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Large animal models are highly recommended for meaningful preclinical studies, including the optimization of cement augmentation for vertebral body defects by vertebroplasty/kyphoplasty.
The aim of this study was to perform a systematic characterization of a strictly minimally invasive in vivo large animal model for lumbar ventrolateral vertebroplasty.
This is a prospective experimental animal study.
Lumbar defects (diameter 5 mm; depth approximately 14 mm) were created by a ventrolateral percutaneous approach in aged, osteopenic, female sheep (40 Merino sheep; 6–9 years; 68–110 kg). L1 remained untouched, L2 was left with an empty defect, and L3 carried a defect injected with a brushite-forming calcium phosphate cement (CPC). Trauma/functional impairment, surgical techniques (including drill sleeve and working canula with stop), reproducibility, bone defects, cement filling, and functional cement augmentation were documented by intraoperative incision-to-suture time and X-ray, postoperative trauma/impairment scores, and ex vivo osteodensitometry, microcomputed tomography (CT), histology, static/fluorescence histomorphometry, and biomechanical testing.
Minimally invasive vertebroplasty resulted in short operation times (28±2 minutes; mean±standard error of the mean) and X-ray exposure (1.59±0.12 minutes), very limited local trauma (score 0.00±0.00 at 24 hours), short postoperative recovery (2.95±0.29 hours), and rapid decrease of the postoperative impairment score to 0 (3.28±0.36 hours). Reproducible defect creation and cement filling were documented by intraoperative X-ray and ex vivo conventional/micro-CT. Vertebral cement augmentation and osteoconductivity of the CPC was verified by osteodensitometry (CPC>control), micro-CT (CPC>control and empty defect), histology/static histomorphometry (CPC>control and empty defect), fluorescence histomorphometry (CPC>control; all p<.05 for 3 and 9 months), and compressive strength measurements (CPC numerically higher than control; 102% for 3 months and 110% for 9 months).
This first-time systematic clinical assessment of a minimally invasive, ventrolateral, lumbar vertebroplasty model in aged, osteopenic sheep resulted in short operation times, rapid postoperative recovery, and high experimental reproducibility. This model represents an optimal basis for standardized evaluation of future studies on vertebral augmentation with resorbable and osteoconductive CPC.
BACKGROUND CONTEXT: Targeted delivery of osteoinductive bone morphogenetic Proteins (eg, GDF5) in bioresorbable calcium phosphate cement (CPC), potentially suitable for vertebroplasty and kyphoplasty of osteoporotic vertebral fractures, may be required to counteract augmented local bone catabolism and to support complete bone regeneration. The biologically optimized GDF5 Mutant BB-1 may represent an attractive drug candidate for this purpose.
PURPOSE: The aim of the current study was to test an injectable, poly (l-lactide-co-glycolide) acid (PLGA) fiber-reinforced, brushite-forming CPC containing low-dose BB-1 in a sheep lumbar osteopenia model.
STUDY DESIGN/ SETTING: This is a prospective experimental animal study.
METHODS: Bone defects (diameter 5 mm) were generated in aged, osteopenic female sheep and were filled with fiber-reinforced CPC alone (L4; CPC+fibers) or with CPC containing different dosages.
BACKGROUND CONTEXT:
Bioresorbable calcium phosphate cement (CPC) may be suitable for vertebroplasty/kyphoplasty of osteoporotic vertebral fractures. However, additional targeted de-
livery of osteoinductive bone morphogenetic Proteins (BMPs) in the CPC may be required to counteract the augmented local bone catabolism and support complete bone regeneration.
PURPOSE:
This study aimed at testing an injectable, poly (l-lactide-co-glycolide) acid (PLGA) fiber-reinforced, brushite-forming cement (CPC) containing low-dose bone morphogenetic Protein BMP-2 in a sheep lumbar osteopenia model.
STUDY DESIGN/ SETTING:
This is a prospective experimental animal study.
