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PubMed2004

Rheological properties of PLGA film-based implants: correlation with polymer degradation and SPf66 antimalaric synthetic peptide release.

This paper reports on the rheological properties of poly(D,L-lactic-co-glycolic acid) polymers (PLGA) dispersions used to form films and of the implants prepared by compression of SPf66 antimalaric peptide between several films, before application and during drug release. 25% PLGA (M(w)=48,000Da) dispersions in dichloromethane showed viscous Newtonian behaviour, being easy flowing and adaptable to the moulds. Evolution of viscoelastic properties, polymer molecular weight, and SPf66 release pattern from the implants immersed in various media was evaluated. Oscillatory shear test showed that freshly prepared implants have an elastic modulus, G', greater than the viscous modulus, G", being both practically independent of angular frequency. After 6 weeks immersion in a pH 7.4 phosphate buffer, G' and G" increased in almost one order of magnitude, despite of a significant polymer degradation. Polymer molecular weight decreased slowly during the first 10 days of immersion (a similar pattern was obtained at pHs 2 and 7.4) and then the degradation process accelerated (degradation index on day 7 equals to 0.89, and on day 14 equals to 16.5). SPf66 release profile followed a pattern similar to that of the polymer degradation index. These observations are explained in terms of changes in polymer structure and conformation that happen in the implant.

Absorbable Implants↗
PubMed2003

The jumping distance revisited: An experimental study in the dog.

Following tooth extraction, a socket often presents dimensions that may be considerably greater that the diameter of a conventional implant. The present experiment was performed to study the healing that occurred adjacent to implants placed in recipient sites with a wide marginal defect. Four Labrador dogs were used. In the right side of the mandible, four experimental sites were prepared to receive titanium implants [sandblasted, large-grit, acid-etched (SLA) surface]. Traditional implant installation (control) was performed in one site. In the remaining three sites (test), a step drill was used to widen the marginal 5 mm of the canal. Following placement of an implant in a test site, a circumferential gap about 1-1.25 mm wide and 5 mm deep was present lateral to the implant. A resorbable barrier membrane was used to cover the implant and the bone tissue of two sites, while one site was left uncovered. Four months following implant installation, block biopsies of each implant site were obtained and prepared for ground sectioning. After 4 months of healing, the large marginal defect had been filled with newly formed bone. The degree of bone-to-implant contact between the newly formed tissue and the SLA surface was at all test sites high and similar to that obtained at control sites. The placement of a barrier membrane following implant installation did not improve the outcome of healing. We conclude that a marginal defect wider than 1 mm may heal with new bone and a high degree of osseointegration to an implant designed with a SLA surface.

Absorbable Implants↗
PubMed2001

Biomechanical investigations of different meniscal repair implants in comparison with horizontal sutures on human meniscus.

PURPOSE: The use of biodegradable implants for arthroscopic repair of meniscal lesions is becoming increasingly popular. The aim of this study was to test the biomechanical stability and the mode of failure of these implants. TYPE OF STUDY: Biomechanical testing study. METHODS: Biomechanical investigations were performed on human menisci using 6 commonly used biodegradable implants for meniscal repair to compare them with horizontal mattress suture using 2/0 Ethibond (Ethicon, Norderstedt, Germany). Included in this study were the Meniscus Arrow (Bionx, Tampere, Finland), Dart (Arthrex, Naples, FL), Stinger (Linvatec, Largo, FL), Meniscal Screw (Innovasive, Marlborough, MA), T-Fix (Acufex, Mansfield, MA), and the Fastener (Mitek, Westwood, MA). The tests were carried out using a material testing machine at a loading rate of 10 N/second. The ultimate tension load (UTL), elongation, and stiffness were evaluated for each implant technique. RESULTS: The highest UTL was shown by Ethibond (62 +/- 7.91 N) and the T-Fix (51.35 +/- 16.31 N), followed by the Fastener (32.67 +/- 2.97 N). All other implants had a significantly lower UTL (P =.001). Less elongation under a load of 5 N was noted for Ethibond (0.64 +/- 0.25 mm) and for T-Fix (0.43 +/- 0.32 mm) compared with the other implants. The greatest elongation was found for the Fastener (2.239 +/- 0.581 mm). The stiffness of the fixation was similar in all implants, except for the Dart and Fastener, which were significantly inferior (P <.05). CONCLUSIONS: All of the biodegradable implants had lower UTL than the suture techniques. Therefore, when using the implants, they should be inserted close together to provide sufficient stability. In cases of an extended lesion, there might even be an option to combine the implant and suturing techniques.

