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PubMed2004

Craniofacial reconstruction with a fast resorbing polymer: a 6- to 12-month clinical follow-up review.

OBJECT: Resorbable polymer implants have become a compelling option in the treatment of acquired and congenital craniofacial deformities. In particular, the resorbable polylactide and polyglycolide polymers have demonstrated excellent safety profiles in multiple in vitro, animal, and clinical studies and are currently being used in a wide variety of craniofacial applications. In pediatric craniofacial reconstruction a desirable attribute of fixation is early resorption, which may limit the duration of any effect on cranial growth. In this paper the authors discuss the biomaterial properties of a fast resorbing polymer (FRP) and the clinical results in a series of patients who participated in a 6- to 12-month study. METHODS: The authors performed craniofacial reconstruction by using FRP implants in 29 patients beginning in August 2002. All patients experienced maintenance of stable bone fixation followed by bone healing. Cosmetic results were rated satisfactory or excellent, except for one unsatisfactory cosmetic result caused by disease progression. CONCLUSIONS: Results of this study support the effectiveness of an FRP implant in a variety of craniofacial surgical procedures including craniosynostoses, fibrous dysplasia, cranial defects, and encephaloceles.

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PubMed1997

Bioabsorbable polymer science for the practicing surgeon.

The structure and function relationships of polymers have long been the purview of engineers and polymer chemists. As bioabsorbable polymer implants continue to make inroads in the medical implant armamentarium, surgeons, long familiar with the properties and handling characteristics of metal implants, may find it advantageous to become aware of some of the unique characteristics of these types of materials so that an informed decision can be made regarding their usage. In this article, we present, in relatively nontechnical terms, the salient features of polymers in general and absorbable polymers in particular.

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PubMed2005

Osteochondral repair in the rabbit model utilizing bilayered, degradable oligo(poly(ethylene glycol) fumarate) hydrogel scaffolds.

In this study, hydrogel scaffolds, based on the polymer oligo(poly(ethylene glycol) fumarate) (OPF), were implanted into osteochondral defects in the rabbit model. Scaffolds consisted of two layers-a bottom, bone forming layer and a top, cartilage forming layer. Three scaffold formulations were implanted to assess how material composition and transforming growth factor-beta1 (TGF-beta1) loading affected osteochondral repair. Critical histological evaluation and scoring of the quantity and quality of tissue in the chondral and subchondral regions of defects was performed at 4 and 14 weeks. At both time points, no evidence of prolonged inflammation was observed, and healthy tissue was seen to infiltrate the defect area. The quality of this tissue improved over time with hyaline cartilage filling the chondral region and a mixture of trabecular and compact bone filling the subchondral region at 14 weeks. A promising degree of Safranin O staining and chondrocyte organization was observed in the newly formed surface tissue, while the underlying subchondral bone was completely integrated with the surrounding bone at 14 weeks. Material composition within the bottom, bone-forming layer did not appear to affect the rate of scaffold degradation or tissue filling. However, no bone upgrowth into the chondral region was observed with any scaffold formulation. TGF-beta1 loading in the top layer of scaffolds appeared to exert some therapeutic affect on tissue quality, but further studies are necessary for scaffold optimization. Yet, the excellent tissue filling and integration resulting from osteochondral implantation of these OPF-based scaffolds demonstrates their potential in cartilage repair strategies.

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PubMed2005

Long-term evaluation of porous poly(epsilon-caprolactone-co-L-lactide) as a bone-filling material.

Porous poly(epsilon-caprolactone-co-L-lactide) (P(CL-co-LA, wt % ca. 5/95) sponges were prepared, coated biomimetically with CaP/apatite, and implanted with noncoated control sponges into rat femur cortical defects and dorsal subcutaneous space. The implants were inspected histologically at 2, 4, and 33 weeks after the operation. All implants were filled with fibrovascular tissue within 4 weeks. The femur implants were partially ossified with compact bone, which in the CaP-coated sponges was less mature and more fragmented. Approximately equal amounts of bone were observed in both types of implants. The polymer induced a mild inflammatory reaction with foreign body giant cells but no accumulation of fluid. Degradation of the polymer was slow; most of it was found intact at 33 weeks in histological samples. Nondegraded polymer seems to prevent complete ossification. Cultured osteoblasts proliferated well on apatite-coated material, whereas only a few cells were seen on noncoated material. Thus CaP/apatite coating helped the attachment of osteoblasts in cell cultures but did not offer any advantage in bone formation over noncoated material in vivo. We conclude that a shorter degradation time of P(CL-co-LA) is needed to create an optimal implant. Furthermore, in vivo experiments seem to be necessary for the estimation of osteopromotive properties of a biomaterial.