METHODS:
Bone defects (diameter 5 mm) were generated in aged, osteopenic female sheep and filled with fiber-reinforced CPC alone (L4; CPC+ fibers) or with CPC containing different dosages of BMP-2 (L5; CPC+ fibers + BMP-2; 1, 5, 100, and 500g BMP-2; n=5 or 6 each). The results were
compared with those of untouched controls (L1). Three and 9 months after the operation, structural and functional effects of the CPC (±BMP-2) were analyzed ex vivo by measuring
(1) bone Mineral density (BMD);
(2) bone structure, that is, bone volume/total volume (assessed by micro-computed tomography [micro-CT] and histomorphometry), trabecular thickness, and trabecular number;
(3) bone formation, that is, osteoid volume/bone volume, osteoid surface/bone surface, osteoid thickness, mineralizing surface/bone surface, mineral Apposition rate, and bone formation rate/bone surface;
(4) bone resorption, that is, eroded surface/bone surface; and
(5) compressive strength.
RESULTS:
Compared with untouched controls (L1), CPC+ fibers (L4) and/or CPC+ fibers + BMP-2(L5) significantly improved all parameters of bone formation, bone resorption, and bone structure.
These effects were observed at 3 and 9 months, but were less pronounced for some parameters at 9 months. Compared with CPC without BMP-2, additional significant effects of BMP-2 were demonstrated for bone structure (bone volume/total volume, trabecular thickness, trabecular number) and formation (osteoid surface/bone surface and mineralizing surface/bone surface), as well as for the compressive strength. The BMP-2 effects on bone Formation at 3 and 9 months were dose-dependent, with 5–100g as the optimal dosage.
CONCLUSIONS:
BMP-2 significantly enhanced the bone formation induced by a PLGA fiber-reinforced CPC in sheep lumbar osteopenia. A single local dose as low as ≤100g BMP-2 was sufficient
to augment middle to long-term bone formation. The novel CPC+ BMP-2 may thus represent an alternative to the bioinert, supraphysiologically stiff polymethylmethacrylate cement presently used to treat osteoporotic vertebral fractures by vertebroplasty/kyphoplasty.
BACKGROUND CONTEXT:
Biodegradable calcium phosphate cement (CPC) represents a promising option for the surgical treatment of osteoporotic vertebral fractures. Because of augmented local bone catabolism, however, additional targeted delivery of bone morphogenetic proteins with the CPC may be needed to promote rapid and complete bone regeneration.
PURPOSE:
In the present study, an injectable, poly(l-lactide-co-glycolide) acid (PLGA) fiber-reinforced, brushite-forming cement (CPC) containing the bone morphogenetic Protein GDF5 was tested in a sheep lumbar osteopenia model.
STUDY DESIGN/SETTING:
This is a prospective experimental animal study
METHODS:
Defined bone defects (diameter 5 mm) were placed in aged, osteopenic female sheep.
Defects were treated with fiber-reinforced CPC alone (L4; CPC+ fibers) or with CPC containing different dosages of GDF5 (L5; CPC+ fibers + GDF5; 1, 5, 100, and 500g GDF5; n =
5 or 6 each).
The results were compared with those of untouched controls (L1). Three and 9 months postoperation, structural and functional effects of the CPC (±GDF5) were assessed ex vivo by measuring
(1) bone mineral density (BMD);
(2) bone structure, that is, bone volume/total volume (assessed by micro-computed tomography and histomorphometry), trabecular thickness, and trabecular number;
(3) bone formation, that is, osteoid volume/bone volume, osteoid surface/bone surface, osteoid thickness, mineralized surface/bone surface, mineral apposition rate, and bone formation rate/bone surface;
(4) bone resorption, that is, eroded surface/bone surface; and
(5) compressive strength.
RESULTS:
Compared with untouched controls (L1), both CPC+ fibers (L4) and CPC+ fibers + GDF5 (L5) numerically or significantly improved all parameters of bone formation, bone resorption, and bone structure. These significant effects were observed both at 3 and 9 months, but for some parameters they were less pronounced at 9 months. Compared with CPC without GDF5, additional significant effects of CPC with GDF5 were demonstrated for BMD and parameters of bone formation and structure (bone volume/total volume, trabecular thickness, and trabecular number, as well as mineralized surface/bone surface). The GDF5 effects were dose-dependent (predominantly in the 5–100g range) at 3 and 9 months.
