulatory response around their threads. This phenomenon was transient for metallic screws but lasted for at least 48 weeks for self-reinforced polylevolactide screws. The polylevolactide screw does not seem to cause osteopenia at the implantation site. The fixation properties of both self-reinforced polylevolactide screws and metallic screws appear to be sufficient for the fixation of small fragments of cancellous bone.

Animals↗

Measurement of meniscofemoral contact pressure after repair of bucket-handle tears with biodegradable implants.

INTRODUCTION: Biodegradable implants are frequently used for meniscus repair. Articular cartilage damage has been reported recently after meniscus repair with biodegradable implants. The aim of the study was to investigate the meniscofemoral contact pressure at the posterior horn of the medial and lateral meniscus after repair of bucket-handle lacerations. MATERIALS AND METHODS: Specimens were mounted in a materials testing machine (Bionix 858, MTS) which was equipped with a load cell. The quadriceps tendon was attached to a hydraulic cylinder, and knee motion was controlled via tension of the quadriceps tendon. A piezo-resistive system (Tekscan, Boston, MA, USA) measured the meniscofemoral contact pressure. Five different types of biodegradable implants (Arrow, Dart, Fastener, Stinger and Meniscal Screw) and horizontal suture (no. 2 Ethibond) were tested. The knee was extended from 90 degrees of flexion to 0 degrees under a constant load of 350 N due to adjustment of the tension force of the quadriceps tendon. The femorotibial pressure and contact area were recorded at 0 degree, 30 degrees, 60 degrees and 90 degrees of flexion. RESULTS: The meniscofemoral pressure did not increase after meniscus repair with biodegradable implants or sutures. The meniscofemoral peak pressure at the posterior horn was 1.46+/-1.54 MPa in the medial compartment and 1.08+/-1.17 MPa in the lateral compartment at full knee extension. The meniscofemoral pressure increased significantly in both compartments with knee flexion from 0 degree to 90 degrees. CONCLUSION: Biodegradable implants for meniscus repair do not affect the meniscofemoral pressure. However, there remains a risk of damage to the cartilage when barbed implants are used. If the implant is not entirely advanced into the meniscus, the sharp head or some of the barbs at the column of the implant may come into direct contact with the articular cartilage of the femoral condyle or tibial plateau. The authors presume that incorrect positioning of the implant seems to be the major reason for cartilage damage.

Absorbable Implants↗

Degradable injectable bone cement in maxillofacial surgery: indications and clinical experience in 27 patients.

BACKGROUND: A carbonated apatite cement (NORIAN SRS) was used as a bone mineral substitute for the calvaria or viscerocranium in 27 patients. It has the consistency of a paste and hardens at physiologic pH and body temperature due to dahllite crystallization, which has the stoichiometric formula Ca(8.8)(HPO(4))(0.7)(PO(4))(4.5)(CO(3))(0.7)(OH)(1.3). MATERIAL AND METHODS: The cement was used for posttraumatic bone defects in the orbital, periorbital or malar regions (nine patients), posttraumatic deformities of the frontal bone (six patients), tumour-dependent bony defects of the calvaria (two patients) and posttraumatic or cystic defects of the mandible (five patients). In another five patients, the material was used to augment the atrophic anterior mandible in combination with the insertion of dental implants. Follow-up varied between 6 and 40 months (mean: 29 months). RESULTS: There was no inflammatory reaction surrounding the implanted material. There was no sign of infection in any of the patients and only one case of partial wound dehiscence with superficially exposed material. The defect fillings and augmentations were successful in all patients. None of the 19 dental implants which were inserted in combination with the material showed any sign of infection or loosening. Also, there was no loosening of the implants after loading (mean follow-up: 15 months). From the check-up radiographs, the material could be seen as a dense, radio-opaque structure. There were no material fractures or dislocations. Radiologically, the material seemed to be completely replaced by bony tissue after 30 months. CONCLUSION: Our 5-year clinical experience suggests that the material is a suitable bone mineral substitute for cranio-maxillofacial surgery especially for moderate-sized defects of the calvaria and forehead bone. It has advantages over preformed, solid bone substitute materials, and, due to its initial plasticity and eventual great compressive strength, it can also stabilize dental endosseous implants in the atrophic mandible.

Absorbable Implants↗

Formulation of calcium phosphates/poly (d,l-lactide) blends containing gentamicin for bone implantation.