Absorbable Implants↗
PubMed2002

Orbital floor reconstruction with an alloplastic resorbable polydioxanone sheet.

The orbital floor is frequently reconstructed after blow-out fractures or midface fractures to avoid a relapse of the repositioned orbital tissue and to prevent enophthalmos. A total of 31 patients underwent reconstruction of internal orbital wall fractures with a resorbable 0.25 mm or 0.5 mm-thick polydioxanone implant (PDS). Skeletal and functional outcome was evaluated retrospectively with regard to fracture size. Fracture size was graded as small, moderate or large by CT scans and operating records. Two of the 25 patients with small or moderate defects showed an enophthalmos of 2-3 mm. Five of the six patients with large defects or two orbital wall fractures had enophthalmos. The scar that formed after implant resorption was to weak to provide adequate support of the globe or to compensate the enlarged orbital volume. Endoscopic follow-up examination of 12 patients showed yielding of the scar in the orbital floor already in moderate defects. Eight patients had diplopia in extreme gaze and two had significant diplopia. Blow-out and midfacial fractures with small to moderate defects in the orbital floor (up to a size of 2.5 cm2) can be reconstructed by polydioxanone sheet to avoid enophthalmos. Polydioxanone implants should only be used in cases without massive orbital fat herniation. The scar formed after implant resorption may influence functional outcome.

Absorbable Implants↗
PubMed2002

Investigation of a bioresorbable orbital implant.

PURPOSE: To analyze a new bioresorbable orbital implant (open-celled polylactic acid, also known as OPLA). METHODS: The implants were examined macroscopically, with chemical analysis (Fourier transform infrared spectroscopy), and microscopically with scanning electron microscopy. Animal implantation of OPLA implants was carried out in 9 adult male New Zealand albino rabbits. Implant vascularization was evaluated by histopathologic sectioning. RESULTS: The OPLA implant is porous and lightweight but fragile. Histopathologically it stimulated primarily a multinucleated giant cell granulomatous reaction with little fibrovascular ingrowth seen at 4 and 8 weeks. By 20 and 24 weeks, the implant was replaced predominantly by necrotic debris and peripheral giant cells. CONCLUSIONS: The OPLA implant is not an acceptable alternative to other currently available orbital implants.

Absorbable Implants↗
PubMed2001

Tetracycline modulates collagen membrane degradation in vitro.

BACKGROUND: Structural integrity of implanted bioabsorbable barrier membranes should be preserved for a sufficient time to ensure expected results. Collagen membranes are degraded by metalloproteinases (MMP). Their degradation rate can be altered either by enhancing structural integrity or by delaying the degradation process using MMP inhibitors. Tetracyclines (TTC) present inhibitory effects on matrix MMP. Immersing membranes in TTC solution before implantation can delay their degradation. The purpose of the present study was to evaluate the effect of collagen membranes immersed in varying TTC concentration solutions on the rate of their degradation in vitro. METHODS: Collagen bioabsorbable membranes were prepared as 5 mm diameter membrane discs. Membranes were then incubated at 4 degrees C for 24 hours, in either phosphate buffered saline (PBS, Ca2+ and Mg2+ free) or with TTC-HCl dissolved in PBS concentrations of 5 mg/ml, 50 mg/ml or 100 mg/ml. After rinsing, membranes were incubated with either bacterial collagenase or cultures of human bone lineage cells. Membrane degradation was studied on days 2, 4, 7, and 14. Two- and 3-way analysis of variance was used to analyze results. RESULTS: Samples supplemented with bacterial collagenase exhibited a statistically significant interaction between changes of free protein in the medium, antibiotic concentration used for the immersion, presence of collagenase in the medium, and incubation time (P<0.0001). Membranes incubated with bone cells exhibited similar degradation trends. CONCLUSIONS: Collagen membranes immersed in 50 mg/ml TTC solution exhibited the longest degradation time, both in the clostridial collagenase and the human bone cell lineage assays. Immersion in a 50 mg/ml TTC solution before implantation will delay their degradation.

Absorbable Implants↗
PubMed1999

Review of newer contraceptive agents.

Advances in contraceptive technology have made birth control more effective, convenient, and safe. We review the newer products and some under development, including the latest oral contraceptives, injectable progesterone, subdermal progestin implants, progesterone-releasing IUDs, emergency contraception, and male contraception.

Absorbable Implants↗
PubMedDate not supplied

Tomodensitometric and histologic evaluation of the combined use of a collagen membrane and a hydroxyapatite spacer for guided bone regeneration: a clinical report.

