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PubMed2006

A biomechanical comparison of the FasT-Fix meniscal repair suture system and the RapidLoc device in cadaver meniscus.

PURPOSE: This biomechanical study compared the fixation characteristics of horizontally or vertically implanted FasT-Fix devices (Smith & Nephew, Endoscopy Division, Andover, MA) consisting of two 5-mm PLLA suture T-bar anchors with a pretied self-sliding knot (No. 0 nonabsorbable, USP, braided polyester suture material) and the RapidLoc device (Mitek Surgical Products, Westwood, MA) consisting of a PLLA T-bar anchor or "backstop," a connecting suture (No. 2 nonbiodegradable Ethibond; Ethicon, Somerville, NJ), and a PLLA grommet, for repairing posterior third lesions in human menisci. TYPE OF STUDY: Controlled laboratory biomechanical study. METHODS: After repair of a vertical longitudinal meniscus lesion with either vertically or horizontally implanted FasT-Fix devices or RapidLoc devices, 3 groups of 6 specimens underwent cyclic loading (5 mm/minute, cycling between 5 and 50 N at 1 Hz for 500 cycles) before load to failure testing on a servo hydraulic device. One-way analysis of variance and Tukey HSD post hoc tests were used to evaluate group differences (P < .05). RESULTS: The vertical FasT-Fix device group (3.2 +/- 0.49 mm) had less displacement after cyclic testing than either the horizontal FasT-Fix (4.4 +/- 0.73 mm, P = .003) or the RapidLoc (4.6 +/- 0.22 mm, P = .002) device groups. The vertical FasT-Fix device group had greater stiffness during cyclic testing (14.4 +/- 2.1 N/mm) than the horizontal FasT-Fix (10.4 +/- 1.6 N/mm, P = .0001) or the RapidLoc (9.7 +/- 0.44 N/mm, P = .0001) device groups. During load to failure testing, the vertical FasT-Fix group (125.3 +/- 39 N) had 28% greater strength than the horizontal FasT-Fix device group (89.7 +/- 14 N, P = .02) and 30% greater strength than the RapidLoc device group (87.1 +/- 13 N, P = .028), whereas displacement and stiffness did not show statistically significant group differences. CONCLUSIONS: The vertical FasT-Fix group had superior biomechanical characteristics for meniscal fixation during cyclic and load to failure testing compared with horizontal FasT-Fix or RapidLoc devices. CLINICAL RELEVANCE: Although the RapidLoc devices provided fixation characteristics comparable to horizontally implanted FasT-Fix devices, vertically implanted FasT-Fix devices may provide superior all-inside fixation.

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PubMed1999

Injection-molding versus extrusion as manufacturing technique for the preparation of biodegradable implants.

Polylactic acid (PLA) is a biocompatible and biodegradable material with wide utility for many applications, including the design of controlled-release systems for pharmaceutical agents. The factors determining the degradation kinetics of these systems include the composition and the molecular mass of the polymer, the morphology and the structure of the device, and the influence of thermal processes. The processing of the polymer determines the structure and design of the device, and influences to a high degree its morphology, namely its microporous structure, polymeric chain orientation and crystallinity.In this work, we aimed to compare the influence of two different implant manufacturing techniques, extrusion and injection-molding, on the in vitro degradation of the polymeric matrix. Both kinds of implants were loaded with a somatostatin analogue. Decrease in molecular weight, and polydispersity evolution during an accelerated in vitro degradation test were studied by size exclusion chromatography. Morphological changes in the polymeric matrix during degradation were followed after defined time intervals by means of scanning electron microscopy. Crystallinity studies were performed by differential scanning calorimetry and by X-ray analysis. Peptide stability in the polymeric matrix after both manufacturing methods was evaluated. Peptide release profiles, obtained in vitro during a week dissolution test, from both implant samples, were studied. It was shown that both molecular weight and polydispersity decreased after extrusion or injection-molding. This decrease was more pronounced with the latter technique. Crystallinity studies demonstrated that the crystalline network was not destroyed after both manufacturing methods. Peptide release profiles obtained in vitro were in good accordance with scanning electron microscopy. It was found that both manufacturing techniques had to be considered, although the extruded implants degraded more rapidly in vitro than the injection-molded ones.

