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PubMed2001

The relationship between structures and in vitro properties of a polyanhydride implant containing gentamicin sulfate.

Laboratory scale injection-molding equipment was utilized to fabricate an implant consisting of poly(FAD:SA 1:1) and 20% (w/w) gentamicin sulfate. Characterizations were performed to determine the molecular weight and glass transition temperature of poly(FAD:SA 1:1). A study was carried out to investigate the relationships between the in vitro performance, morphology, and micro-structures of the molded implants. It was found that implants produced with different structures exhibited different physical integrities in water, i.e., cracking or non-cracking. For the non-cracking implants, a skin-core structure formed by an oriented skin layer was observed under a polarized light microscope. The same morphology was not seen in the cracking implants. The crystal orientation in the skin layer of the non-cracking implants was further identified using a wide-angle x-ray diffraction method (WAXD). No crystal orientation could be found in the cracking implants by WAXD. Furthermore, studies were carried out to evaluate the in vitro drug release for implants showing different degrees of integrity in water. The in vitro drug release of the cracking implants was markedly faster than that of the non-cracking implants due to the pronounced initial drug-burst effect as a result of crack formation in the implants.

Absorbable Implants↗
PubMed2005

Bone repair analysis in a novel biodegradable hydroxyapatite/collagen composite implanted in bone.

The purpose of this study was to evaluate a biodegradable hydroxyapatite/collagen composite and to examine the use of the calcium ion contained for bone formation and growth. Surgical holes were prepared in the femora and tibiae of beagle dogs, and were filled with the hydroxyapatite/collagen composite labeled with alizarin red. After 4 weeks, calcein was administered to the experimental dogs. After 1 additional week, the femora and tibiae were removed surgically and fixed in formalin. Light microscopy and confocal laser scanning microscopy were used to examine the surgical holes with their implanted materials and the surrounding bone. There were only a few inflammatory cells adjacent to the hydroxyapatite/collagen composite. The newly formed bone in the cortical bone was stained with calcein, which binds to serum calcium, and new bone near the hydroxyapatite/collagen composite in the holes was stained positive for alizarin red, which binds to the calcium in the hydroxyapatite/collagen composite. In addition, osteoblasts near the hydroxyapatite/collagen composite as well as newly formed bone adjacent to the osteoblasts showed alizarin red staining, but the new bone at a distance from the hydroxyapatite/collagen implant reacted only to calcein staining. These results, using the tissue labeling method with calcein and alizarin red, suggested that the calcium bound to the alizarin red released from the hydroxyapatite/collagen composite materials might have been translocated to sites of new bone formation. The present experiment showed that the novel hydroxyapatite/collagen composite is a useful implant material for bone augmentation and that the calcium in the newly formed bone might have been released from the implant.

Absorbable Implants↗
PubMedDate not supplied

Repair of radial fractures in toy breed dogs with self-reinforced biodegradable bone plates, metal screws, and light-weight external coaptation.

OBJECTIVE: To describe a surgical technique for, and outcome after, treatment of radial fractures with biodegradable self-reinforced polylactide plates and metal screws, and external coaptation. STUDY DESIGN: Prospective clinical study. SAMPLE POPULATION: Eleven Toy breed dogs. METHODS: Radial fractures were repaired by application of a single or 2 stacked biodegradable self-reinforced polylactide plates (poly-L/D, L-lactide, stereocopolymer [LL-and DL-lactide ratio 70/30]; SR-PLA (70/30) implants) secured with metal screws, and light-weight external coaptation. Healing was evaluated clinically and by radiography at 2, 4, 6, 8, 9, 12, 24-26 weeks, and at 1 and 2 years. Owners were interviewed 3 years after surgery. RESULTS: Radial fracture lines disappeared within 4-14 weeks in 10 dogs; an implant failed in 1 dog. Ambulation was excellent for healed fractures. Excessive skin tension led to removal of implants in 1 dog and suture repair in another dog. No foreign body reaction from implant degradation was observed and the plate was usually no longer palpable at 2 years. One dog had a fracture through a screw hole at 1 year. CONCLUSION: Healing and complication rates after repair of radial fractures with SR-PLA (70/30) plates were considered similar or better than reported after repair with metallic plates or external fixation in Toy breed dogs. No radiographic signs of osteopenia were identified under the plate during follow-up. CLINICAL RELEVANCE: Biodegradable polylactide plates could be considered as an alternative to metal plates for radial fracture repair in Toy breed dogs, however available plates are likely not strong enough when used as a single plate. Implant removal is usually not needed.

