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أخواني في الله أحضرت لكم كتاب PEEK Biomaterials Handbook Edited by Steven M. Kurtz
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Table of contents Dedication Foreword List of Contributors Chapter 1. An Overview of PEEK Biomaterials 1.1. Introduction 1.2. What Is a Polymer? 1.3. What Is PEEK? 1.4. Crystallinity and PEEK 1.5. Thermal Transitions 1.6. PEEK Composites 1.7. Overview of This Handbook Chapter 2. Synthesis and Processing of PEEK for Surgical Implants 2.1. Introduction 2.2. Synthesis of PAEKs 2.3. Nomenclature 2.4. Quality Systems for Medical Grade Resin Production 2.5. Processing of Medical Grade PEEK 2.6. Machining 2.7. Summary Chapter 3. Compounds and Composite Materials 3.1. Introduction 3.2. What Is a Composite Material? 3.3. Additive Geometry, Volume, and Orientation Effects 3.4. Preparation of Materials 3.5. Processing to Make Parts 3.6. Biocompatibility of CFR PEEK 3.7. Summary and Conclusions Chapter 4. Morphology and Crystalline Architecture of Polyaryletherketones 4.1. Introduction 4.2. Chain Architecture and Packing 4.3. Crystallization Behavior 4.4. Characterization Techniques 4.5. Structure Processing–Property Relationships 4.6. Summary and Conclusions Chapter 5. Fracture, Fatigue, and Notch Behavior of PEEK 5.1. Introduction 5.2. Fracture and Fatigue of Materials 5.3. PEEK Fracture Studies 5.4. PEEK Notch Studies 5.5. Summary Chapter 6. Chemical and Radiation Stability of PEEK 6.1. Introduction to Chemical Stability 6.2. Water Solubility 6.3. Thermal Stability 6.4. Steam Sterilization of PEEK 6.5. Radiation Stability: Implications for Gamma Sterilization and Postirradiation Aging 6.6. Summary Chapter 7. Biocompatibility of Polyaryletheretherketone Polymers 7.1. Introduction 7.2. Cell Culture and Toxicity Studies 7.3. Mutagenesis (Genotoxicity) 7.4. Immunogenesis 7.5. Soft Tissue Response 7.6. Osteocompatibility of PEEK Devices 7.7. Biocompatibility of PEEK Particulate—X-STOP PEEK Explant Studies 7.8. Summary and Conclusions Chapter 8. Bacterial Interactions with Polyaryletheretherketone 8.1. Introduction 8.2. Bacterial Adhesion to Biomaterials 8.3. The Role of Surface Topography and Chemistry in Bacterial Adhesion 8.4. Strategies to Reduce Bacterial Adhesion to PEEK 8.5. Summary and Perspectives Chapter 9. Thermal Plasma Spray Deposition of Titanium and Hydroxyapatite on Polyaryletheretherketone Implants 9.1. Introduction 9.2. Coating Technology 9.3. Biomedical Plasma-Sprayed Coatings 9.4. Coating Analysis Methods 9.5. Substrate Analysis Method 9.6. Plasma-Sprayed Coatings on PEEK-Based Substrates 9.7. Plasma-Sprayed Osteointegrative Surfaces for PEEK: The Eurocoating Experience 9.8. Summary and Conclusions Chapter 10. Surface Modification Techniques of Polyetheretherketone, Including Plasma Surface Treatment 10.1. PEEK–Tissue Interactions 10.2. Surface Modification 10.3. Surface Modification Techniques 10.4. Applications of These Surface Modification Methods and the Translation to Industry 10.5. Perspectives Chapter 11. Bioactive Polyaryletherketone Composites 11.1. Introduction 11.2. Processing–Structure Relationships 11.3. Structure–Property Relationships 11.4. Concluding Remarks Chapter 12. Porosity in Polyaryletheretherketone 12.1. Introduction 12.2. Porous Biomaterials in Existing Implants 12.3. Porous Polymer Production for Industrial Applications 12.4. Manufacturing of Porous PEEK Biomaterials 12.5. Case