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PubMed2002

Imaging of biodegradable osteosynthesis materials by ultrasound.

OBJECTIVE: Biodegradable osteosynthesis materials are not radio-opaque and therefore not visible on conventional X-rays. The aim of this study is to investigate the use of ultrasound for imaging biodegradable materials to detect and monitor the degradation process. METHODS: Forty-six patients had two different polylactide osteosynthesis fracture plate materials used for the fixation of midfacial fractures. A 7.5 MHz ultrasound transducer with a 4.2 x 0.9 cm footprint was used by two examiners at approximately 4-month intervals over 36 months to monitor changes of the latero-orbital and infra-orbital rims. RESULTS: Intrinsically amorphous 50 : 50 poly(D,L)lactide reached the maximum of thickness (about 300% of the initial thickness) between 14 and 18 months post-implantation and was totally resorbed in clinical and ultrasound examinations 30 months post-implantation. In 85 : 15 poly(L,D)lactide plates, the maximum of thickness (about 300% of the initial thickness) was reached between 22 and 26 months post-implantation and resorption was still in progress 36 months post-implantation. CONCLUSION: Ultrasound examinations are suitable for detecting and monitoring the degradation process of biodegradable osteosynthesis plates in the peri-orbital region.

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PubMed2005

Biodegradable X-ray markers of controlled radio-opacity. Temporary position measurements in bone.

In order to analyze X-ray markers for potential use in biodegradable implants or radiostereogrammatic analysis (RSA), we combined iopromide contrast fluid with biodegradable calcium phosphate cement. The radio-opacity of 10 x 10 mm markers containing different iodine concentrations (0, 120, 240, 360 and 720 mg per gram cement) was compared to an aluminium wedge of increasing (1-10 mm) thickness. The addition of iopromide increased the radio-opacity in a dose-dependent manner, which was comparable to 9-mm aluminium at concentrations of 240-720 mg/g. Radiographs of markers placed in explanted rabbit and in human femora were made to investigate the clinical accuracy for position determination. Markers of 1 x 1 mm (120 mg/g) were clearly discernable in all femora, and could be used to adequately measure distances of 5-45 mm (accuracy 0.10-2.19 mm). These markers might be embedded in biodegradable implants or used as temporary markers in the bone to analyze postoperative position on radiographs.

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PubMed2001

In vitro and in vivo evaluations of biodegradable implants for hormone replacement therapy: effect of system design and PK-PD relationship.

This investigation evaluated the feasibility of using subdermally implantable devices fabricated by nonconventional 3-dimensional printing technology for controlled delivery of ethinyl estradiol (EE2). In vitro release kinetics of EE2 and in vivo pharmacokinetics/pharmacodynamics in ovariectomized New Zealand White rabbits were carried out to study 3 implant prototypes: implant I (single-channel EE2 distribution in polycaprolactone polymer core), implant II (homogeneous EE2 distribution in polycaprolactone polymer matrix), and implant III (concentration-gradient EE2 distribution in polycaprolactone and poly(dl-lactide-co-glycolide) (50:50 matrix). EE2 was found to be released from all the implants in a nonlinear pattern with an order of implant III > implant II > implant I. The noncompartmental pharmacokinetic analysis of plasma EE2 profiles in rabbits indicated a significant difference (p < .05) in Cmax, tmax, and mean residence time between implant I and implants II and III, but no difference in the area under the plasma concentration time curves calculated by trapezoidal rule (AUC) among the implants. For pharmacodynamic studies, endogenous follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels were observed to be suppressed following implantation of all implants, which demonstrated that a therapeutically effective dose of EE2 had been delivered. Furthermore, the noncompartmental analysis of plasma FSH and LH profiles in rabbits showed a significant difference (p < .05) in AUC and the mean residence time between implant III and implants I and II. A good in vivo/in vitro relationship was observed between daily amounts of EE2 released and plasma profiles of EE2 for all implants. This relationship suggests that plasma profiles of EE2 could be predicted from in vitro measurement of daily amount of EE2 released. Therefore, performing in vitro drug release studies may aid in the development of an EE2 implant with the desired in vivo release rate.