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PubMed2004

MacroPore resorbable devices in craniofacial surgery.

Resorbable polymer implants have become a compelling option in the treatment of acquired and congenital craniofacial deformities. The resorbable polylactide (PLa) and polyglycolide (PGa) polymers in particular have demonstrated excellent safety profile sin multiple in vitro, animal, and clinical studies and are currently being used in a wide variety of craniofacial applications. In this article, the authors discuss the biomaterial properties of PLa and PGa resorbable implants and provide an overview of the use of these polymers in craniofacial surgery. They conclude by relating their experience with an ongoing clinical series using MacroPore PLDLa and FRP implants for various applications,including Le Fort osteotomies, midface/monobloc internal distraction, and craniosynostosis reconstruction.

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PubMed2000

20-Hydroxyecdysone release from biodegradable devices: the effect of size and shape.

20-Hydroxyecdysone (20-OH) is a natural compound with many demonstrated effects on the physiological functions of vertebrates, particularly increased protein synthesis. Our study sought a suitable dosage form with continuous release of the drug lasting several weeks for implantation into agricultural animals. Biodegradable microparticles and implants of poly(L-lactic) and poly(DL-lactic) acids were prepared. Oligomers of these materials were synthesized, and a method of melting the binary mixture of the oligomer and 20-OH was employed. The particles were prepared simply by grinding the solidified block of the melt and sieving. Implants were prepared by extruding the melt into silicone tubes, removing the solidified content, and cutting into cylinders of 2 mm diameter and various lengths. A new method of preparation of hollow cylinders by aspirating air into silicone tubes filled with the melt was developed. The experiments demonstrated stability of 20-OH during heat treatment. Release of the active ingredient was tested in static in vitro conditions, analogous to those at the site of implantation, and prolonged drug release was obtained with both types of implant. The hollow implants gave release rates nearest to ideal zero-order kinetics and would appear most appropriate for testing in vivo.

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PubMed2000

Bioabsorbable fixation in orthopaedic surgery and traumatology.

Bioabsorbable internal fixation devices were introduced clinically in the treatment of fractures and osteotomies of the extremities at the Department of Orthopaedics and Traumatology, Helsinki University, in 1984. Since November 5, 1984, a total of 3200 patients were managed using bone or ligament fixation devices made of self-reinforced (matrix and fibres of the same polymer) bioabsorbable alpha-hydroxy polyesters. The devices used included cylindrical rods, screws, tacks, plugs, arrows, and wires. The most common indication for the use of bioabsorbable implants was the displaced malleolar fracture of the ankle. Transphyseal fixation with small-diameter, mainly polyglycolide pins was used in children. The postoperative clinical course was uneventful in more than 90% of the patients. The complications included bacterial wound infection in 4% and failure of fixation in 4%. In one-fifth of the latter cases, however, re-operation was not necessary. The occurrence of non-infectious foreign-body reactions two to three months postoperatively has been observed in 2% of the patients operated in the last few years with polyglycolide implants but none of the patients managed with polylactide implants. This inflammatory tissue response often required aspiration with a needle but did not influence the functional or radiologic result of the treatment. Owing to the biodegradability of these internal fixation devices, implant removal procedures were avoided. This results in financial benefits and psychological advantages. Bioabsorbable implants can also be used in open fractures and infection operations.

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PubMed1999

Is cellulose sponge degradable or stable as implantation material? An in vivo subcutaneous study in the rat.

The long-term behaviour of cellulose sponge implants, 10 x 10 x 5 mm in size, and tissue reactions in and around them were examined in the subcutaneous tissue of the rat from 1 to 60 weeks after implantation. The cellulose sponge used was filled up with connective tissue 4 to 8 weeks after implantation. Histologically, moderate foreign body tissue reaction inside the implant, the appearance of cracks and fissures, spotty colouration, and softening of the pore walls were observed up to 16 weeks after implantation. Later, the foreign body reaction inside the sponge became milder, the spotty colouration disappeared and micropores enlarged in the viscose cellulose matrix. Histomorphometrically, the cross-sectional area of the implants and the size of the pore wall fragments decreased, and the number of pore wall fragments increased significantly. The cellulose sponge used can be regarded as a slowly degradable implantation material. However, the time needed for the total disappearance of the cellulose sponge from subcutaneous tissue is longer than the 60 weeks.