Study 1—Porosity Through Porogen Leaching at Production Scale 12.6. Case Study 2—Comparison of Small and Large Pore Sizes 12.7. Case Study 3—Mid-Sized Porosity 12.8. Conclusions Chapter 13. Applications of Polyaryletheretherketone in Spinal Implants 13.1. Introduction 13.2. Origins of Interbody Fusion and the “Cage Rage” of the Late 1990s 13.3. CFR-PEEK Lumbar Cages: The Brantigan Cage 13.4. Threaded PEEK Lumbar Fusion Cages 13.5. Clinical Diagnostic Imaging of PEEK Spinal Cages and Transpedicular Screws 13.6. Subsidence and Wear of PAEK Cages 13.7. Posterior Dynamic Stabilization Devices 13.8. Cervical and Lumbar Artificial Discs 13.9. Summary Chapter 14. Isoelastic Polyaryletheretherketone Implants for Total Joint Replacement 14.1. Introduction 14.2. Incompatible Design Goals for an Uncemented Hip Stem 14.3. Setbacks with Early Polymer–Metal Composite Hip Stems 14.4. The Epoch Hip Stem 14.5. Other PAEK Composite Hip Stems 14.6. Stress Shielding in the Acetabulum 14.7. PEEK in the Acetabulum 14.8. Outlook for PEEK in Orthopedic Implants Chapter 15. Applications of Polyetheretherketone in Trauma, Arthroscopy, and Cranial Defect Repair 15.1. Introduction 15.2. Principles of Fracture Repair 15.3. Principles of Arthroscopic Repair 15.4. Principles of Craniofacial Defect Repair 15.5. Summary Chapter 16. Arthroplasty Bearing Surfaces 16.1. Introduction 16.2. Total Hip and Knee Replacement 16.3. Basic Biotribology Studies of PEEK Articulations 16.4. Hip Resurfacing 16.5. Mobile-Bearing, Unicondylar Knee Joint Replacements 16.6. Other Total Joint Replacement Applications 16.7. MOTIS: Medical Grade CFR-PEEK for Bearing Applications 16.8. Summary and Concluding Remarks Chapter 17. FDA Regulation of Polyaryletheretherketone Implants 17.1. Introduction 17.2. What Is the FDA? 17.3. Common Misconceptions About What the FDA Does 17.4. Brief History of the FDA 17.5. Medical Device Definition and Classification 17.6. Regulatory Approval Process and Types of Applications 17.7. Content of an FDA Application 17.8. Material Considerations 17.9. Current Uses of PEEK in FDA-Approved Spinal and Orthopedic Implants 17.10. The Use of Master Files in Supplying Material Data for FDA Regulation 17.11. The Use of Standards in FDA Regulation 17.12. Summary and Conclusions Index Index A ABG II total hip system trials, 265e6 Adhesins, 97e8 Adhesion see Bacterial adhesion. Anchors, PEEK, 251e4 Anterior lumbar interbody fusion (ALIF), 206 Arthroplasty bearing surfaces: about the bearing surfaces, 261, 272 finger joint replacement, 271e2 see also Biotribology studies of PEEK articulations; Hip and knee replacement; Hip resurfacing Arthroscopic repair, 249e51 about arthroscopic repair, 249e50 anchor materials: historic, 250 PEEK anchors, 251 PEEK interference screws and fixators, 251 PEEK suture anchors, 251e4 Artificial discs, 24e5 ASTM standard specification for PEEK, 291 Atmospheric plasma spraying (APS), 122 Atomic force microscopy (AFM) evaluation, 154 Autoclaving, PEEK, 76 B Bacterial adhesion, reduction strategies for PEEK, 103e8 antiadhesive surfaces, 104 antibacterial surfaces, 104e5 antimicrobials, 105 incorporation of antibiotics into biomaterials, 105e6 vancomycin surfaces, 105 use of silver, 106 use of silver-PEEK composites, 106e8 Bacterial interactions and adhesion to biomaterials, 93e109 about adhesion and PEEK, 108e9 about bacteria, 95e6 about bacterial interactions, 93 biomaterials and infection, 94e5 host immune