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PubMed2006

[First results of the investigation of the stability and tissue integration of a degradable, elastomeric copolymer in an animal model].

The stability and tight integration into adjacent tissue of a novel, degradable, elastic copolymer were examined in an animal model. The biomaterial was used for the reconstruction of a gastric wall defect in Sprague-Dawley rats (n=42) to test the polymeric material under the extreme chemical, enzymatical and mechanical conditions of the stomach. In the control group (n=21) the same defect of the gastric wall was primarily closed without biomaterial implantation. In the baseline group (n=21) the animals were kept under standard conditions without any surgical procedure. The implantation periods were 1 week, 4 weeks and 6 months. The animals' weight was determined preoperatively and before explantation. After explantation, air was pumped into the stomach and the pressure was measured by using a pressure-gauge in order to test whether the surgically produced union of the stomach wall and the polymer patch was gas-tight. After 1 week of implantation time a statistically significant increase of the body weight of the animals was found only in the baseline group. Four weeks and 6 months after the abdominal surgical procedure, a statistically significant increase of the animals' weight was found in the implantation group, the control and the baseline group. Gastrointestinal complications like fistula, perforation or peritonitis did not occur in any of the animals. The measurement of the stomach pressure after maximal gas insufflation did not show significant differences between the implantation group, the control and the baseline group in any of the time periods investigated. Despite very high strains of the gastric wall, no gas leakage was detected. There was a tight connection between the polymer and the adjacent stomach wall in all animals investigated. An adequate mechanical stability of the biomaterial was detectable under the extreme pathophysiological conditions of the stomach milieu. A fast and unfavourable degradation of the degradable polymer was not found in any of the animals. Further investigations are needed to analyse the mechanisms of the tissue integration of the biomaterial as well as the degradation kinetic of the polymer and the process of the tissue remodeling. The knowledge of these processes is necessary to adapt the novel biomaterial and thus prepare it for the use and implantation in different body locations and to develop novel therapeutical options in medicine.

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PubMed2003

Periodontal repair in dogs: a bioabsorbable calcium carbonate coral implant enhances space provision for alveolar bone regeneration in conjunction with guided tissue regeneration.

BACKGROUND: Collapse or compression of a barrier device into a periodontal defect or onto the root surface compromises outcomes following guided tissue regeneration (GTR). Bone biomaterials have been suggested to support regeneration of alveolar bone and to improve space provision with GTR devices. The objective of this study was to evaluate space provision, alveolar bone, and cementum regeneration following use of a bioabsorbable, calcium carbonate biomaterial in conjunction with GTR. METHODS: Routine, critical size, 5 to 6 mm, supraalveolar, periodontal defects were created in 5 young adult beagle dogs. Alternate jaw quadrants in consecutive animals received GTR and the coral biomaterial (cGTR) or GTR alone. The animals were euthanized 4 weeks postsurgery and tissue blocks processed for histometric analysis. RESULTS: The coral implant particles were surrounded by newly-formed bone or immersed in connective tissue and appeared to resorb and be replaced by bone. There was limited, if any, appreciable cementum regeneration. Space provision was enhanced in cGTR compared to GTR sites (6.1 +/- 1.6 versus 2.4 +/- 0.8 mm2; P<0.05). Bone regeneration (height) was significantly increased in cGTR compared to GTR sites averaging 1.9 +/- 0.6 and 1.2 +/- 0.6 mm, respectively (P<0.05). Bone regeneration (area) was 2-fold greater in cGTR sites compared to the GTR control (3.3 +/- 1.8 versus 1.4 +/- 0.5 mm2), however the difference was not statistically significant (P>0.05). CONCLUSIONS: The coral implant significantly enhanced space provision for GTR while alveolar bone formation appeared to be enhanced by its use. Increased healing intervals are needed to fully understand the biologic value of the coral implant as an adjunct to GTR.

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PubMed2002

Applications of a resorbable interbody spacer via a posterior lumbar interbody fusion technique.