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PubMed2001

Temporary granulomatous inflammation following collagen implantation.

Injections of bovine collagen are a common procedure for correction of folds in the face. However, this therapy is not free from side effects. We present a patient in whom a granulomatous inflammation occurred following implantation of this material. We therefore now insist on an observation interval of 4 weeks between test injection and actual treatment, as is recommended by the manufacturer.

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PubMedDate not supplied

A biomechanical comparison of repair techniques for type II SLAP lesions.

BACKGROUND: Multiple options exist for repair of superior labral tears. PURPOSE: To compare commonly used fixation techniques for superior labral tears. STUDY DESIGN: Biomechanical cadaveric study. METHODS: A comparison of the initial strengths of fixation for type II superior labral anterior posterior (SLAP) lesions was performed in three cadaveric shoulder groups, each containing seven specimens. Two groups were repaired with screw-in anchors; one group had vertical sutures, the other horizontal. Group 3 was repaired using bioabsorbable tacks. Cyclic traction was applied to the biceps tendon. Repair failure (2 mm of permanent displacement) and ultimate failure were measured. RESULTS: Specimen stiffness was similar between groups. The mean load to repair failure was 123 +/- 17 N in group 1, 114 +/- 11 N in group 2, and 95 +/- 13 N in group 3. The mean load to ultimate failure was 163 +/- 15 N, 161 +/- 12 N, and 145 +/- 12 N, respectively. Although the repair failure loads of groups 1 and 2 were 29% and 17%, respectively, greater than the tack group, the differences were not statistically significant (P >.05). All ultimate failures occurred at the labral-implant interface. CONCLUSION: Initial fixation strength of tissue tack and suture anchor repairs of SLAP lesions are comparable.

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PubMed2004

Posterior lumbar interbody fusion with bioabsorbable spacers and local autograft in a series of 27 patients.

OBJECT: The goal of this prospective study was to review a series of 27 patients who underwent bilateral posterior lumbar interbody fusion with instrumented pedicle fixation and two HYDROSORB (known generically as 70:30 poly[L-lactide-co-D,L-lactide]) rectangular cages packed with locally harvested autograft at a total of 48 levels, and to assess the safety and efficacy of this novel technique. This analysis, conducted at a mean of 26 months of follow up, is the first report of a long-term evaluation of this technique. Fusion rates and clinical outcomes are presented. METHODS: A prospective clinical and radiographic review of findings in 27 consecutive patients was performed. Fusion rates and clinical outcome were assessed at 6-month intervals up to the 32-month follow-up end point. Two patients with four corresponding fusion levels were lost to follow up. Radiographic evidence of satisfactory fusion was achieved in 42 (95.5%) of 44 levels fused. Satisfactory fusion at all levels was achieved in 23 (92%) of 25 patients. Two patients required repeated operations for treatment of symptomatic pseudarthrosis during the study period. The likelihood of all levels attaining fusion in a given patient decreased as the number of levels treated increased, which is consistent with previously published studies. Nonetheless, fusion rates per treated level were similar for patients in whom one to three levels were treated. No significant surgical complication occurred. CONCLUSIONS: Posterior lumbar interbody fusion in which the HYDROSORB bioabsorbable implant packed with locally harvested autograft and segmental internal fixation are used appears to be an interbody fusion alternative whose efficacy is comparable with previously reported procedures.

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PubMed2003

[Reconstruction of bile duct lesions by an autologous vein graft and a bio-degradable endoluminal stent in an animal model: technique and clinical impact].