Implants to prevent or treat osteomyelitis are described, composed of phosphate/poly(d,l-lactide) blends containing the antibiotic gentamicin. Seven formulations of implants containing 3% gentamicin sulfate (GS) were prepared at 433 MPa and 693 MPa of compression pressure. The blends contained phosphates (25% hydroxyapatite (HAP), 75% tricalcium phosphate (TCP)) and 20% dl-PLA (weight average molecular weight, M(w): 30 kD). To prolong GS release, implants were coated with PLGA (M(w):100 kD) or dl-PLA (M(w): 200 kD). Various durations of GS release from these devices were demonstrated as feasible. Release times of more than 10 weeks were attained with implants coated with dl-PLA (M(w): 200 kD), greatly exceeding the performance of the commercial formulation.

Absorbable Implants↗

Randomized study evaluating recombinant human bone morphogenetic protein-2 for extraction socket augmentation.

BACKGROUND: Conventional dentoalveolar osseous reconstruction often involves the use of grafting materials with or without barrier membranes. The purpose of this study was to evaluate the efficacy of bone induction for the placement of dental implants by two concentrations of recombinant human bone morphogenetic protein-2 (rhBMP-2) delivered on a bioabsorbable collagen sponge (ACS) compared to placebo (ACS alone) and no treatment in a human buccal wall defect model following tooth extraction. METHODS: Eighty patients requiring local alveolar ridge augmentation for buccal wall defects (> or =50% buccal bone loss of the extraction socket) of the maxillary teeth (bicuspids forward) immediately following tooth extraction were enrolled. Two sequential cohorts of 40 patients each were randomized in a double-masked manner to receive 0.75 mg/ml or 1.50 mg/ml rhBMP-2/ACS, placebo (ACS alone), or no treatment in a 2:1:1 ratio. Efficacy was assessed by evaluating the amount of bone induction, the adequacy of the alveolar bone volume to support an endosseous dental implant, and the need for a secondary augmentation. RESULTS: Assessment of the alveolar bone indicated that patients treated with 1.50 mg/ml rhBMP-2/ACS had significantly greater bone augmentation compared to controls (P < or =0.05). The adequacy of bone for the placement of a dental implant was approximately twice as great in the rhBMP-2/ACS groups compared to no treatment or placebo. In addition, bone density and histology revealed no differences between newly induced and native bone. CONCLUSION: The data from this randomized, masked, placebo-controlled multicenter clinical study demonstrated that the novel combination of rhBMP-2 and a commonly utilized collagen sponge had a striking effect on de novo osseous formation for the placement of dental implants.

Absorbable Implants↗

The effect of site of implantation and animal age on properties of polydioxanone pins.

Absorbable polymeric orthopaedic pins (Orthosorb) of 2.0 mm diameter were implanted at different sites in mature (3.5 kg, > 5 months) and immature (5 weeks old) rabbits (total 36) for 2, 4, and 5 weeks. The sites of implantation were the medullary canal of the femur, muscles of the thigh and subcutaneous tissue of the dorsum. In mature rabbits, 1.3 mm diameter pins were also implanted in the medullary canal of the femur. The shear strength of the pins harvested from the rabbits, was measured at each time period using a fixture that shears the pins into three parts symmetrically about the load axis. In both mature and immature rabbits the rate of degradation in mechanical properties was higher in the medullary canal of bone than in the muscle and in the subcutaneous tissue (p < 0.05). The strength retention was lower in immature than in mature rabbits after 4 and 5 weeks. The 1.3-mm pins had higher initial strength (174.7 +/- 7 MPa), higher strength retention and slower degradation within the medullary canal of femur of mature rabbits as compared to the 2.0-mm pins (157.5 +/- 4.8). DSC and X-ray diffraction results of control and implanted pins showed higher initial crystallinity and a wider range of crystallite size in the 1.3-mm pins. After 5 weeks in vivo, the crystallinity increased indicating degradation within the amorphous phase. The smaller crystallites underwent recrystallization to form larger crystallites. The results indicate that site of implantation and age of recipient influence the degradation and associated effects on mechanical properties of absorbable implants. The size of the implant, though important in determining its properties, should be considered in association with its microstructure, which also plays an important role in determining strength and strength retention of absorbable polymeric systems.

Aging↗

Laser cutting: influence on morphological and physicochemical properties of polyhydroxybutyrate.