Polyhydroxyacids are a promising class of bioresorbable materials withpotential applications in spinal surgery. One such polymer, MacroPore (MacroPore Biosurgery Inc, San Diego, Calif), offers a balance of strength, predictable degradation, lack of stimulus of foreign body reaction, and biocompatibility with neural tissue. MacroPore can be formed into an array of shapes and can be manufactured, sterilized, and stored with conventional techniques. Limited clinical experience has been gained with bioresorbable implants that are used as load-sharing devices in a posterior lumbar interbody fusion construct.

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PubMed2005

The use of bioabsorbable implants as orthodontic anchorage in dogs.

The purpose of this study was to investigate the possibility of using a bioabsorbable implant as orthodontic anchorage. The implant under investigation in this study was a miniscrew, 2.0 mm x 8.0 mm, made from poly-L-lactic acid (PLLA; molecular weight: 200,000), a bioabsorbable bone-bonding material. The implants were placed in the mandibles of eight male beagle dogs. After implantation, traction was immediately applied to the third premolar (P3) using the implant as anchorage. After the completion of each study period (three and six months) following installation, tensile test, histological examination, and molecular weight measurement were performed. The results suggested that the bioabsorbable implant evaluated had favorable biocompatibility and strength, and that it showed promising potential for use in orthodontic treatment.

Absorbable Implants↗

PubMed1999

Bioabsorbable fixation in the treatment of proximal tibial osteotomies and fractures. A clinical study.

BACKGROUND AND AIMS: The purpose of this study was to evaluate the use of bioabsorbable implants in proximal tibia cancellous bone fixations in 28 patients. PATIENTS AND METHODS: The implants used were self-reinforced polyglycolide (SR-PGA) or self-reinforced polylactide (SR-PLLA) screws or rods. In six patients a high tibial osteotomy and in 16 patients a proximal tibial plateau fracture were secured with these implants (cancellous bone fixations). In addition, four anterior tibial eminence avulsion fractures and two tibial tuberosity avulsions were fixed (avulsion fractures). The average follow-up time was 3.6 years. RESULT AND CONCLUSIONS: In the cancellous bone fixations (15 patients at the follow-up) there were three excellent clinical results, five good, five moderate and two poor results; radiologically there were one excellent result, eight good, five moderate, and one poor result. In the avulsion fracture patients (four patients at the follow-up) there were two excellent and two good clinical results; radiologically all results were excellent. In four cancellous bone fixations redisplacement was noted. In all patients the functional score was 25.6/30 (Rasmussen 1973). The bioabsorbable implants can be used for fixation of proximal tibial cancellous bone osteotomies and fractures and avulsion fractures with good or moderate results.

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PubMed2004

Early findings in a pilot study of anterior cervical interbody fusion in which recombinant human bone morphogenetic protein-2 was used with poly(L-lactide-co-D,L-lactide) bioabsorbable implants.

OBJECT: The goal of this study was to assess the efficacy of bioabsorbable interbody spacers in cervical spine fusion. METHODS: The authors report on a prospective examination of 20 patients with degenerative cervical disc disease who underwent anterior cervical fusion at 28 total levels. The authors used Infuse bone graft (that is, recombinant human bone morphogenetic protein-2 applied to an absorbable collagen sponge and contained within a Cornerstone-HSR bioabsorbable spacer. Multiple-level fusions were performed in 30% of these patients. At 3 months postfusion, radiographs and computerized tomography scans demonstrated bridging bone in 100% of the patients. Improvement from baseline scores in physical functioning, mental health, and bodily pain was demonstrated at 3 months postoperatively according to results of the Short Form-36 Version 2 health survey. There were no device-related complications. CONCLUSIONS: The results in this series indicate that the use of Cornerstone-HSR as a bioabsorbable interbody spacer in combination with Infuse bone graft may be an alternative treatment for cervical spine fusion.

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PubMed2006

Intraarticular migration of a broken biodegradable interference screw after anterior cruciate ligament reconstruction.