In this report, the problems of insufficient bone and soft tissue after extraction of maxillary incisors were addressed concurrently prior to endosseous implant placement, by combining the use of a diphenylphosphorylazide-cross-linked Type I collagen membrane and a resorbable space-making biomaterial composed of 200-micron porous hydroxyapatite granules blended in Type I collagen and chondroitin-4-sulfate. Upon flap reflection 8 months postsurgery, the horizontal deficiencies were almost completely resolved, membranes completely resorbed and the defects filled with hard, bonelike tissue, with a few superficial hydroxyapatite granules. Histologic evaluation of the bone biopsies obtained at the implantation sites revealed dense, well-reconstructed alveolar bone with a few traces of hydroxyapatite granules that had been completely resorbed. Tomodensitometric evaluation indicated that bone regeneration ranged from 14% to 58%, with an average bone gain of 29.77%. Four nonsubmerged ITI titanium implants placed in the augmented bone have been in function for more than 5 years, with no clinical or radiographic signs of hard or soft tissue breakdown. Bacterial sampling at dental sites with periodontitis 1 month prior to periodontal therapy and at implant sites for up to 30 months demonstrated rapid colonization of implant surfaces by periodontopathogens without causing any detrimental effect to implant integration.

Absorbable Implants↗
PubMed2002

Mechanical stretch regimen enhances the formation of bioengineered autologous cardiac muscle grafts.

BACKGROUND: Surgical repair of congenital and acquired cardiac defects may be enhanced by the use of autologous bioengineered muscle grafts. These tissue-engineered constructs are not optimal in their formation and function. We hypothesized that a mechanical stretch regimen applied to human heart cells that were seeded on a three-dimensional gelatin scaffold (Gelfoam) would improve tissue formation and enhance graft strength. METHODS AND RESULTS: Heart cells from children undergoing repair of Tetralogy of Fallot were isolated and cultured. Heart cells were seeded on gelatin-matrix scaffolds (Gelfoam) and subjected to cyclical mechanical stress (n=7) using the Bio-Stretch Apparatus (80 cycles/minute for 14 days). Control scaffolds (n=7) were maintained under identical conditions but without cyclical stretch. Cell counting, histology, and computerized image analysis determined cell proliferation and their spatial distribution within the tissue-engineered grafts. Collagen matrix formation and organization was determined with polarized light and laser confocal microscopy. Uniaxial tensile testing assessed tissue-engineered graft function. Human heart cells proliferated within the gelatin scaffold. Remarkably, grafts that were subjected to cyclical stretch demonstrated increased cell proliferation and a marked improvement of cell distribution. Collagen matrix formation and organization was enhanced by mechanical stretch. Both maximal tensile strength and resistance to stretch were improved by cyclical mechanical stretch. CONCLUSION: The cyclical mechanical stretch regimen enhanced the formation of a three-dimensional tissue-engineered cardiac graft by improving the proliferation and distribution of seeded human heart cells and by stimulating organized matrix formation resulting in an order of magnitude increase in the mechanical strength of the graft.

Absorbable Implants↗
PubMed2005

Pharmacokinetic behaviour of ACP gel, an autocrosslinked hyaluronan derivative, after intraperitoneal administration.

Autocrosslinked polysaccharide (ACP) gel is a fully biocompatible cross-linked derivative of hyaluronic acid, which has prolonged in vivo residence time and improved mechanical properties with respect to native hyaluronan for use in various surgical applications. The objective of this study was to assess the pharmacokinetic behaviour of ACP gel in dogs after intraperitoneal administration. Seven beagle dogs received intraperitoneal injections of tritium-labelled ACP gel. Blood samples were taken, and urine and faeces were collected until sacrifice, scheduled at various time points from 3 to 192 h after administration. Organs were removed from the animals at autopsy. Bodily fluid and organ samples were analysed for total and non-volatile radioactivity. Non-volatile radioactivity slowly appeared in plasma, with a median T(max) of 12 h, and then declined with a mean half-life of 69 h. Total radioactivity in plasma peaked later and declined more slowly, consistent with the formation of tritiated water. Little non-volatile radioactivity was found in any organs except the liver, where about 16% of the dose was present 72 h after administration, and the intestines, where the presence of radioactivity was probably due to a retention effect. A minor amount of non-volatile radioactivity was also found in the bone marrow. In summary, ACP gel administered into the peritoneal cavity is removed slowly by active initial catabolism at the injection site, and is then catabolised by well described physiological pathway of hyaluronan degradation with final release of simple molecules such as CO(2) and H(2)O. Given its in vivo residence time, ACP gel may be considered an ideal implantable surgical device.

Absorbable Implants↗
PubMed2005

Use of bio-resorbable implants for stabilisation of distal radius fractures: the United Kingdom patients' perspective.