response, role of, 103 nonspecific adhesion, 96e7 electrostatic forces, 96e7 Lewis acid-base forces, 96e7 Lifshitz-van der Waals forces, 96e7 specific adhesion, 97e8 adhesins, 97e8 surface chemistry, influence of, 101e3 with bacterial interactions, 101e3 oxygen plasma treatment, 102 protein interactions, 101 wettability, 101e2 topography, influence of, 98e101 about this influence, 98 benefits of smooth surfaces, 99 effects of manufacturing method, 98e9 nanotopographies, 99e101 BAK cage, 203 Barium sulfate X-ray absorber, 30 BHC stem, 224 Bioactive PAEK composites, 163e74 about the composites, 163e4, 174 bioactive reinforcement, 164e8 composite manufacturing, 168e70 cold pressing and pressureless sintering, 168 compounding and injection molding, 168 compression molding, 168e9 heat treatment, 170 processing temperatures, 170 quantitative microstructural characterization, 170 SLS, 169 tailored macroporosity, 169 PAEK and calcium phosphate combinations, 163e4, 167 PAEK synthesis and structure, 164 processing-structure relationships, 164e70 summary of investigation, 165e6 Bioactive PAEK composites, properties, 170e4 biological properties, 170e2 calcium phosphate properties, 171 cell attachment with fibroblasts, 171 HA-reinforcement, 171 osteoconductivity and osteointegration, 171 solubility product, 171 functional properties, 172 mechanical properties, 172e4 evaluation, 172 HA-reinforced PEEK, 172e3 micromechanical models, 173 porous PEKK and PEEK scaffolds, 174 tension fatigue, 173e4 Biocompatibility of PEEK polymers, 81e91 about biocompatibility, 81e2, 91 cell culture/toxicity studies, 82e3 CFR PEEK polymer, 45e6 immunogenesis, 84 mutagenesis (genotoxicity) studies, 84 osteocompatibility of PEEK devices, 84e7 soft tissue response, 84 see also Explant studies with PEEK particulate Biomedical plasma-spray see Thermal plasma spray deposition Biotribology studies of PEEK articulations, 266e9 articulating against ceramic, 267e8 articulating against themselves, 267e8 Austin et al. aggressive loading evaluations, 268 lubricant issue, 267 pin-on-discs tests, 268e9 pin-on-plate apparatus, 266e7 ring-on-plate tests, 268 rubbing against metallic counterfaces, 267e8 293Bone adaptation, 221 Bone ongrowth, 130e1 Bradley hip/stem, 23, 230 Brantigan lumbar cage, 203e7 C Cage rage, 203 Cambridge cup, 232e4, 269 Carbon fiber-reinforced PEEK (CFR PEEK) polymer, 23e5 biocompatibility, 45e6 and computer tomography (CT), 24e5 continuous CFR PEEK, 34e6, 37e8 lumber cages, 203e7 and MRI, 24 short CFR PEEK, 32e4, 36e7 and X-rays, 24 see also Composite materials Carbon fibers, 28 manufacture, 28 tensile strength, 29 Carbon-UHMWPE Poly II composites problems, 262e3 Cell culture/toxicity studies, PEEK, 82e3 Center for Devices and Radiological Health (CDRH): and the FDA, 277e8, 284, 290 guidance by, 124, 125e7 Cervical and lumbar artificial discs, 24e5 CFR-PEEK see Carbon fiberreinforced PEEK (CFR PEEK) polymer Characterization techniques, PAEK polymers, 52e7 about the techniques, 52 density gradient, 53 differential scanning calorimetry (DSC), 56 FTIR spectroscopy, 55 microscopy, 56e7 x-ray diffraction, 53e5 Charpy impact toughness, 62, 64e5 Chemical stability of PEEK, 75 Chemical structure of PEEK, PEK and PEKK, 2e3 Classification by FDA of medical devices, 281e2 Coating analysis, 124e9 ASTM requirements, 124e7 Center for Devices and Radiological Health (CDRH) guidance, 124, 125e7 see also Substrate analysis Coating technology, 