Poly-L: -lactic acid biodegradable screws have been used effectively for graft fixation in anterior cruciate ligament (ACL) reconstruction. The overall complication rate associated with the use of this implant is low, although some authors reported complications, such as osteolysis and aseptic effusion of the knee joint. We report a case of a 29-year-old female patient with a failure of a biodegradable interference screw at 22 months after ACL reconstruction using bone-patellar tendon-bone graft. In this illustrated case, the screw broke and migrated into the knee joint. In addition, we performed a detailed review of the medical literature from 1990-2005 to identify possible causes of biodegradable screw failures. We identified six published cases of bioabsorbable interference screw failure with migration into the knee joint. Several authors have reported small diameter of the screw, poor bone quality, bone resorption, and screw divergence as potential causes for intraarticular migration of metallic interference screws. With regard to bioscrews, no specific risk factors for screw breakage and intraarticular migration have been reported. ACL reconstruction with the use of bioabsorbable interference screws for fixation is considered to be reliable. However, we need to be aware of potential problems associated with the use of this implant. Early recognition of bioscrew failure may prevent associated morbidities, such as subsequent cartilage damage.

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PubMed2004

Tissue engineering of biphasic cartilage constructs using various biodegradable scaffolds: an in vitro study.

Biological restoration of osteochondral defects requires suitable subchondral support material that also allows the induction of hyaline cartilage tissue. Biphasic implants consisting of pre-fabricated neocartilage and an underlying biodegradable osteoconductive base may meet these requirements. Here we explore various candidate biodegradable support materials onto which neo-cartilage was produced in vitro. Porcine chondrocytes were seeded in a closed and static bioreactor with a base of biomaterial consisting of either poly-L-lactide [P(L)LA], poly-d,l-lactide [P(D,L)LA] or Collagen-hydroxyapatite [Col-HA] and were cultured for 15 weeks. Viable neo-cartilage was produced on each biomaterial with differing amounts of cellular colonisation. P(D,L)LA breakdown was more rapid and uneven among the three biomaterials, leading to constructs of irregular shape. Little or no breakdown or chondrocyte colonisation was evident in P(L)LA. Col-HA constructs were superior in terms of viability, implant morphology and integration between neo-cartilage and biomaterial. These results indicate that our reported system has potential for producing biphasic implants that may be adequate for the repair of osteochondral defects.

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PubMed2006

A biodegradable levonorgestrel-releasing implant made of PCL/F68 compound as tested in rats and dogs.

PURPOSE: Our objective was to report preclinical studies on a biodegradable long-acting contraceptive implant. METHODS: A poly (epsilon-caprolactone) (PCL)/pluronic F68 (F68) compound was used to construct an implant, which was filled with dry levonorgestrel (LNG) powder (PCL/F68/LNG). LNG release rate, contraceptive efficacy and polymer degradation were evaluated in rats and followed for 2 years. A 2-year toxicity study was conducted in dogs. RESULTS: The in vitro and in vivo release of LNG from the implant followed zero-order release kinetics. Serum LNG level in rats was very stable during the 2-year period. Studies on polymer degradation indicated that the molecular weight of PCL dropped from 66,000 to 15,000 Da, but the implant was still in good shape by the end of 2 years. CONCLUSION: Toxicological study demonstrated that the PCL/F68 polymer had no adverse effect in all aspects. The contraceptive efficacy in rats showed dose response. The implant was physically and chemically stable for up to 3 years in airproof aluminum foil packing at room temperature.

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PubMed2003

Fabrication of poly(propylene fumarate)-based orthopaedic implants by photo-crosslinking through transparent silicone molds.

This work presents a new molding process for photo-crosslinked, degradable polymeric networks of poly(propylene fumarate) (PPF) and the crosslinking agent poly(propylene fumarate)-diacrylate (PPF-DA). Transparent room temperature vulcanizing silicone molds were fabricated for parts ranging from simple test coupons to orthopaedic implants. The PPF/PPF-DA resin blend was injected into the cavity and photo-crosslinked as light was transmitted through the mold wall. The volumetric shrinkage, mechanical properties, and the effects of gamma sterilization were reported for molded PPF/PPF-DA networks prepared with varying compositions of the two polymer components. The shrinkage decreased while the mechanical properties displayed a general increasing trend when more of the crosslinking agent was incorporated into the network. Gamma irradiation resulted in an improvement of the mechanical properties. In addition, PPF/PPF-DA replicates of a 70:30 poly(L/DL-lactide) biodegradable fixation plate and a bone allograft interbody fusion spacer were produced to evaluate the performance of PPF/PPF-DA as an orthopaedic implant and allow for a comparison to be made with materials that have been established for clinical use.