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PubMed2002

Osseous regeneration in compromised extraction sites: a ten-year case study.

One of the many problems facing surgeons is finding adequate bone sites for implant support. Without adequate bone, there can be implant failure or poor esthetic results. By using guided tissue regeneration (GTR) membranes and bone grafting materials, implants may be placed into immediate extraction sites and areas with large osseous defects with an expectation of long-term positive results. These concepts are illustrated by comparing the results of a ten-year follow-up evaluation of a patient lacking healthy bone at the implant site with another case in which the implant site had bone of acceptable morphology and density, with both cases showing similarly good results.

Absorbable Implants↗
PubMed1998

Localized ridge augmentation with chin grafts and resorbable pins: case reports.

Six block grafts harvested from the mandibular symphysis were used to augment partially atrophied ridges. Three maxillary defects and three mandibular defects were treated in five patients. Autologous bone grafts from the chin were stabilized in the recipient sites with resorbable pins and no membranes were used over the grafts. Healing proceeded without complications. At 3 to 4 months the external cortical surface of the grafts progressively resorbed and the profiles of the pins protruded from underneath the buccal tissue that covered the augmented areas. However, the pins never perforated the tissue and they were resorbed macroscopically within 4 to 6 months. At 6 months the areas treated showed successful ridge augmentation and when exposed for stage 2 surgery, remnants of the pin holes on the external surface of the repaired defects were detected. Radiographic evaluation of the block grafts was performed at 3 and 6 months and histologic specimens were obtained at 6 months; the specimens demonstrated incomplete pin resorption and encapsulation. A severe foreign-body reaction was detected in one case. The presence of an acellular bone matrix in certain sections and a normal bone pattern with a cellular component in others was a consistant finding. ITI endosseous Implants were placed with excellent primary stability in all treated cases.

Absorbable Implants↗
PubMed2000

Histomorphometric study on high-strength hydroxyapatite/poly(L-lactide) composite rods for internal fixation of bone fractures.

The purpose of this study was to investigate the bone-implant interface of high-strength hydroxyapatite (HA)/poly(L-lactide) (PLLA) composite rods. As reinforcing particles, two types of HA particles-calcined HA (c-HA) and uncalcined HA (u-HA)-were applied to allow comparison of their suitability as bioactive fillers. Four types of composites (c-HA30, c-HA40, u-HA30, and u-HA40), which contained 30 or 40% by weight of each HA particle, were used. Unfilled PLLA rods were used as controls. A hole was drilled in the distal femora of 50 rabbits, and a composite or unfilled PLLA rod was implanted in a press-fit manner. Two, 4, 8, and 25 weeks after implantation, the samples were examined histologically by light microscopy, scanning electron microscopy (SEM), and transmission electron microscopy (TEM). An image analyzer was used for histomorphometric analysis of the bone-implant interface. An affinity index was calculated for each material; this was the length of bone directly apposed to the rods expressed as a percentage of the total length of the rod surface. In all the composites, histologic examination showed new bone formation at 2 weeks after implantation. The bone gradually grew along the composite surface. SEM showed direct bone contact with the composites without intervening fibrous tissue. During follow-up, the affinity indices of all the composite rods were significantly higher than those of the unfilled PLLA rods (p < 0.01; two-way ANOVA). The maximum affinity index (41%) was attained at 4 weeks in c-HA40 rods. In contrast, little bone contact was seen in unfilled PLLA rods. The only significant difference in affinity indices among the composites was that c-HA40 had a higher affinity index than u-HA40 (p < 0.05 at 4 weeks). No disintegration of rods or polymer debris, which could elicit inflammatory tissue reactions, was observed even at 25 weeks. Our results indicate that osteoconductive bone formation on composites could enhance the stability between bone and implant in fracture repair.

Absorbable Implants↗
PubMed2001

Bone bonding in sintered hydroxyapatite combined with a new synthesized agent, TAK-778.