Polyhydroxybutyrate (PHB) is a biocompatible and resorbable implant material. For these reasons, it has been used for the fabrication of temporary stents, bone plates, nails and screws (Peng et al. Biomaterials 1996;17:685). In some cases, the brittle mechanical properties of PHB homopolymer limit its application. A typical plasticizer, triethylcitrate (TEC), was used to overcome such limitations by making the material more pliable. In the past few years, CO2-laser cutting of PHB was used in the manufacturing of small medical devices such as stents. Embrittlement of plasticized PHB tubes has been observed, after laser machining. Consequently, the physicochemical and morphological properties of laser-processed surfaces and cut edges of plasticized polymer samples were examined to determine the extent of changes in polymer properties as a result of laser machining. These studies included determination of the depth of the laser-induced heat affected zone by polariscopy of thin polymer sections. Molecular weight changes and changes in the TEC content as a function of distance from the laser-cut edge were determined. In a preliminary test, the cellular response to the processed material was investigated by cell culture study of L929 mouse fibroblasts on laser-machined surfaces. The heat-affected zone was readily classified into four different regions with a total depth of about 60 to 100 microm (Klamp, Master Thesis, University of Rostock, 1998). These results correspond well with the chemical analysis and molecular weight measurements. Furthermore, it was found that cells grew preferentially on the laser-machined area. These findings have significant implications for the manufacture of medical implants from PHB by laser machining.

Absorbable Implants↗

Polymers, drug release, and drug-eluting stents.

Implantable biomaterials mainly serve as physical support devices, carriers for bioactive molecules and guidance for tissue growth. For any application within or outside the cardiovascular area, biomaterials are subject to an extended set of requirements in order to establish safe application. These requirements mainly include acceptable biocompatibility and, if the material is to be degraded within the body, safe degradation characteristics. During degradation, biocompatible polymers are broken down into molecules that are metabolized and removed from the body via normal metabolic pathways. Major applications of these polymers include targeted drug delivery systems, resorbable sutures and orthopedic fixation devices. In the cardiovascular area they include biodegradable cardiovascular stents and drug-eluting stent (DES) coatings. This review focuses on general aspects of local drug delivery by implantable polymeric devices, with special emphasis on drug-eluting stents.

Absorbable Implants↗

Smart implant materials.

The combination of stimuli-sensitive implant materials and minimally invasive surgery techniques is expected to give rise to numerous applications. Biodegradable thermoplastic elastomers are presented here as an example of a group of biodegradable implant materials with shape-memory properties. Their capabilities and use in a smart suture are described.

Absorbable Implants↗

Injection molding of chondrocyte/alginate constructs in the shape of facial implants.

Over one million patients per year undergo some type of procedure involving cartilage reconstruction. Polymer hydrogels, such as alginate, have been shown to be effective carriers for chondrocytes in subcutaneous cartilage formation. The goal of our current study was to develop a method to create complex structures (nose bridge, chin, etc.) with good dimensional tolerance to form cartilage in specific shapes. Molds of facial implants were prepared using Silastic ERTV. Suspensions of chondrocytes in 2% alginate were gelled by mixing with CaSO(4) (0.2 g/mL) and injected into the molds. Constructs of various cell concentrations (10, 25, and 50 million/mL) were implanted in the dorsal aspect of nude mice and harvested at times up to 30 weeks. Analysis of implanted constructs indicated progressive cartilage formation with time. Proteoglycan and collagen constructs increased with time to approximately 60% that of native tissue. Equilibrium modulus likewise increased with time to 15% that of normal tissue, whereas hydraulic permeability decreased to 20 times that of native tissue. Implants seeded with greater concentrations of cells increased proteoglycan content and collagen content and equilibrium and decreased permeability. Production of shaped cartilage implants by this technique presents several advantages, including good dimensional tolerance, high sample-to-sample reproducibility, and high cell viability. This system may be useful in the large-scale production of precisely shaped cartilage implants.

Absorbable Implants↗

Treatment of severe peri-implant bone loss using autogenous bone and a bioabsorbable polymer that delivered doxycycline (Atridox).

With an increase of the number of implants being inserted, it is inevitable that the number of cases of peri-implantitis with loss of bone will rise. We report a case in which an autogenous cancellous bone graft was placed into the peri-implant bone defect and given protection with a bioabsorbable polymer barrier (Atridox) that released doxycycline slowly.

Absorbable Implants↗

The engineering of craniofacial tissues in the laboratory: a review of biomaterials for scaffolds and implant coatings.

Tissue engineering is a rapidly growing interdisciplinary field that focuses on the interactions between cells, growth factors, and scaffolds to produce replacement tissue and organs. Recent developments in tissue engineering technology include refinements in isolation and differentiation of progenitor cells, 3-D printing technology to produce scaffolds, new biomaterials for scaffolds, and growth factor delivery systems. The purpose of this article is to review advances in biomaterials, scaffolds, and implant coatings for craniomaxillofacial (bone) tissue engineering.

Absorbable Implants↗