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PubMed1999

Biomaterials in the face: benefits and risks.

An extensive review of biomaterials in the face was conducted in an American Society of Maxillo-facial Surgeons-sponsored biomaterials symposium. The symposium was held in Boston, MA, immediately preceding the 1998 annual meeting of the ASPRS/PSEF. The scope of the symposium extended from current reconstructive techniques for the facial skeleton, including autogenous bone and biomaterials, to potential application of new techniques in molecular biology that may enable the body's own tissues to be engineered to provide bone and cartilage to reconstruct the facial skeleton. The authors review the presentations and relevant literature on biomaterials in the face. The following topics are reviewed: current reconstructive techniques using autogenous bone grafts, methyl methacrylate cranioplasty, demineralized bone, and hydroxyapatite; biomaterials used for rigid fixation, including metallic and bioabsorbable implants; biomaterials used for facial augmentation, including porous polyethylene, hard-tissue replacement, and ceramic biomaterials; biofilm, or a layered polysaccharide matrix secreted by bacteria on the surface of implants; and potential means of inducing bone formation by directing the body's own tissues through cytokine interaction, gene transfer, and tissue engineering.

Absorbable Implants↗

PubMed2006

Prevention of experimental proliferative vitreoretinopathy with a biodegradable intravitreal drug delivery system of all-trans retinoic acid.

PURPOSE: To evaluate the antiproliferative effect of an all-trans retinoic acid (at-RA) drug delivery system (DDS) on experimental proliferative vitreoretinopathy (PVR). METHODS: PVR was induced in rabbits with core vitrectomy and fibroblast injection. The DDS containing 420 microg, 650 microg, and 1,070 microg of at-RA was implanted into the vitreous of treated groups B, C, and D, respectively. Group A with no DDS and group E with nonmedicated DDS served as controls. The intravitreal at-RA concentration was measured with high-pressure liquid chromatography. The drug toxicity was evaluated histologically. RESULTS: The severity of PVR was significantly reduced in groups C and D but not in groups A, B, and E. The drug release peaked at 6 weeks to 7 weeks. No signs of retinal toxicity were found in the DDS groups. CONCLUSION: Intravitreal implantation of at-RA DDS appears effective in inhibiting the development of PVR and is well tolerated in rabbit eyes.

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PubMed2003

Biodegradable intrascleral implant for sustained intraocular delivery of betamethasone phosphate.

PURPOSE: To evaluate the feasibility of using a biodegradable intrascleral implant for intraocular sustained delivery of betamethasone phosphate (BP). METHODS: The intrascleral implant (0.5 mm thick and 4 mm in diameter) was made of poly(DL-lactide) containing 25% betamethasone phosphate. The in vitro release of BP from the implant was evaluated by high-performance liquid chromatography (HPLC). The implants were placed into a scleral pocket in the rabbit's eye. The concentrations of BP in the aqueous humor, vitreous, and retina-choroid were measured by HPLC. The toxicity and biocompatibility of the implant were evaluated by slit lamp examination, electroretinography, and light microscopy. RESULTS: In vitro studies demonstrated that the implants released BP in a biphasic pattern for at least 8 weeks. The BP concentrations in the vitreous and the retina-choroid remained within the concentration range capable of suppressing inflammatory responses for more than 8 weeks. The BP concentration was greater in the retina-choroid than in the vitreous. In the aqueous humor, BP was below the detection limit during the observation period. No significant toxicity to the retina was observed. Also, the implant showed good biocompatibility in the eye. CONCLUSIONS: These results suggest that the intrascleral implant would be a promising system for delivery of steroid to the posterior segment of the eye.

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