Bio-resorbable implants have been, recently, introduced in the United Kingdom. To our knowledge there have been no randomised studies to assess perception of today's well-informed patients about this new method of fracture stabilisation. In order to assess the patients' perception a prospective study was performed on 100 consecutive adult patients with distal radius fractures. Following detailed verbal and written information about both resorbable and metal implants, the patients were asked to complete a specifically designed questionnaire. Ninety-five percent of the patients appreciated the 'resorbable' feature and responded that they would prefer to have their fracture stabilised with a resorbable implant. Conversely, 91% of the participants considered removal as the most negative aspect of the metal implant (p<0.0001). While 56% of the patients felt that it was relatively a new and evolving technology, 29% of them had apprehension about the relative strength of the resorbable implant. Eighty percent of the patients stated that they would be happy to participate in clinical trials to compare the use of bio-resorbable implants versus metal ones (p=0.0001). This study sets the foundation for the implementation of prospective randomised trials to assess the efficacy of the new generation of bio-resorbable implants.

Absorbable Implants↗
PubMed2006

Correction options for lipoatrophy in HIV-infected patients.

Lipoatrophy (LA) is a form of lipodystrophy, characterized by volume depletion caused by fat loss in the limbs, buttocks, and face. Facial volume loss is the most obvious outward sign of LA because it alters the facial contours in the cheeks, temples, and orbits. Lipodystrophy and LA are most commonly seen in patients with HIV on highly active antiretroviral therapy (HAART), which was introduced in the mid-1990s for the management of HIV, and is currently considered the mainstay therapy for HIV-infected patients. However, the etiology of LA is likely multifactorial as underlying patient conditions, including duration and severity of HIV and increasing age, have also been found to contribute to its occurrence. The volume loss of LA can be very dramatic with some patients exhibiting no signs of facial fat. As a result, many HIV-infected patients with associated LA suffer from psychological and lifestyle effects, which can lead to noncompliance with HAART. Thus, increases in facial volume and improvement in morphology is anticipated to reduce anxiety caused by LA in HIV-infected patients, and improve quality of life. This review discusses the benefits and limitations of several treatment options available to correct the volume depletion associated with LA, including antiretroviral switching, permanent surgical implants and injectables, poly-L-lactic acid, collagen, and hyaluronic acid derivatives.

Absorbable Implants↗
PubMed2000

Evaluation of guided bone regeneration in rabbit femur using collagen membranes.

The aim of the study was to evaluate the mechanical performance and the structure of neoformed bone around hydroxyapatite-coated titanium fixtures according to guided bone regeneration techniques. Ten hydroxyapatite-coated titanium fixtures were inserted in the femurs of five rabbits, in which a cortical defect was created and after the insertion of the fixture, covered with a resorbable membrane obtained from bovine Achilles tendon collagen Type I (A implant). In the same femur, a second fixture was inserted in similar cavities without application of the membrane (B implant). After 60 days, the animals were sacrificed, and block sections of the femoral bone containing the implants were embedded in polymethylmetacrylate and subjected to tensile shear-stress at break testing. After the detachment of the implants from the bone, their surfaces were examined with a scanning electron microscope. Tensile shear-stress values for A and B implant specimens were comparable to some extent, but the former had a lower performance. In this regard, scanning electron microscope observations showed that the neoformed cortical bone present cervically around implant A was much thicker than around implant B.

Absorbable Implants↗
PubMed2004

Bioabsorbable interbody cages in a sheep cervical spine fusion model.

