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PubMed2004

Bioabsorbable implants: review of clinical experience in orthopedic surgery.

Bioabsorbable implants are widely used in orthopedic surgery today and the worldwide market is expanding rapidly. Despite the popularity of these implants, reports of complications continue to appear in the literature. Although the complications rarely have an adverse affect on long-term outcomes, the reports are too numerous to be mere isolated incidents related to one specific implant. Complications have been reported with most of the commercially available implant materials with varying incidence rates and severities of reactions to the implants. The purpose of this review is to summarize the adverse events that have been reported in clinical trials of bioabsorbable implants in orthopedic surgery.

Absorbable Implants↗
PubMed1997

Degradation characteristics of PLLA-PGA bone fixation devices.

Parietal craniotomies of the mature rabbit skull were repositioned and fixed with resorbable plate and screws made of LactoSorb (Walter Lorenz Surgical, Jacksonville, FL) poly L-lactic acid (PLLA) and polyglycolic acid (PGA) in 20 mature rabbits. Changes in the resorbable devices as well as at the tissue-implant interface were evaluated at 2, 6, 9, and 12 months postoperatively. At 2 months, no change in the size of the implants was seen with a noninflammatory layer of surrounding fibrous tissue and intense birefringence of the screws. At 6 months, substantial loss of implant size had occurred, accompanied by fibrovascular and a macrophage cellular infiltrate. At 9 months, more than 95% of the implant was resorbed, with a small amount remaining in the screw hole. Other than macrophages within the remaining material, very few giant cells were seen. By 1 year, no evidence of birefringent macromolecular polymer debris could be found. No contraindications for the clinical use of this specific PLLA-PGA copolyer could be found when implanted on craniofacial bone surface.

Absorbable Implants↗
PubMed2002

Bioabsorbable poly-L-lactic acid cages for lumbar interbody fusion: three-year follow-up radiographic, histologic, and histomorphometric analysis in goats.

STUDY DESIGN: Long-term evaluation was performed for bioabsorbable poly-L-lactic acid cages in a goat interbody fusion model. OBJECTIVE: To assess the radiographic, histologic, and histomorphometric characteristics of poly-L-lactic acid cages during 3 years of follow-up evaluation. SUMMARY OF BACKGROUND DATA: Failed cage fusions may be related to cage design and material in addition to the surgical technique used. To overcome material-related complications and to explore the potential benefits of bioabsorbable cages, poly-L-lactic acid cages have been designed. METHODS: For this study, 36 Dutch milk goats underwent a lumbar interbody fusion procedure (L3-L4). Two types of custom-made cage devices were impacted with bone graft and implanted: poly-L-lactic acid cages (n = 30) and titanium cages (n = 6). Sequential harvesting of surgically managed motion segments (intervals: 3, 6, 12, 24, and 36 months) was performed for analysis. RESULTS: In poly-L-lactic acid specimens, permanent interbody fusion could be achieved within 6 months after surgery with maintenance of cage height. Titanium specimens showed no interbody fusion within this period. Radiographic follow-up evaluation (6-36 months) showed interbody fusion in 86% (19/22) of poly-L-lactic acid specimens, as compared with 33% (2/6) of titanium specimens. After 36 months of implantation, in one half of the specimens, poly-L-lactic acid cages were completely absorbed. Bone histomorphometry showed complete bone remodeling after 2 years of follow-up evaluation. During the study period, no local or distant adverse histologic effects were observed. CONCLUSIONS: The current study showed that poly-L-lactic acid cage devices are feasible for lumbar interbody fusion. New poly-L-lactic acid cages designed for clinical practice might be a viable alternative to current nonabsorbable cage devices.

Absorbable Implants↗
PubMed1976

Scleral buckling with Bioplast fibrin in retinal detachment.

The study includes a series of 38 patients with retinal detachment of different aetiology. Scleral reduction combined with the intrascleral implantation of absorbable Bioplast fibrin scleral buckling rods was performed and reattachment achieved in 31 cases. The implant material is biocompatible and is eliminated from the eye in the course of a few weeks.