We studied the stimulatory effects of TAK-778, a new synthetic 3-benzothiepin derivative that promotes osteoblast differentiation, in bone bonding to sintered hydroxyapatite implants in rabbit tibiae. Smooth-surfaced rectangular plates (15 x 10 x 2 mm) made of sintered hydroxyapatite were implanted into the proximal metaphyses of bilateral rabbit tibiae, with TAK-778-containing sustained-release microcapsules packed into the medullary cavity in one limb and untreated microcapsules packed in the contralateral limb to serve as a paired control. At 4, 8, and 16 weeks after implantation, bone bonding at the bone-implant interfaces was evaluated by a detaching test and undecalcified histological examination. The tensile failure load increased from 4 to 16 weeks for both groups; however, the tensile failure load of the TAK-778-treated group was significantly greater than that of the control group at each interval after implantation. Histologically, the TAK-778-treated specimens showed greater active new bone formation mainly in the medullary cavity and more extensive bonding between the implant and bone than the untreated specimens. The results of this study suggest that adding osteoinductive TAK-778 to hydroxyapatite implants may significantly accelerate bone apposition to the implants and improve the bonding process at the interface. This would help to establish an earlier and stronger bonding of orthopedic ceramic implants between the surrounding bone tissue.

Absorbable Implants↗
PubMed2006

Is a collagen scaffold for a tissue engineered nucleus replacement capable of restoring disc height and stability in an animal model?

The idea of a tissue engineered nucleus implant is to seed cells in a three-dimensional collagen matrix. This matrix may serve as a scaffold for a tissue engineered nucleus implant. The aim of this study was to investigate whether implantation of the collagen matrix into a spinal segment after nucleotomy is able to restore disc height and flexibility. The implant basically consists of condensed collagen type-I matrix. For clinical use, this matrix will be used for reinforcing and supporting the culturing of nucleus cells. In experiments, matrixes were concentrated with barium sulfate for X-ray purposes and cell seeding was disclaimed in order to evaluate the biomechanical performance of the collagen material. Six bovine lumbar functional spinal units, aging between 5 and 6 months, were used for the biomechanical in-vitro test. In each specimen, an oblique incision was performed, the nucleus was removed and replaced by a collagen-type-I matrix. Specimens were mounted in a custom-built spine tester, and subsequently exposed to pure moments of 7.5 Nm to move within the three anatomical planes. Each tested stage (intact, nucleotomy and implanted) was evaluated for range of motion, neutral zone and change in disc height. Removal of the nucleus significantly reduced disc height by 0.84 mm in respect to the intact stage and caused an instability in the segment. Through the implantation of the tissue engineered nucleus it was possible to restore this height and stability loss, and even to increase slightly the disc height of 0.07 mm compared with the intact stage. There was no statistical difference between the stability provided by the implant and intact stage. Results of movements in lateral bending and axial rotation showed the same trend compared to flexion/extension. However, implant extrusions have been observed in three of six cases during the flexibility assessment. The results of this study directly reflect the efficacy of vital nucleus replacement to restore disc height and to provide stability to intervertebral discs. However, from a biomechanical point of view, the challenge is to employ an appropriate annulus fibrosus sealing method, which is capable to keep the nucleus implant in place over a long-time period. Securing the nucleus implant inside the disc is one of the most important biomechanical prerequisites if such a tissue engineered implant shall have a chance for clinical application.

Absorbable Implants↗
PubMed2006

Study of biodegradable and self-expandable PLLA helical biliary stent in vivo and in vitro.

Biodegradable stents have advantages for the treatment of benign and malignant biliary stricture, especially eliminating the need for stent removal. In our present work, helical poly-l-lactic acids (PLLA) stent was fabricated and evaluated in vivo and in vitro. For in vivo study, bile duct injury canine models were made by transection of common bile ducts. Duct to duct anastomosis was done with helical PLLA biodegradable stents. Scanning electron microscopy (SEM) and histopathology were performed after three months. For In vitro study, sludge attachment assessment was performed. Polyethylene (PE) and PLLA membranes were immersed in human bile for two months. The samples were taken out and characterized by SEM. Self-expanding property of the helical stent was tested in 37 degrees Celsius water. The results demonstrate that the biodegradable stent had not only good biocompatibility, but also self-clearing effect to clear the attached sludge away. The self-expanding property facilitated stent implantation and also suggested possibility to be implanted endoscopically.

Absorbable Implants↗
PubMed2004

Self-reinforced bioabsorbable miniplates for skeletal fixation in complex hand injury: three case reports.