120e2 thermal spray coatings, 120 see also Thermal plasma spray deposition Cold plasma surface modification, 150 Composite materials: about CFR PEEK polymer, 23e5 about compounds and composite materials, 25e6 about PEEK composites, 4e5 fiber: carbon fibers, 28, 29 reinforcement principle, 26 role of, 27e8 fiber length effects, 32 fiber/matrix interface, 28e30 strength of, 30 matrix, role of, 26e7 PEEK polymer matrix, 27 naturally occurring, 25 powder additive for image contrast, 30e2 barium sulphate, 30e1 PEEK-OPTIMA mechanical properties, 31 wire marker alternative, 31 relation between fiber length, volume fraction and processing, 33 volume fraction issues, 32 see also Bioactive PAEK composites Composite materials, processing for parts, 38e45 processing of CFR PEEK: filament winding, 41e2 hot forming, 42e4 hot pressing and autoclave molding, 40e1 machining, 44e5 pultrusion, 41 processing of compounds, 38e40 extrusion, 39e40 injection molding, 38e9 Composites of PEEK, 4e5 Compounds, about compounds and composite materials, 25e6 Compression molding: Bioactive PAEK composites, 168 of PEEK, 19e20 Computer tomography (CT), and CFR PEEK, 24e5 Continuous CFR PEEK material, 34e6 definition, 34 ENDOLIGN, 35e6 manufacturing process, 37e8 interleaving, 38 using pre-impregnated fibrous material, 38 mechanical properties, 34 processing: filament winding, 41e2 hot forming, 42e4 hot pressing and autoclave molding, 40e1 pultrusion, 41 Corona surface modification, 149 Craniofacial defect repair, 251e7 about craniofacial defects, 251e2 historical implant materials, 252e6 alloplastic implants, 255 high-density polyethylene (HDPE), 255 Hydroxyapatite (HA), 255 metallic implants, 256 polymethyl methacrylate (PMMA), 253e5 PEEK cranial implants: about the implants, 256 clinical studies, 256e7 current landscape, 257 Crystal unit cells, all PAEK polymers, 50e1 unit cell dimensions, 51 Crystallinity of PEEK, 3 Crystallite morphology, all PAEK polymers, 51e2 Crystallization behavior, all PAEK polymers, 52 D Density gradient characterization, 53 Development history of PEEK, 1 Differential scanning calorimetry (DSC): measurements/characterization, 4, 56 with substrate analysis, 129 Direct osteointegration, 119 Dynamic synovial fluid, 147 Dynesys explants/system, 212 E Electron beam surface modification, 149 Electrophillic routes to synthesis of PAEK polymers, 9e11 ENDOLIGN, 35e6 Epoch hip stem, 224e30 Epoch I, 225e9 Explant studies with PEEK particulate, 87e91 overal rating, 90e1 retrieval analysis, 87 X-STOP PEEK IPD System, 87 Extrusion compounding, 36e7 Extrusion of PEEK, 18e19, 20, 39e40 barrel capacity and residence time, 40 barrel temperatures, 40 drive motors, 40 screw design, 40 F Fatigue crack propagation (FCP), 63 see also Fracture and fatigue of materials 294 INDEXFDA (Food and Drug Administration), 277e92 about the FDA, 277e8, 291e2 Center for Devices and Radiological Health (CDRH), 277e8, 290 main responsibilities, 277e8 premarket approval, 278 similar organizations in UK, Australia and Japan, 277 brief history, 279e81 common misconceptions, 278e9 expanding the indications, 278 indications for use, 278 PEEK approval, 278 who tests?, 279 Master Files, 288e9 medical device definition and classification, 281e2 IBFD (cages) example, 281e2 spinal implants approvals, 202 standards, use by FDA, 289e91 ASTM standard specification for PEEK, 291 benefits and limitations, 290e1 material specifications, 289 standard test