Adolescent↗
PubMed2002

A synthetic bioactive resorbable graft for predictable implant reconstruction: part one.

Animal studies were conducted to evaluate the cell response and chemical potentiality of a synthetic bioactive resorbable graft (SBRG) made of nonceramic cluster particulate of low-temperature HA material. The study evaluated bone-bridging of the SBRG particulates in 1-mm wide implant channels of 5 x 8 mm long roughened titanium interface in 6 dogs and compared results to the same implant channels left empty as controls at 6- and 12-week intervals. Resorption rate capacity and cell response were evaluated with an assessment of the chemical characterization of the synthetic nonceramic material next to the titanium implant interfaces. Results of the animal studies were compared with human histologic biopsies of the SBRG for bone quality, density, and bone growth into defect sites concurrent with resorption time of the graft. One human biopsy consisted of a graft mixture of the SBRG and dense bovine-derived HA, compared under the electron microscope, including histology by H and E staining. Part 1 of this paper presents evidence of the predictability and efficacy of the SBRG osteoconductive, particulate chemical potentiality to aid in the regeneration of lost bone anatomy next to titanium implant interfaces. Recent technological innovations in computer hardware and software have given clinicians the tools to determine 3-dimensional quality and density of bone, including anatomical discrepancies, which can aid in the diagnosis and treatment planning for grafting procedures. When teeth are extracted, the surrounding bone and soft tissue are challenged as a result of the natural resorptive process. The diminished structural foundation for prosthetic reconstruction, with or without implants, can be compromised. A synthetic bioactive resorbable graft material having osteoconductive biochemical and biomechanical qualities similar to the host bone provides the means to improve compromised bone topography for ridge preservation, ridge augmentation, or to enhance the bony site for implant placement and subsequent prosthetic rehabilitation. Part two of this paper will demonstrate clinical applications of the SBRG material for purposes of implant placement and prosthetic reconstruction.

Absorbable Implants↗
PubMed2001

Histopathological morphometric evaluation of 2 different hydroxyapatite-bone derivatives in sinus augmentation procedures: a comparative study in humans.

BACKGROUND: Xenografts to augment the maxillary sinus have been used extensively. The aim of the present study was to evaluate, qualitatively and quantitatively, two different HA derivatives of natural and synthetic sources on newly formed bone in the augmented sinus. METHODS: A bilateral sinus augmentation procedure with simultaneous (16 out of 20 sites) or subsequent implant placement was performed in 10 patients. The antrum was randomly filled with a deproteinized, bovine hydroxyapatite mineral (B-HA) on one side and a non-ceramic resorbable hydroxyapatite (NC-HA) on the other. Cylindrical specimens were harvested from the augmented core at 12 months. Decalcified specimens were sectioned at a cross-horizontal plane and stained with hematoxylin and eosin for histopathologic and histomorphometric examinations. Tissue area fractions of bone, marrow, and the grafted particles were calculated for each specimen from the lateral to the deep region, and changes in values were compared within each material and between them. RESULTS: New bone formation was evident. B-HA and NC-HA particles were observed in all specimens surrounded by newly formed bone in direct connection or by soft tissue marrow. Morphometrically in the B-HA sites, from the lateral to deeper area, bone area fraction increased from 29.8% to 54.2% (average 42.1%) and marrow area fraction decreased from 37.9% to 26.7% (average 33.3%). The mineral area fraction decreased from 32.3% to 19.1% (average 24.7%). All increasing/decreasing patterns were statistically significant (P < 0.001). In the NC-HA sites, from the lateral to deeper area, bone area fraction increased from 25% to 36.5% (average 32.3%) and marrow area fraction decreased from 51.6% to 41.9% (average 43.2%) (P <0.001). The mineral area fraction decreased from 29% to 21.7% (average 24.6%) (P = 0.038). Comparison between the two HA derivative groups showed a significant difference between the bone area fraction averages (P = 0.0053) and between the increasing patterns along the core depth (P = 0.0006). There was also a significant difference between the decreasing marrow patterns (P = 0.003), but not between their averages. Comparison between the mineral area fractions showed no differences. CONCLUSIONS: B-HA and NC-HA were proven to be biocompatible materials. Although the B-HA-augmented sites showed a higher percentage of bone formation at 12 months, both are suitable bone derivatives in sinus augmentation procedures and can accommodate osseointegrated implants.