We report our preliminary experience with 3 cases in which internal fixation with a self-reinforced poly-l/dl-lactide 70/30 miniplate and 1.5-mm or 2.0-mm screws were used to stabilize an open metacarpal fracture, a metacarpophalangeal arthrodesis in a thumb replantation, and an interposed bone graft for reconstruction of a thumb. Clinical and radiologic follow-up evaluation lasted for 12 to 20 months. Bone healing was uneventful in all 3 cases with no displacement or delayed union. The implants were biocompatible with no clinically manifested foreign body reaction. Because of the self-reinforcing manufacturing technique the plates have metal-like mechanical and handling properties. Complete late resorption makes self-reinforced poly-l/dl-lactide 70/30 miniplating systems an attractive alternative to metallic implants for skeletal stabilization of small bones of the hand.

Absorbable Implants↗
PubMed2004

Use of bioabsorbable osteofixation devices in the hand.

Bioabsorbable internal fixation by means of pins, tacks, screws and miniplates offers an alternative to metallic osteofixation for the stabilization of small bone fractures, osteotomies, ligament injuries and fusions in the hand. The advantages of using them include avoidance of metallic-implant-related long-term complications and a secondary removal operation. Currently the most commonly used devices are made of poly L-lactide (PLLA) and copolymers of polylactides (P(L/DL)LA) and polyglycolide (PLGA). In areas of mechanical stress, the use of ultra-high-strength self-reinforced devices is recommended. Biomechanical studies on fresh frozen bones have shown that the fixation rigidity achieved with self-reinforced devices approaches that of metallic osteofixation methods. The reliability of modern implants has been confirmed in several experimental and clinical studies.

Absorbable Implants↗
PubMed2001

Pitfalls associated with fixation of osteochondritis dissecans fragments using bioabsorbable screws.

The purpose of this study was to evaluate 2 cases in which bioabsorbable screw fixation for an osteochondritis dissecans lesion of the femoral condyle resulted in complications necessitating the need for secondary surgery. We reviewed the case history of these patients and described the circumstances under which the bioabsorbable screws were used, the events leading to the need for secondary surgery, and the ultimate outcome. In the 2 cases presented, these implants were found to retain their mechanical stiffness for many months. This resulted in articular damage in 1 case after the treated lesion failed to heal. In the second case, screw breakage 8 months after implantation resulted in it becoming a loose body, which required removal during a second arthroscopic procedure. We conclude that these implants retain their mechanical properties for many months and cannot be relied on to degrade quickly. If a treated lesion fails to heal, these implants can cause mechanical problems due to their retained structural properties.

Absorbable Implants↗
PubMed2002

Study by finite element method of the mechanical stress of selected biodegradable osteosynthesis screws in sagittal ramus osteotomy.

We tested the stability of the bilateral sagittal split osteotomy using four resorbable osteosynthesis screws (the PLLA screw introduced by Harada and Enomoto, the Isosorb screw, the BioSorbFX screw and the Lactosorb screw) which are all currently in clinical use. The distribution of stress in both the bicortically inserted screws and the adjacent bone of a computer-generated mandible was recorded by the three-dimensional finite element method. The stress of the materials under investigation was postulated to have reached threshold values for stability, and maximum chewing forces of 132 N (Harada and Enomoto), 117 N (Isosorb), 115 N (BioSorbFX) and 46.4 N (Lactosorb) were determined. As far as the postoperative chewing forces were concerned, all four screws were sufficiently stable at the osteotomy gap. Finite element modelling seems to be an appropriate method of investigating these clinical issues when the mechanical stress both in implants and in the adjacent bone is taken into account.

Absorbable Implants↗
PubMed2004

Long-term results with different bone substitutes used for sinus floor elevation.

One of the surgical procedures preceding implantation is elevation of the base of the maxillary sinus. Numerous bone substituting materials (grafts) may be used for this purpose, including autogenous bone, heterografts, xenogenous bone, and synthetic materials alone or in combination or mixed with growth factors and bone morphogenetic protein (BMP) preparations. A study of the frequencies of the failures (graft material resorption or implant loss) after sinus elevations with various graft materials or their combinations was conducted. In the 5-year period from 1996 through 2001, a follow-up investigation of 810 maxillary sinus augmentations was performed, in which the sinus elevations involved the use of autogenous bone, a calcium carbonate-coated polymer, hydroxylapatite of algal origin, calcium carbonate gel produced from coral or beta-tricalcium phosphate alone, autogenous bone mixed with these bone substitutes, or a combination of beta-tricalcium phosphate and platelet-rich plasma. The incidences of graft resorption and implant loss after the augmentations with various bone substitutes were recorded. Total resorption (disappearance) of the bone substitute material was observed in 2.7% of the cases. An essential difference was not experienced between the various bone substitutes from this aspect, with the exception of the gel-state calcium carbonate, where 40% of the grafts were resorbed. In total, 5.46% of the implants were lost; the differences between the various materials were not significant.