CONCLUSIONS:
GDF5 significantly enhanced the bone formation induced by a PLGA fiber-reinforced CPC in sheep lumbar osteopenia. The results indicated that a local dose as low as ≤100g
GDF5 may be sufficient to augment middle to long-term bone formation. The novel CPC+ GDF5 combination may thus qualify as an alternative to the bioinert, supraphysiologically stiff poly-(methyl methacrylate) cement currently applied for vertebroplasty/kyphoplasty of osteoporotic vertebral fractures.
Novel DOPO-based flame retardants in high-performance carbon fibre epoxy composites for aviation
(2011)
Two novel, halogen-free, phosphorus-based oligomeric flame retardants are investigated in the commercial epoxy resin RTM6 and ~70 wt.% carbon fibre RTM6 composites (RTM6-CF) with respect to pyrolysis and fire behaviour. The flame retardants are based on 9,10-dihydro-9-oxy-10-phosphaphenanthrene-10-oxide (DOPO) units linked to the star-shaped aliphatic ground body tetra-[(acryloyloxy)ethyl] pentarythrit (DOPP), or heterocyclic tris-[(acryloyloxy)ethyl] isocyanurate (DOPI), respectively. The glass transition temperature is reduced by adding DOPP and DOPI, but the mechanical properties of the composites (e.g. interlaminar shear strength (ILSS) and Gc in mode I and II) remain unchanged. Decomposition models are proposed based on mass loss, evolved gas analysis (TGFTIR) and condensed product analysis (hot stage cell within FTIR). The fire behaviour is investigated comprehensively (UL 94, limiting oxygen index (LOI) and cone calorimeter). Both flame retardants act in the gas phase through flame inhibition and in the condensed phase through charring. The UL 94 of RTM6 is improved from HB to V-1 and V-0; the LOI from 25% to 3438%. Peak heat release rate (PHRR) and total heat evolved (THE) are lowered by 31-49% and 4044%, respectively. Adding CF increases the residue, reduces the THE, but suppresses the charring due to RTM6 and flame retardants. Thus the THE of RTM6-CF is reduced by about 25% when DOPI and DOPP are added. However, UL 94: V-0 and LOI of 45% and 48% are achieved with ~0.6 wt.% phosphorus.
The pyrolysis and fire behavior of halogen-free flame-retarded DGEBA/DMC, RTM6 and their corresponding 60 vol.-% carbon fibers (CF) composites were investigated. A novel phosphorous compound (DOPI) was used. Its action is dependent on the epoxy matrix. DGEBA/DMC and DOPI decompose independently of each other. Only flame inhibition occurs in the gas phase. RTM6 shows flame inhibition and a condensed phase interaction increasing charring. Both mechanisms decrease with increasing irradiance, whereas in RTM6-CF charring is suppressed at low ones. RTM6+DOPI shows a higher LOI (34.2%) than DGEBA/DMC+DOPI and a V-0 classification in UL 94. Adding CF only enhances the LOI, DOPI+CF leads to a superposition in LOI for DGEBA/DMC-CF+DOPI (31.8%, V-0) and a synergism for RTM6-CF+DOPI (47.7%, V-0).
Vertebroplasty or kyphoplasty of osteoporotic vertebral fractures bears the risk of pulmonary cement embolism (3.5%–23%) caused by leakage of commonly applied acrylic polymethylmethacrylate (PMMA) cement to spongious bone marrow or outside of the vertebrae. Ultraviscous cement and specific augmentation systems have been developed to reduce such adverse effects. Rapidly setting, resorbable, physiological calcium phosphate cement (CPC) may also represent a suitable alternative.
PURPOSE: This study aimed to compare the intravertebral extrusion of CPC and PMMA cement in an ex vivo and in vivo study in sheep.
STUDY DESIGN/SETTING: A prospective experimental animal study was carried out. METHODS: Defects (diameter 5 mm; 15 mm depth) were created by a ventrolateral percutane-ous approach in lumbar vertebrae of female Merino sheep (2–4 years) either ex vivo (n = 17) or in vivo (n = 6), and injected with: (1) CPC (L3); (2) CPC reinforced with 10% poly(l-lactide-co-glycolide) (PLGA) fibers (L4); or (3) PMMA cement (L5; Kyphon HV-R). Controls were untouched (L1) or empty defects (L2). The effects of the cement injections were assessed in vivo by blood gas analysis and ex vivo by computed tomography (CT), micro-CT (voxel size: 67 µm), histology, and biomechanical testing.