STUDY DESIGN: An experimental study using a sheep cervical spine interbody fusion model. OBJECTIVES: To compare interbody fusion of an autologous tricortical iliac crest bone graft with two bioabsorbable cages and to determine whether there are differences between the three interbody fusion techniques in 1) the ability to preserve postoperative distraction, 2) the biomechanical stability, and 3) the histologic characteristics of intervertebral bone matrix formation. SUMMARY AND BACKGROUND DATA: Bioabsorbable cages would be beneficial compared with metallic cages; however, currently no suitable bioabsorbable interbody fusion cage is available. METHOD: Twenty-four sheep underwent C3/C4 discectomy and fusion. The following stabilization techniques were used: Group 1) autologous tricortical iliac crest bone graft (n = 8); Group 2) bioabsorbable cage made of 70/30 poly(l-lactide-co-d,l-lactide) (experimental) filled with autologous cancellous bone graft (n = 8); Group 3) bioabsorbable cage made of a polymer-calciumphosphate composite (Biomet Europe, Dordrecht, The Netherlands) filled with autologous cancellous bone graft (n = 8). Radiographic scans to determine disc space height were performed before and after surgery and after 1, 2, 4, 8, and 12 weeks, respectively. After 12 weeks, animals were killed, and fusion sites were evaluated using functional radiographic views in flexion and extension. Quantitative computed tomographic scans were used to assess bone mineral density, bone mineral content, and bony callus volume. Biomechanical testing was performed in flexion, extension, axial rotation, and lateral bending to determine stiffness, ROM, and neutral and elastic zone. Histomorphological and histomorphometrical analysis were performed to evaluate fusion and foreign body reactions associated with the bioabsorbable cages. RESULTS: Over a 12-week period, the polymer-calciumphosphate composite cage showed significantly higher values for disc space height compared with the bone graft and the poly(l-lactide-co-d,l-lactide) cage. Additionally, the polymer-calciumphosphate composite cage demonstrated a significantly higher stiffness and lower ROM, neutral zone, and elastic zone in axial rotation and lateral bending than any other group. However, quantitative computed tomographic scans demonstrated cracks in six of the eight polymer-calciumphosphate composite cages after 12 weeks. Histologically, the highest bone volume/total volume ratio and the highest fusion rate were found in the polymer-calciumphosphate composite cage group. Although the poly(l-lactide-co-d,l-lactide) cage showed grade I through III foreign body reactions in all fusion areas, only two animals developed grade I foreign body reactions with the polymer-calciumphosphate composite cage. CONCLUSION: After 12 weeks, there was no significant difference between the bioabsorbable poly(l-lactide-co-d,l-lactide) cage and the tricortical bone graft. In comparison to the tricortical bone graft, the bioabsorbable polymer-calciumphosphate composite cage showed significantly better distractive properties, a significantly higher biomechanical stiffness, and an advanced interbody fusion; however, six of eight polymer-calciumphosphate composite cages cracked. Although the fate of the foreign body reactions and the cracks is currently unclear for both bioabsorbable cages, the early appearance of large osteolysis associated with use of the poly(l-lactide-co-d,l-lactide) cage allows skepticism regarding the value of this bioabsorbable implant.

Absorbable Implants↗
PubMed2004

The use of bioabsorbable implants in spine surgery.

The use of bioabsorbable implants in spine surgery is expanding at a rapid pace. These implants are mimicking the roles of traditional metallic devices and are demonstrating similar efficacy in terms of maintaining stability and acting as carriers for grafting substances. Biomechanical studies have demonstrated their ability to stabilize effectively a degenerative cervical and lumbar motion segment. In numerous animal models, researchers have illustrated the ability of bioabsorbable implants to function satisfactorily as an interbody spacer and to achieve satisfactory bone fusion. Investigators have explored various opportunities for these implants to replace their metallic counterparts in clinical studies conducted in humans. The gradual resorption of these implants appears effectively to transfer gradual loads to the grafting substances promoting the biological mechanisms of fusion. Novel uses of bioabsorbable technology are constantly evolving. Their future as a carrier of biological agents such as bone morphogenetic proteins and bone graft extenders, their radiolucency, and their eventual resorption make them an ideal implant for use in spinal degenerative disease.

Absorbable Implants↗
PubMed1994

Treatment of radial head fractures with absorbable polyglycolide pins: a study on the security of the fixation in 38 cases.

Between 1986 and 1992, 43 patients with a displaced Mason type II or type III fracture of the radial head were treated by open reduction and internal fixation using absorbable polyglycolide pins. Five patients were lost to the follow-up. The clinical results were reviewed in 38 patients with an average follow-up time of 27 months. There were 19 type II and 19 type III fractures. The functional results were excellent or good in 36 patients (95%). A postoperative redisplacement was seen in one patient. Use of absorbable polyglycolide pins appear to be a feasible alternative method for the treatment of displaced radial head fractures. The results were at least equal to those obtained with metallic implants, but absorbable devices need not be removed. A complication unique to the absorbable devices is a transient local abacterial tissue reaction. The rate of tissue reaction has decreased lately, and in this study no adverse reactions from the implants occurred.

Adolescent↗
PubMed1999

[Fractures of the distal radius. Changing therapeutic strategies].

Fractures of the distal radius represent one of the most common fractures and do have high social-economic relevance. For treatment they need practicable classification and therapeutic standards. The demand for stable osteosynthesis of A3-, B2-B3 and C1-C2-fractures is connected to dorsal or volar internal fixation with plate and practical autogenous cancellous bone grafting, even for the elder patient. The isolated external fixation with K-wires represent special situation. Supply of implants and biodegradable materials will support this development.

Absorbable Implants↗