Absorbable Implants↗
PubMed2005

Histologic analysis of bioabsorbable scleral buckling implants: an experimental study on rabbits.

PURPOSE: To analyze histologically tissue reactions to bioabsorbable PLA96 in rabbit eyes. METHODS: Scleral buckling operations were carried out in 48 rabbits. Two materials were used: bioabsorbable PLA96 (polylactide 96/4; L/D molar ratio 96/4) and silicone sponge. One eye of each rabbit was operated on and the other eye served as a nonoperated control. After follow-up times of 1, 3, 5, and 12 months, the rabbits were killed and the eyes enucleated for histology. RESULTS: All rabbits recovered well. Histologically, tissue reactions were very localized; implant fragments were not seen within the sclera. The amounts of fibrous tissue and inflammatory cells (mainly macrophages) inside the implant area increased over time. One rabbit from the silicone group was killed 4 months postoperatively owing to refusal to eat. In the PLA96 group, acute or chronic infections occurred in four rabbits. The bioabsorbable implant was macroscopically easily detectable at 12 months postoperatively. CONCLUSIONS: The PLA96 material used for scleral buckling in rabbits showed good biocompatibility. The material did not undergo biodegradation during the follow-up period of 12 months. PLA96 implants were associated with thicker fibrous tissue encapsulation and more inflammatory cells compared with silicone sponge implants.

Absorbable Implants↗
PubMed2006

Clinical experience with a new fast-resorbing polymer for bone stabilization in craniofacial surgery.

Polylactic acid (PLA) and polyglycolic acid have been successfully used as suture material during the past 30 years and have been successfully used in various orthopedic and craniofacial applications, with increasing frequency during the past 15 years. To eliminate some of the problems seen with the longer-lasting Macropore PLA product and other longer-lasting resorbable systems, a new fast-resorbing polymer (FRP) was manufactured by Macropore-Medtronic Neurologic Technologies, Inc. from commercially available 85:15 poly(D,L-lactide-co-glycolide) raw material using traditional melt-processing techniques. The delivery system is easily used and uses essentially the same instrumentation. One hundred and sixty eight patients who had implantation of the FRP were studied. Detailed clinical evaluation was completed after surgery and at each postoperative visit. Overall, there was a 2.1% implant-related complication rate, which compared favorably to the 8.5% implant-related complication rate associated with the longer-lasting PLA product. All patients who received FRP implants have had maintenance of stable bony fixation, followed by bony healing and satisfactory or excellent cosmetic results. The results from the FRP study indicate that the FRP material and implants are safe and effective in craniomaxillofacial applications.

Absorbable Implants↗
PubMed2001

Bioabsorbable materials for guided bone regeneration prior to implant placement and 7-year follow-up: report of 14 cases.

BACKGROUND: The purpose of the present study was to evaluate the efficacy of a guided bone regeneration (GBR) procedure prior to implant placement and the long-term outcome of the inserted implants. METHODS: Prior to dental implant placement, GBR procedure was performed on 14 patients (mean age 48 years) using a synthetic hydroxyapatite (HA) spacer under a collagen membrane. After a mean healing period of 8 months, bone biopsies were obtained during the placement of 14 implants. The specimens were processed for histology without demineralization in order to assess bone quality and quantity of the regenerated bone. RESULTS: Both the bone density and the resorption degree of HA particles were relatively varied between samples. The different phenotypes of osteoclasts and multinucleated giant cells and the individual host response could partially explain the unpredictable results in terms of bone remodeling and biomaterial resorption. However, the presence of HA particles in the regenerated bone had no influence on the osseointegration of implants presenting a success rate of 86% after a 7-year observation period. CONCLUSIONS: These results confirm the possibility of regenerating bone by means of bioabsorbable materials, assuring at the same time the long-term success for implants inserted in regenerated sites.

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