guides, 289 standard test methods, 289 standards development process, 290 FDA, applications material, 284e6 acceptance criteria of manufacturer, 286 efficacy and effectiveness, 285 failure modes, 285 performance specifications, 285 risk analysis, 285 safety, 285 substantial equivalence to existing devices, 286 Traditional 510(k) submissions, 284 valid scientific evidence requirement, 284 FDA, current PEEK approvals, 287e8 intervertebral body fusion devices (IBFD), 287e8 spinal fusion rods, 288 vertebral body replacements (VBR), 288 FDA, regulatory approval process, 282e4 CDRH involvement, 284 device listing, 282 establishment registration, 283 exempt devices, 282, 283 Investigation Device Exemption (IDE), 283 Investigation Review Boards (IRBs), 284 materials used issues, 286e7 biocompatibility, 287 functionality testing, 286e7 predicates, 283 premarket approval applications (PMAs), 283e4 premarket notification process, 283, 284 review times, 284 substantially equivalent devices, 283 Fiber reinforcement principle, 26 Fibronectin, 145 Filament winding, 41e2 Fillers, effects on structure and properties, 58 Film and fiber production of PEEK, 20e1 PEEK monofilament production, 21 Finger joint replacement, 271e2 Fixators, PEEK, 251 Flame surface modification, 148e9 Food and Drug Administration see FDA Fourier transform infrared spectroscopy (FT-IR), 128 Fracture and fatigue of materials, 61e4 fatigue crack propagation (FCP), 63 impact testing, 62 notches, 63e4 stress intensity factor K, 61e2 stress life testing, 62e3 Fracture repair, 243e9 about fracture repair, 243e4 Carter’s theory, 245 Gardner et al., stress fields, 245 mechanical stability, 244e6 PEEK for trauma applications, 247e9 about Peek for trauma, 247e8 current landscape for PEEK, 248e9 limitations, 248 as locking devices to bone plates, 249 radiolucent property, 248 primary healing, 244 resorption, 244 secondary healing, 244 semirigid fixation plates, 246e7 choice of materials, 246e7 CRF-PEEK Snake Plate, 247 flexual fatigue and thermoformability, 247 ‘optically amorphous PEEK, 247 stress shielding after healing, 246 Wolff’s Law, 246 Fracture studies, PEEK, 64e6 fractography and fracture micromechanisms, 65e8 mechanical properties, 64e5 Charpy impact toughness, 64e5 fatigue crack growth (FCG), 64e5 fracture toughness, 64e5 see also Notch studies, PEEK FTIR spectroscopy characterization, 55 Fusion see Spinal implants with PEEK G Gamma sterilization safety, PEEK, 76e7 Genotoxicity (mutagenisis) studies, PEEK, 84 Graf ligament system, 212 H High-pressure forming, 43 Hip and knee replacement, 261e6 carbon-UHMWPE Poly II composites problems, 262e3 CFR-PEEK composites: ABG II total hip system trials, 265e6 alumina as femoral head material, 265 early evaluations/comparisons, 261e2, 263e4 superior wear performance of UHMWPE, 266 Wang et al. tribological investigation, 264 wear debris issues, 265e6 wear performance issues, 264e5 Zirconia withdrawal from market, 265 see also Biotribology studies of PEEK articulations Hip resurfacing, 269e71 Cambridge cup, 269 MITCH PCR horseshoe cup, 269e71 Hot forming, 42e4 composite flow molding, 42 high-pressure forming, 43e4 Hot plasma surface modification, 149e50 Human osteoblast (HOB) tests, 154e5 Hydroxyapatite (HA) coatings, 122e3 I Immunogenesis, 84 Impact testing, 62 Charpy impact test, 62 Injection molding of PEEK, 16e18 crystallinity issues, 18 for fiber reinforced materials, 17 molds for, 16e17 temperatures