Absorbable Implants↗
PubMed2001

Development of a model for bioresorbability of bioceramic microparticles.

Over the past decade, numerous studies have implicated wear particle debris, generated by everyday wear or ceramic implants, as the essential contributors to implant failure [3,4,5,6,7]. We investigated the interactions of ceramic particles (TCP and HA) on cell viability, cell damage, and respiratory burst in a macrophage cell line (RAW 264.7) for a duration of 24, 48, and 72 hours. The results show that cellular protein levels ranged between 0.20-0.3 mg/ml for the duration of the experiment, and there was no difference detected between or among the groups (P < 0.05). Differences in MDA levels (the amount of lipid peroxides formed at the cellular membrane) were not detected at the early time points (24-48 hours). However, with time in culture there is an increase in MDA levels in all groups. There were no differences detected in nitric oxide production between TCP and the control at all phases. The amount of nitric oxide produced by cells treated with Ha decreased slightly at 24 hours. In contrast, at 48 and 72 hours there was a significant increase when compared to the control. Morphological evaluation revealed that cells treated with TCP contained irregular membrane boundaries, and appeared to have cytoplasmic extensions. Many of the macrophages consisted of large vacuoles containing TCP particles. Cells treated with HA also contained irregular cytoplasmic borders with an increase in vacuolization. At 48 hours, the morphology of all groups remained the same, and at 72 hours, many of the cells treated with TCP and HA began to lyse. Overall, RAW 264.7 macrophage cells are capable of ingesting particles of TCP and HA, and after three days in culture the cells begin to show the effects of increased retention of ceramic particles. The results of this investigation can be used as a model for the assessment of the resorbability rate of implantable devices.

Absorbable Implants↗
PubMed2005

Clinical case reports of injectable tissue-engineered bone for alveolar augmentation with simultaneous implant placement.

This clinical study was undertaken to evaluate the use of tissue-engineered bone, mesenchymal stem cells, platelet-rich plasma, and beta-tricalcium phosphate as grafting materials for maxillary sinus floor augmentation or onlay plasty with simultaneous implant placement in six patients with 3- to 5-mm alveolar crestal bone height. All 20 implants were clinically stable at second-stage surgery and 12 months postloading. A mean increase in mineralized tissue height of 7.3+/-4.6 mm was evident when comparing the pre- and postsurgical radiographs. Injectable tissue-engineered bone provided stable and predictable results in terms of implant success.

Absorbable Implants↗
PubMed1992

The tissue-implant interface during degradation of absorbable polyglycolide fracture fixation screws in the rabbit femur.

A transverse transcondylar osteotomy of the distal femur was fixed with an axially placed absorbable fracture fixation screw made of polyglycolide (PGA) in 25 rabbits. Changes at the tissue-implant interface accompanying degradation of the screw were examined histologically, histomorphometrically, and microradiographically seven, 20, 40, 80, and 250 days after implantation. At seven days postimplantation, a layer of fibroblasts was seen surrounding the implant, and new bone formation was discernible in the host tissues adjacent to this membranous structure. At 20 days postimplantation, the geometry of the screw was still intact and the tissue-implant boundary was distinct. The first signs of invasion of vascular granulation tissue into the implant were observed 40 days after implantation, at which time the osteotomies were united. The apparent walling-off response by formation of new trabecular bone outlining the PGA profile continued, with the greatest mean trabecular bone volume fraction at the interface, 23.9%, measured at 40 days. A significant decrease in the new bone volume occurred between 40 and 80 days postimplantation. The intensity of the foreign-body reaction seen was histologically moderate. The giant cell count was highest at 80 days postimplantation, when the migratory activity of phagocytic cells had transported intracellular particulate polymeric debris 400-800 microns away from the original tissue-implant boundary. At 250 days postimplantation, no birefringent polymeric material could be seen in the specimens. No contraindications for the clinical application of PGA implants emerged in this study.