In diesem Beitrag soll das Validierungskonzept der IBESS-Prozedur, sowie erste Ergebnisse und Erkenntnisse der noch gegenwärtig laufenden Validierung vorgestellt werden. Die Vorstellung erfolgt dabei am Beispiel der im Projekt eingesetzten geschweißten Stumpfstoß- sowie Kreuzstoßverbindung. Neben der Validierung des analytischen bruchmechanischen Modells zur Ermittlung der Schwingfestigkeit, steht auch die Validierung von Kriterien zur Interaktion und Koaleszenz von kurzen Mehrfachrissen im Fokus.
Bruchmechanischen Bewertungsmethoden liegt stets eine tatsachlich vorhandene oder fiktive Anfangsrisslange zu Grunde. Schweißverbindungen sind mit strukturellen Imperfektionen wie beispielsweise lnhomogenitaten in der Mikrostruktur und den Werkstoffeigenschaften behaftet, welche auf der Werkstoffseite berücksichtigt werden können. Imperfektionen wie der Kantenversatz und der Nahtübergangsradius, die als außere geometrische Imperfektionen aufgefasst werden können, haben vor allem Auswirkungen auf den Spannungszustand und werden daher auf der Lastseite erfasst. Innere geometrische Imperfektionen wie Einschlüsse oder Poren, von welchen Risse initiieren und sich ausbreiten, können als Ausgangsrissgröße aufgefasst werden. Im Teilprojekt A1 des Forschungsclusters IBESS wurden außere geometrische Imperfektionen an Schweißverbindungen ermittelt und statistisch ausgewertet. Des Weiteren wurden Schweißverbindungen fraktografisch im Rasterelektronenmikroskop (REM) bezüglich innerer geometrischer Imperfektionen untersucht, jedoch konnten aufgrund der hohen Schweißgütekeine schadigungsrelevanten inneren Imperfektionen (Ausgangsdefekte) detektiert werden.
Um dennoch eine Ausgangsrisskonfiguration zu bestimmen, wurden "Heat-Tinting" Versuche eingesetzt, mit denen auf der Bruchflache verschiedene Anrissstadien markiert werden können. Mit dem .Heat-Tinting" Verfahren können sehr kleine Anrisse detektiert und in Abhangigkeit von der Beanspruchung frühe Anrisskonfigurationen ermittelt werden.
Des Weiteren haben Zerbst und Madia im Teilprojekt A3 ein Modell entwickelt, mit dem für den Grundwerkstoff mittels zyklischer R-Kurven eine Ausgangsrissgröße rechnerisch ermittelt werden kann. Unter Verwendung der Ergebnisse aus den Versuchen zur Ermittlung der Anrissstadien soll dieses Modell validiert werden, um auch für Schweißverbindungen Anwendung zu finden.
To assess the clinical course of a sheep stifle joint model for osteochondral (OC) defects, medial femoral condyles (MFC) were exposed without patella luxation using medial parapatellar skin (3–4 cm) and deep incisions (2–3 cm). Two defects (7 mm diameter; 10 mm depth; OC punch) were left empty or refilled with osteochondral autologous transplantation cylinders (OATS) and explanted after six weeks. Incision-to-suture time, anesthesia time, and postoperative wound or impairment scores were compared to those in sham-operated animals. Implant performance was assessed by X-ray, micro-computed tomography, histology, and immunohistology (collagens 1, 2; aggrecan). There were no surgery-related infections or patellar luxations. Operation, anesthesia, and time to complete stand were short (0.5, 1.4, and 1.5 h, respectively). The wound trauma score was low (0.4 of maximally 4; day 7). Empty-defect and OATS animals reached an impairment score of 0 significantly later than sham animals (7.4 and 4.0 days, respectively, versus 1.5 days). Empty defects showed incomplete healing and dedifferentiation/heterotopic differentiation; OATS-filled defects displayed advanced bone healing with remaining cartilage gaps and orthotopic expression of bone and cartilage markers. Minimally-invasive, medial parapatellar surgery of OC defects on the sheep MFC allows rapid and low-trauma recovery and appears well-suited for implant testing.