INTRODUCTION: In this study a new treatment of bile duct lesions was investigated. A segment of the bile duct was replaced by an autologous venous interponate which had been endoluminally stented with a braided bio-degradable stent. METHODS: A total of 18 pigs (20-28 kg) was divided into three equal groups (I-III). In each group a 2 cm segment of the jugular vein was harvested. The animals in Group I (vein group, n = 6) underwent resection of a 2 cm long segment of the common bile duct which was replaced solely by the venous interponate, in Group II (stent group, n = 6) the venous interponate had been endoluminally stented by a braided bio-degradable stent. Group III (control group, n = 6) underwent only a circular mobilization of the common bile duct. Postoperatively survival rate, general condition as well as the weight were observed and checked for 6 months. During surgery and finally after sacrifice after 6 months blood and tissue samples were taken and semiquantitatively scored concerning grade of inflammation and fibrosis. RESULTS: In the stent and control group all animals survived in good condition. 3 pigs of the vein group died within 3 weeks showing signs of biliary peritonitis, another one died due to a high grade stenosis of the common bile duct with secondary biliary cirrhosis after 4 months. In the stent group all animals survived until sacrifice after 6 months. On examination the venous interponate was laminated with bile duct epithelium showing the diameter of the implanted stent. CONCLUSION: The reconstruction of bile duct lesions by a venous interponate in combination with a bio-degradable stent is easy to perform and represents a clinically interesting alternative to the biliodigestive anastomosis because of the preservation of the sphincter oddi. After 6 months the stent is completely absorbed and the venous interponate is laminated with bile duct epithelium.

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PubMed2003

Long-term study of high-strength hydroxyapatite/poly(L-lactide) composite rods for the internal fixation of bone fractures: a 2-4-year follow-up study in rabbits.

Biodegradation of hydroxyapatite (HA)/poly(L-lactide)(PLLA) composite bone implant rods was studied with the use of two types of HA particles as reinforcing fillers: uncalcined HA (u-HA) or calcined HA (c-HA). Composite rods of u-HA/PLLA and c-HA/PLLA containing 30 or 40% (w/w) HA were implanted in the distal femur of 21 rabbits, and specimens were examined by light microscopy, scanning-electron microscopy (SEM), and transmission-electron microscopy (TEM) 2-4 years later. For u-HA/PLLA, trabecular bone bonding directly onto the rod was maintained for up to 2 years. By 3 years, surface collapse had begun, and the implants were shrinking. By 4 years, they had shrunk further, with complete bone encapsulation. The u-HA particles were small and needle shaped in the peripheries, and TEM confirmed their resorption. The cross-sectional area after 4 years decreased by 23.3+/-8.4%. The mean ratio of bony ingrowth to the initial cross-sectional area around the shrunken rods was 6.7+/-1.3 %. The viscosity molecular weight of PLLA reduced from 2 x 10(5) to less than 1 x 10(3). Thus, most of the PLLA had released from the rods. The c-HA/PLLA implants also showed good osteoconductivity, but shrinkage and infiltration of histiocytes were less. No osteolytic or osteoarthritic changes were found.

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PubMed1998

Tissue response to bioabsorbable self-reinforced polylevolactide and polyglycolide pins implanted intra-articularly and directly into the bone on different levels. An experimental study on rats.

Self-reinforced poly-L-lactide (SR-PLLA) and self-reinforced polyglycolide (SR-PGA) pins were implanted intra-articularly and directly into the bone of the distal femur of rats at three levels: above, on the same level, and under the surface. For the controls only channels were drilled, or the controls were not operated at all. The follow-up times were 3, 6, and 12 weeks for SR-PGA and 3, 6, 12, and 24 weeks for SR-PLLA. The macroscopic appearance and histologically the villus reaction, the mononuclear phagocytosis and giant cells, the neutrophils, the lymphocytes, the plasma cells, the eosinophils, and the mast cells were analyzed. In the histologic analysis, the most favorable implantation depth was found to be under the surface where the contact between the implants and bone was best, and the orifice was covered with new trabecular bone at 3 weeks. This was especially seen in intra-articular implantation. In general, the tissue responses were mild, and could also be explained in the statistical analysis by a normal postoperative tissue response and faster biodegradation of PGA.

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PubMed2006

Accelerated repair of a bone defect with a synthetic biodegradable bone-inducing implant.