Animals↗
PubMed2003

Space-providing expanded polytetrafluoroethylene devices define alveolar augmentation at dental implants induced by recombinant human bone morphogenetic protein 2 in an absorbable collagen sponge carrier.

BACKGROUND: Surgical implantation of recombinant human bone morphogenetic protein 2 (rhBMP-2) in an absorbable collagen sponge carrier (ACS) significantly enhances bone regeneration in horizontal alveolar defects; however, sufficient quantities of bone for implant dentistry are not routinely obtained. PURPOSE: The objective of this proof-of-principle study was to evaluate the potential of a space-providing macroporous expanded polytetrafluoroethylene (ePTFE) device to control volume and geometry of rhBMP-2/ACS-induced alveolar bone augmentation. MATERIALS AND METHODS: Bilateral critical-size supra-alveolar periimplant defects were created in four Hound-Labrador mongrel dogs. Two turned and one surface-etched 10 mm titanium dental implants were placed 5 mm into the surgically reduced alveolar ridge creating 5 mm supra-alveolar defects. rhBMP-2/ACS (0.4 mg rhBMP-2) was placed around the exposed dental implants. Additionally, one jaw quadrant in each animal was randomly assigned to receive the dome-shaped macroporous ePTFE device. Mucoperiosteal flaps were advanced for primary wound closure. The animals were euthanized at 8 weeks post surgery for histometric analysis. RESULTS: The space-providing macroporous ePTFE device defined the volume and geometry of rhBMP-2/ACS-induced bone formation, whereas bone formation at sites receiving rhBMP-2/ACS alone varied considerably. Vertical bone gain at turned dental implants averaged (+/-SD) 4.7 +/-0.2 mm at sites receiving rhBMP-2/ACS and the ePTFE device compared with 3.5 +/-0.9 mm at sites receiving rhBMP-2/ACS only. The corresponding values for rhBMP-2/ACS-induced bone area were 9.6 +/- 0.7 mm2 and 7.5 +/-6.2 mm2. There was a highly significant correlation between induced bone area and the space provided by the ePTFE device (p <.001). There was no difference in induced bone density or bone-implant contact between the two technologies. These observations were consistent with those observed at surface-etched dental implants. CONCLUSIONS: The data from this study suggest that a space-providing macroporous ePTFE device defines rhBMP-2/ACS-induced alveolar augmentation to provide adequate bone quantities for implant dentistry. The dental implant surface technology does not appear to substantially influence bone formation.

Absorbable Implants↗
PubMed2004

Changes in macrophage function and morphology due to biomedical polyurethane surfaces undergoing biodegradation.