required, 17e18 Interference screws , PEEK, 251 Interspinous process spacers (ISPs), 210e12 X-STOP systems, 210e11 INDEX 295Intervertebral body fusion devices (IBFD), FDA PEEK approval, 287e8 Ion beam surface modification, 149 Isoelastic PEEK implants, 221e38 about isoelastic PEEK implants, 221e38 BHC stem, 224 bone adaptation, 221 Bradley stem, 230 CFR-PEEK in the acetabulum, 233e6 Cambridge cup, 233e6 MITCH Cup-PCR, 233e7 early setbacks, 223e4 Epoch hip stem, 224e30 Epoch I, 225e9 outlook for PEEK, 236e8 Physiologic Stem, 230 requirements for uncemented hip stems, 222e3 RMI stem, 224 stress shielding in the acetabulum, 230e3 bone loss, 231 Cambridge cup, 232 cementless cups, 231 long-term clinical consequences, 231 periproshetic bone changes, 231 K Knee joint replacement: unicondylar mobile-bearing design, 271 see also Hip and knee replacement L Laser surface modification, 149 Lumbar and cervical artificial discs, 24e5 M Machining PEEK, 21 Magnetic resonance imaging (MRI), and CFR PEEK, 24 Master Files, use by FDA, 288e9 Matrix, role of, 26e7 PEEK polymer matrix, 27 MG PEEK-OPTIMA processing, 15e21 about MG resin quality systems, 14e15 about PEEK material for processing, 15e16 compression molding, 19e20 extrusion, 18e19 film and fiber production, 20e1 injection molding, 16e18 machining, 21 see also PEEK-OPTIMA biomaterials Microscopy characterization, 56e7 MITCH PCR horseshoe cup, 234e7, 269e71 Morphology, all PAEK polymers, 50 Motis (pitch-based CFR-PEEK OPTIMA), 119, 272 Mutagenesis (genotoxicity) studies, PEEK, 84 N Notches, 63e4 notch studies, PEEK, 66e71 Von Mises (VM) stress, 67e8 see also Fracture and fatigue of materials; Fracture studies, PEEK NUBAC intradiscal arthroplasty device, 214e15 Nucleophillic routes to synthesis of PAEK polymers, 11e12 NUNEC cervical all-PEEK TDR, 215 O OPTIMA biomaterials see PEEKOPTIMA biomaterials Osseoconductivity, 190e2 Osteocompatibility of PEEK devices, 84e7 Osteoconductive surfaces, 119e20 Oxygen plasma surface modification, 152e6 atomic force microscopy (AFM) evaluation, 154 effects of washing, 152e3 human osteoblast (HOB) tests, 154e5 mineralization, 155e6 scanning electro microscopy (SEM) roughness checks, 154 stability investigations, 153e4 P PAEK polymers: about PAEK polymers, 1e2, 58e9 crystal unit cells, 50e1 crystallite morphology, 51e2 crystallization behavior, 52 fillers, effects on structure and properties, 58 morphology, 50 polymer backbone, 49e50 temperature, effects on structure and properties, 57e8 thermal transitions, 57 see also Characterization techniques, PAEK polymers; Synthesis of PAEK polymers Pedicle-based posterior stabilization (PEEK Rods), 211 PEEK (polyaryletheretherketone): about PEEK, 1, 2e3 available forms, 3 chemical structure, 2e3 composites, 4e5 crystallinity, 3 development history, 1 UHMWPE, 3 see also Composites of PEEK; Thermal transitions of PEEK PEEK interference screws and fixators, 251 PEEK rod posterior lumbar fusion system, 212e14 clinical relevance evaluation, 213e14 creep and degradation benefits, 212 fatigue testing, 212e13 PEEK suture anchors, 251e4 PEEK-OPTIMA biomaterials, 13e14, 16 LT1, LT2, and LT3, 14 for processing, 16 properties, 14 quality systems, 14e15 see also Carbon fiber-reinforced PEEK (CFR PEEK) polymer; MG PEEK-OPTIMA processing PEKK (Polyetherketoneketone), 2 PEKs (Polyetherketones), 2 Physiologic Stem, 230 Plasma-sprayed osteointegrative surfaces for PEEK, 131e9 about Eurocoating’s