BACKGROUND: Nothing has ever had osteoinductive capacity and degradability equivalent to that of autogenous bone, although many types of biomaterials have been developed. To address this issue, we constructed a new bone graft substitute with osteogenic potential and degradability by using porous beta-tricalcium phosphate (beta-TCP) granules, bone morphogenetic protein (BMP), and a synthetic block copolymer composed of poly-D: ,L: -lactic acid with randomly inserted p-dioxanone and polyethylene glycol (PLA-DX-PEG). In this experimental study, the bone-inducing capacity and degradation properties of the composite implant during the bone healing process were examined in vivo in a cortical and cancellous bone defect model in rabbits. METHODS: The advantages of this type of implant have been examined in a cortical bone defect model created in the distal femur of rabbits. The defects (6.5 x 5 mm) were filled with 30 mg of various implants: BMP-H [rhBMP-2, 0.0025% (w/w)], BMP-L [rhBMP-2, 0.000625% (w/w)], control A (beta-TCP alone), and control B (no implant). The distal femurs were harvested at scheduled intervals after surgery and examined for the evaluation of the bony repair of the defects by three-dimensional computed tomography and histology. RESULTS: The repair of both cortical and cancellous bone occurred predominantly in the BMP-H group, and only minor cortical bone repair and cancellous bone formation were noted in the BMP-L and control A groups. Most of the beta-TCP was resorbed in the BMP-H group at 6 weeks after surgery, whereas a significant amount of beta-TCP remained in the BMP-L and control A groups. CONCLUSIONS: beta-TCP granules coated with a BMP-retaining synthetic polymer appear to be effective in enhancing the repair of both cancellous and cortical bone defects. The early disappearance of the implanted beta-TCP and restoration of the normal anatomy of bone tissue are two notable features of this approach.

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PubMed2006

Innovation in multifunctional bioabsorbable osteoconductive drug-releasing hard tissue fixation devices.

We review in this paper the work performed by our group to develop multifunctional bioabsorbable ciprofloxacin releasing bone implants. Poly lactide-co-glycolide (PLGA 80/20 and polylactide (P(L/DL)LA 70/30) were used. Ciprofloxacin (CF) and bioactive glass (BaG) 13-93 were added. The mixture was then extruded and self-reinforced. CF release, mechanical strength, and the effect on S. epidermidis attachment and biofilm formation were evaluated. In rabbits, tissue reactions were assessed. Pull out strength was evaluated in cadaver bones. CF was released over 44 weeks (P(L/DL)LA) and 23-26 weeks (PLGA). Initial shear strength of the CF screws was 152 MPa (P(L/DL)LA) and 172 MPa (PLGA). Strength was retained for 12 weeks (P(L/DL)LA) and 9 weeks (PLGA). Histologically, CF releasing implants did not show much difference from control plain PLGA screws except for increased giant cells. CF miniscrews had lower pullout strength than the controls, but CF tacks had better values than controls. BaG led to a drop in pullout strength properties. Bacterial growth, attachment and biofilm formation on CF implants was significantly reduced when compared to controls. Accordingly, bioabsorbable multifunctional implants with appropriate CF release, mechanical, and biocompatibility properties are possible to develop and are considered appropriate to apply clinically.

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PubMed2006

Morphometrical analysis of multinucleated giant cells in subdermal implants of poly-lactic acid in rats.

The use of bioabsorbable polymers in (bio)medical applications has increased greatly in recent years, mainly because of their good bioreabsorption and biocompatibility. In this work, we examined the development of foreign body giant cells in intimate contact with porous membranes of poly L-lactic acid containing 7% of plasticizer triethylcitrate implanted in the backs of rats. The membranes were removed 2, 7, 14, 21, 28, 60, 90 and 180 days after implantation, along with a portion of the tissue around the implant. Histological analysis of the implant and tissue revealed the formation of a fibrous capsule from the seventh day of implantation onwards. Foreign body giant cells appeared from the seventh day and increased in number up to the twenty-eighth day and then up to the ninetieth day of implantation, remaining constant up to the end of the study onwards, and increased in number up to the ninetieth day after implantation and then remained constant. The number of nuclei in these cells increased from the seventh day of implantation up to the ninetieth day and then up to the end of the study.

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PubMed2003

Multi-pulse drug delivery from a resorbable polymeric microchip device.

Controlled-release drug delivery systems have many applications, including treatments for hormone deficiencies and chronic pain. A biodegradable device that could provide multi-dose drug delivery would be advantageous for long-term treatment of conditions requiring pulsatile drug release. In this work, biodegradable polymeric microchips were fabricated that released four pulses of radiolabelled dextran, human growth hormone or heparin in vitro. Heparin that was released over 142 days retained on average 96 +/- 12% of its bioactivity. The microchips were 1.2 cm in diameter, 480-560 microm thick and had 36 reservoirs that could each be filled with a different chemical. The devices were fabricated from poly(L-lactic acid) and had poly(D,L-lactic-co-glycolic acid) membranes of different molecular masses covering the reservoirs. A drug delivery system can be designed with the potential to release pulses of different drugs at intervals after implantation in a patient by using different molecular masses or materials for the membrane.

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