Monocytes are recruited to the material surface of an implanted biomedical device recognizing it as a foreign body. Differentiation into macrophages subsequently occurs followed by fusion to form foreign body giant cells (FBGCs). Consequently, implants can become degraded, cause chronic inflammation or become isolated by fibrous encapsulation. In this study, a relationship between material surface chemistry and the FBGC response was demonstrated by seeding mature monocyte-derived macrophages (MDMs) on polycarbonate-based polyurethanes that differed in their chemical structures (synthesized with poly(1,6-hexyl 1,2-ethyl carbonate) diol, and either (14)C-hexane diisocyanate and butanediol (BD) (referred to as HDI) or 4,4'-methylene bisphenyl diisocyanate and (14)C-BD (referred to as MDI)) and material degradation assessed. At 48 h of cell-material interaction, the FBGC attached to HDI were more multinucleated (73%) compared to MDI or the polystyrene (PS) control (21 and 36%, respectively). There was a fivefold increase in the synthesis and secretion of a protein with an approximate molecular weight of 48 kDa and a pI of 6.1 (determined by two-dimensional gel electrophoresis) only from cells seeded on HDI. Immunoprecipitation confirmed that MSE and CE were synthesized and secreted de novo. Immunoblotting also showed an increase in secreted monocyte-specific esterase (MSE) and cholesterol esterase (CE) from cells seeded on HDI relative to PS and MDI. Significantly more radiolabel ((14)C) release and esterase activity were elicited by MDMs on HDI than MDI (P < 0.05). The material that was more degradable (HDI), elicited greater protein synthesis and esterase secretion as well as more multinucleated MDMs than MDI, suggesting that the material surface chemistry modulates the function of MDM at the site of an inflammatory response to an implanted device.

Absorbable Implants↗
PubMed2005

The bone response of oxidized bioactive and non-bioactive titanium implants.

A number of experimental and clinical data on so-called oxidized implants have reported promising outcomes. However, little is investigated on the role of the surface oxide properties and osseointegration mechanism of the oxidized implant. Sul [On the Bone Response to Oxidized Titanium Implants: The role of microporous structure and chemical composition of the surface oxide in enhanced osseointegration (thesis). Göteborg: Department of Biomaterials/Handicap Research, University of Göteborg, Sweden; 2002; Biomaterials 2003; 24: 3893-3907] recently proposed two action mechanisms of osseointegration of oxidized implants, i.e. mechanical interlocking through bone growth in pores/other surface irregularities (1) and biochemical bonding (2). The aim of the present study is two-fold: (i) investigating the role of the implant surface chemistry on bone responses; (ii) investigating the validity of the biochemical bonding theory of the oxidized, bioactive bone implants with specific implant surface chemistry. Two groups of oxidized implants were prepared using micro arc oxidation process and were then inserted in rabbit bone. One group consisted of magnesium ion incorporated implants (MgTiO implant), the other consisted of TiO2 stoichiometry implants (TiO implant). Surface oxide properties of the implants were characterized with various surface analytic techniques. After 6 weeks of follow up, the mean peak values of removal torque of Mg implants dominated significantly over TiO implants (p < or = 0.0001). Bonding failure generally occurred in the bone away from the bone to implant interface for the MgTiO implant and mainly occurred at the bone to implant interface for the TiO implant that consisted mainly of TiO2 chemistry and significantly rougher surface as compared to the MgTiO implant. Between bone and the Mg- incorporated implant surface, ionic movements and ion concentrations gradient were detected. The current in vivo experimental data may provide positive evidence for the surface chemistry-mediated biochemical bonding theory of oxidized bioactive implants. However, the present study does not rule out potential synergy effects of the oxide thickness, micro-porous structure, crystal structure and surface roughness on improvements of bone responses to oxidized bioactive implants.

Absorbable Implants↗
PubMed2003

Microfabricated drug delivery systems: from particles to pores.

Microfabrication techniques which permit the creation of therapeutic delivery systems that possess a combination of structural, mechanical, and perhaps electronic features may surmount challenges associated with conventional delivery of therapy. In this review, delivery concepts are presented which capitalize on the strengths of microfabrication. Possible applications include micromachined silicon membranes to create implantable biocapsules for the immunoisolation of pancreatic islet cells-as a possible treatment for diabetes-and sustained release of injectable drugs needed over long time periods. Asymmetrical, drug-loaded microfabricated particles with specific ligands linked to the surface are proposed for improving oral bioavailability of peptide (and perhaps protein) drugs. In addition, microfabricated drug delivery systems ranging from transdermal microneedles to implantable microchips will be discussed.