The paper provides an application of the IBESS approach to the investigation of the influence of various parameters of the global and local weld geometry as well as material defects on the fatigue strength of weldments. For this purpose, the global weld parameters, such as the weld toe radius, the flank angle, the excess weld metal, local secondary notches (in the present study as a measure of surface imperfections) and inclusions sizes have been determined as statistical distributions for different joint types and geometries and two steels of different strengths. The results are in line with literature data and reveal the potential of the theoretical approach to predict the correct trends. The combination with an advanced weld quality system has been demonstrated to be possible.
The acronym IBESS stands for "Integrale Bruchmechanische Ermittlung der Schwingfestigkeit von Schweißverbindungen" which, translated from German, means "integral fracture mechanics determination of the fatigue strength of welds". the method introduced in this study is the outcome of a German Research cluster in which eight partners were involved. A list of them is found at the end this study. The IBESS method is characterized by a number of partially novel aspects and elements of fracture mechanics applied to the evaluation of fatigue stength of welds. The most important ones are: (a) Determination of fatigue crack propagation for mechanically/physically short and long cracks. (b) Determination of an elastic-plastic crack driving force for the treatment of mechanically short cracks. To that purpose an analytical expression for the cyclic J-integral was developed and validated against finite element results. (c) The gradual build-up of the crack closure phenomenon is determined by using cyclic R-curves which describe the crack size dependency of the fatigue crack propagation threshold in the physically short crack growth regime. (d) A physically meaningful initial crack size is defined for total life consideration. It is based on a two-criteria approach. Based on a cyclic R-curve analysis, the crack size at crack arrest is determined as a lower bound. If, however, a pre-existing crack-like defect is larger than this, its dimensions define the initial crack size. (e) Multiple crack propagation at the weld toe is considered. (f) In conjunction with this, the variation of the weld toe geometry is considered in a stochastic model. (g) As a result, both the fatigue limit (defined for 107 loading cycles) and the finite life (high cycle) fatigue S-N curve are obtained statistically. (h) At various analysis steps, parametric equations have been developed which allow for analytical calculations instead of complete stochastic analyses based on finite elements which are unrealistic even at present. (i) The method has been validated with a large number of S-N curves including two materials, three weldment types with two geometries, each referring to differnt manufacturing technologies and the as-welded and stressrelieved state. (j) Althrough not finally solved, an extended discussion is provided on the issue of welding residual stresses including their redistribution under cyclic loading. (k) A number of simplifications is proposed at lower analyses levels which, however, partly lack complete validation by now.
This book provides a comprehensive and thorough guide to those readers who are lost in the often-confusing context of weld fatigue. It presents straightforward information on the fracture mechanics and material background of weld fatigue, starting with fatigue crack initiation and short cracks, before moving on to long cracks, crack closure, crack growth and threshold, residual stress, stress concentration, the stress intensity factor, J-integral, multiple cracks, weld geometries and defects, microstructural parameters including HAZ, and cyclic stress-strain behavior. The book treats all of these essential and mutually interacting parameters using a unique form of analysis.
Highly soluble 9,10-dihydro-9-oxa-10-phosphaphenanthrene-10-oxide-(DOPO)-based diamino hardener (2), bearing its amino groups directly on the DOPO framework, is investigated with respect to its use as a reactive flame retardant in thermosets. A mechanism for decomposition of the corresponding phosphorus-modified epoxy resin system based on a diglycidylether of bisphenol A DGEBA and 2 (DGEBA/2) is proposed and compared to the systems using DGEBA and 4,4'-diaminodiphenylsulfon (DGEBA/DDS) and to a similar system based on the structurally comparable non-reactive DOPO-based compound (DGEBA/DDS/1). Additive 1 changed the decomposition characteristics of the epoxy resin only slightly and phosphorus was released. Incorporating 2 induces two-step decomposition and most of the phosphorus remains in the residue. Furthermore, the fire behaviour of neat epoxy resin systems and a representative carbon fibre-reinforced composite based on DGEBA, DDS and 2 (DGEBA/DDS/2) were examined and compared to that of the analogous composite systems based on DGEBA/DDS and DGEBA/DDS/1. Based on different flame retardancy mechanisms both the reactive compound 2 and the additive compound 1 improve flammability (increase in LOI >13% and achieving V-1 behaviour) of the epoxy resin and composites. Under forced flaming only the flame inhibition of the additive compound 1 acts sufficiently. Lastly, the superior key mechanical properties of the epoxy resin and composite based on 2 are sketched.