experience, 131 coating characterization, 131e5 hydroxyapatite coating, 132 Spondycoat, 131e2 substrate characterization, 132e9 fatigue investigations, 133e9 thermal properties, 133 UV degradation, 132 Polyaryletheretherketone see PEEK Polyaryletherketone polymers see Bioactive PAEK composites PAEK polymers Polyetherketoneketone (PEKK), 2 Polyetherketones (PEKs), 2 Polymers, 2 copolymers, 2 definition, 2 homopolymers, 2 linear and branched polymers, 2 Polymethyl methacrylate (PMMA), 253e5 Porogen leaching for porosity see Porosity in PEEK case studies 296 INDEXPorosity in PEEK, 181e97 about porosity in PEEK, 181e2, 196e7 applications, medical, 181 manufacture for medical use, 184e7 evaluation issues, 184 heat sintering, 185e6 micromachining, 186 microwave sintering, 186 particulate leaching, 184e5 PEEK textiles, 186e7 selective laser sintering, 186 porous polymers in industry, 183e4 using amorphous sulfonated PEEK-WC, 184 using chemical blowing agents, 183 using gas-assisted injection molding, 183 using nitrogen saturation technology, 184 using Victrex, 183e4 Porosity in PEEK, case studies: mid-sized porosity, 194e7 compressive strength implications, 196e7 process method, 194e5 pore sizes comparisons, 192e5 compressive strength comparisons, 194e5 with trabecular bone porosity, 192e3 porogen leaching, 187e92 about the study on PEEKOPTIMA, 187e8, 190e2 bone ongrowth quantification, 189 cortical sites, 189 histology, 189e90 mechanical testing, 188 osseoconductivity, 190e2 pore size issues, 191e2 in vitro testing, 188e9 in vivo study, 189 Porous biomaterials in existing implants, 182e3 in craniomaxillofacial (CMF) applications, 182e3 limitations, 183 in spinal and orthopedic applications, 182 Posterior dynamic stabilization devices, 210e14 about the devices, 210 Dynesys explants/system, 212 Graf ligament system, 212 interspinous process spacers (ISPs), 210e12 pedicle-based posterior stabilization (PEEK Rods), 211 PEEK rods, 212e14 Primary fracture healing, 244 Pultrusion, 41 Q Quality systems for PEEKOPTIMA, 14e15 Quantitative microstructural characterization, 170 R Radiation stability, PEEK, 76e8 gamma sterilization safety, 76e7 postirradiation aging, 78 Resorption in fracture repair, 244 RMI stem, 224 S Scanning electro microscopy (SEM) roughness checks, 154 Screws and fixators: PEEK extrusion, 40 PEEK interference for arthroscopic repair, 251 transpedicular, 208e9 Secondary fracture healing, 244 Short CFR PEEK material, 32e4 extrusion compounding, 36e7 manufacturing process, 33 mechanical properties, 33e4 Shrouded plasma spray (SPS), 122 Soft tissue response, to PEEK, 84 Solubility product, 171 Spinal fusion rods, FDA PEEK approvals, 288 Spinal implants with PEEK, 201e16 about spinal implants and fusion, 201e2, 215e16 BAK cage, 203 cage rage, 203 cervical and lumbar artificial discs, 214e15 NUBAC device, 214e15 NUNEC cervical all-PEEK TDR, 215 CFR-PEEK lumber cages, 203e7 anterior lumbar interbody fusion (ALIF), 206 Brantigan cage, 203e7 fusion results, 205e6 testing and evaluation, 204e5 clinical diagnostic imaging, 208e9 CRF-PAEK, PEEK and PEKEKK tests/evaluations, 204e6 Food and Drug Administration (FDA) approval, 202 interbody fusion, history, 202e3 subsidence and wear of PAEK/PEEK cages, 209e10 threaded PEEK lumbar fusion cages, 207e8 total disc replacements (TDRs), 202 transpedicular fixing/screws, 208e9 see also Posterior dynamic stabilization devices Spondycoat, 131e2 Sputter coating surface