Absorbable Implants↗
PubMed2001

Intraindividual comparative animal study of alpha- and beta-tricalcium phosphate degradation in conjunction with simultaneous insertion of dental implants.

An intraindividual comparative study of proximal tibial marrow defects in nine adult Goettinger miniature pigs (GMPs) was undertaken. The left side of the defect was filled with granular beta-tricalcium phosphate (TCP) ceramic ad modum Cerasorb, and the right side was filled with granular alpha-TCP ceramic ad modum Biobase alpha pore. Simultaneously, dental screw implants were inserted in each ceramic and fixed within the orthotopically replanted corticalis lids. Control defects were made in two other animals. The survival period ranged from 4 to 86 weeks (control study, 16 and 20 weeks). The reorganization and degree of bone regeneration, dynamics of ceramic degradation, and remodeling characteristics of the bone regenerate referring to osseo-integration of the dental implants were examined histomorphologically in nondecalcified specimens. The results reveal that both ceramic types were osteoconductive exclusively. Centripetally oriented angiogene bone regeneration occurred at the margins of the circular defects. Ceramic degradation was performed hydrolytically and within cells. Furthermore, it was demonstrated that decomposition of the intratrabecularly integrated ceramic residues underlies a dynamic process of degradation. Within 86 weeks, nearly 80% to 90% of the larger alpha-TCP granules, and nearly 90% to 95% of the beta-TCP granules were degraded. At this time, especially for the alpha-TCP modification, ceramic microparticles were found in the marrow, either unbound or within polynuclear macrophages. The predictable degradation of both ceramic types provides an early functional adaptation of bone regenerates and facilitates a biofunctional, anisotropic orientation of the neotrabeculae without delay. It is concluded that because of the initially pronounced accumulation of macrophages, dental implants should not be inserted simultaneously with ceramic, but after further progress of ceramic degradation (5 to 6 months after TCP implantation).

Absorbable Implants↗
PubMed1998

The use of a new allograft material for osseous reconstruction associated with dental implants.

This article introduces the use of a new bone graft material. The material is a human collagen allograft resorbable matrix impregnated with demineralized freeze-dried bone granules. This material is harvested from the same donor. A series of three cases of extractions with immediate implant placement accompanied by osseous defects were used to demonstrate the use of this material. Bone cores were harvested at Stage II uncovering of the implants. The histologic and clinical results are reviewed.

Absorbable Implants↗
PubMed2002

Significance of biodegradable implants in case of midfacial fractures.

The purpose of this prospective clinical study was to evaluate new resorbable implants for bone fixation. The plates and screws are made of poly (D, L)lactide (PDLLA). Bioresorbable osteosynthesis and fixation (ResorbX) has been applied in 22 patients. Indications for operations were craniofacial trauma (malar, orbital-floor or frontal bone fractures) or orthognathic procedures (Le Fort-I-osteotomies) as well as the surgical correction in case of craniofacial syndromes. In the initial follow up, the first patients showed clinically and radiologically uneventful fixation and healing of the bone. There were no implant material related complications. Overall, the advantages of PDLLA-implants appear to be their ease of use, radiolucency and resorption, although further experience is needed to determine the longterm benefits of biodegradable implants.

Absorbable Implants↗
PubMed2003

Plates, screws, and children: their relationship in craniomaxillofacial trauma.

The ideal modality for fixation of pediatric craniomaxillofacial fractures remains elusive for a number of reasons. Surgeons who manage these injuries have replaced wiring techniques with the introduction of some form of reconstructive implant. The most commonly used implants are either resorbable or semi-rigid titanium. This presentation is a synopsis of the past 30 years of the English-speaking scientific literature including plastic and reconstructive surgery, otolaryngology, head and neck surgery, oral and maxillofacial surgery, pediatric, trauma, craniofacial, materials, and biomaterials publications. While no consensus on ideal management was observed, various implant treatment options are discussed, including their indications, contraindications, considerations, and consequences after implant placement.

Absorbable Implants↗