Summary: The decomposition of novel phosphorus-containing poly(oxyphenylene-sulfonyl-phenylene-oxy-diphenyl phenylene phosphine oxide) (PSU_I), 2,5-dihydroxy-1-biphenylene-phosphine oxide based polysulfone (PSU_II), poly(sulfonyl-diphenylphenylene phosphonate) (PSU_P) and bisphenol A-based polysulfone (PSU) is studied. The influence of the chemical structure, charring and phosphorus release is discussed based on the mass loss, kinetics and products. The pyrolysis and fire behaviour of blends with epoxy resin (EP) are studied. For EP-PSU_II, phosphorus initiates water elimination and changes the decomposition pathway of EP. The fire behaviour of EP-PSU shows some improvements, whereas the heat release rate is crucially reduced for EP-PSU_II due to simultaneous char formation and flame inhibition.
A comparative evaluation of systematically tailored chemical structures of various phosphorus-containing aminic hardeners for epoxy resins was carried out. In particular, the effect of the oxidation state of the phosphorus in the hardener molecule on the curing behavior, the mechanical, thermomechanical, and hot-wet properties of a cured bifunctional bisphenol-A based thermoset is discussed. Particular attention is paid to the comparative pyrolysis of neat cured epoxy resins containing phosphine oxide, phosphinate, phosphonate, and phosphate (with a phosphorus content of about 2.6 wt %) and of the fire behavior of their corresponding carbon fiber-reinforced composites. Comparatively faster curing thermosetting system with an enhanced flame retardancy and adequate processing behavior can be formulated by taking advantage of the higher reactivity of the phosphorus-modified hardeners. For example, a combination of the high reactivity and of induced secondary crosslinking reactions leads to a comparatively high Tg when curing the epoxy using a substoichiometric amount of the phosphinate-based hardener. The overall mechanical performance of the materials cured with the phosphorus-containing hardeners is comparable to that of a 4,4-DDS-cured reference system. While the various phosphorus-containing hardeners in general provide the epoxy-based matrix with enhanced flame retardancy properties, it is the flame inhibition in the gas phase especially that determines the improvement in fire retardancy of carbon fiber-reinforced composites. In summary, the present study provides an important contribution towards developing a better understanding of the potential use of such phosphorus-containing compounds to provide the composite matrix with sufficient flame retardancy while simultaneously maintaining its overall mechanical performance on a suitable level.
Starting from trivalent 10-alkoxy-10H-9-oxa-10-phosphaphenanthrenes, a broad range of DOPO derivatives was synthesized via transesterification with aliphatic alcohols and subsequent Michaelis-Arbuzov rearrangement using catalytic amounts of p-toluenesulfonic acid methylester. Due to the considerable differences in the nature of the alcohols employed, several procedures for processing them are presented.
10-Ethyl-9-oxa-10-phosphaphenanthrene-10-oxide (1) can be nitrated using acetic anhydride and fuming nitric acid. The nitro group is reduced using palladium on charcoal and hydrogen. These reaction conditions are used for the synthesis of an analogous DOPO-based diaminic hardener (7). An evaluation of the curing behavior, mechanical properties and flammability of a neat resin made of DGEBA and 7 (DGEBA + 7) and of a carbon fiber-reinforced resin made of DGEBA, 4,4-diaminodiphenylsulfon (DDS) and 7 (DGEBA + DDS + 7) shows the potential of this hardener to lead to flame-retardant systems while keeping relevant properties on a high level; especially when compared to a similar system (DGEBA + DDS + 1).