modification, 149 Stability of PEEK, 75e8 chemical stability, 75 radiation stability, 76e8 with steam sterilization, 76 thermal stability, 76 water solubility, 75 Standards, use by FDA regulation, 289e91 Steam sterilization, PEEK, 76 Stress intensity factor K, 612 Stress life testing, 62e3 Stress shielding: about stress shielding, 221 in the acetabulum, 230e3 after fracture healing, 246 Substrate analysis, 127e9 differential scanning calorimetry (DSC), 129 Fourier transform infrared spectroscopy (FT-IR), 128 test specimens, 127e8 x-ray photoelectron spectroscopy (XPS), 128 Surface energy and PEEK, 145e6 Surface modification of PEEK, 145e56 biological criteria, 147e8 dynamic synovial fluid, 147 fibroblasts, 148 inflammation process, 147 chemical criteria, 148 chain length, 148 surface orientation, 148 thickness, 148 PEEK surface structure and chemistry, 146e7 PEEK-tissue interactions, 145e6 fibronectin, 145 surface energy and PEEK, 145e6 water-protein activity, 145 surface analytical assessment, 148 Surface modification of PEEK techniques, 148e51 application issues, 151e2 chemical: surface etching, 151 surface grafting, 151 direct physical/chemical, 148e51 INDEX 297Surface modification of PEEK techniques (Continued) cold plasma, 150 corona, 149 electron beam, 149 flame, 148e9 hot plasma, 149e50 ion beams, 149 laser, 149 sputter coating, 149 UV/ozone, 150e1 oxygen plasma surface modification, 152e6 Synthesis of PAEK polymers, 9e12 electrophillic routes, 9e11 nomenclature, 12e14 summary of PAEK materials used for implants, 13 nucleophillic routes, 11e12 OPTIMA PEEK biomaterials, 13e14 VESTAKEEP implantable grade PEEK, 14 Victrex PEEK (ICI), 13 Zeniva implantable grade PEEK, 14 T Temperature effects on structure and properties of PAEK/PEEK, 57e8 Thermal plasma spray deposition, 119e39 about the devices/technology, 120e2 atmospheric plasma spraying (APS), 122 biomedical plasma-sprayed coatings, 122e4 hydroxyapatite (HA) coatings, 122e3 Ti-HA coatings, 123e4 titanium (Ti) coatings, 122 coatings on PEEK-based substrates, 129e31 about the coatings, 129 adhesion strength improvements, 130 bone ongrowth, 130e1 HA coating with APS, 130 UV irradiation issues, 130 plasma spray devices/technology, 120e2 plasma spray parameters, 121e2 shrouded plasma spray (SPS), 122 vacuum plasma spraying (VPS), 122 see also Coating analysis Thermal stability, PEEK, 76 Thermal transitions of PEEK, 3e4, 57 about transitions for PAEK and PEEK, 57 DSC measurements, 4 flow temperature, 3e4 glass transition temperature, 3e4 melt temperature, 3e4 Threaded PEEK lumbar fusion cages, 207e8 Ti-HA coatings, 123e4 Titanium coatings, 122 Total disc replacements (TDRs), 202, 215 Total joint replacement see Isoelastic PEEK implants Toxicity/cell culture studies, PEEK, 82e3 Transpedicular fixing/screws, 208e9 U UHMWPE (ultra-high-molecularweight polythene), 3 carbon filled, problems with, 29e30 for hip and knee replacement, 262e3, 266 Unicondylar knee joint replacement, 271 UV irradiation with Plasma coatings, 130 UV/ozone surface modification, 150e1 V Vacuum plasma spraying (VPS), 122 Vancomycin-tethered surfaces, 105 Vertebral body replacements (VBR), FDA PEEK approval, 288 VESTAKEEP implantable grade PEEK, 14 Victrex PEEK (ICI), 13 Von Mises (VM) stress, 67e8 W Water solubility, PEEK, 75 Wolff’s Law on fracture repair, 246 X X-ray diffraction characterization, 53e5 small-angle x-ray (SAXS), 55 wide-angle x-ray (WAXS), 53e5 X-ray photoelectron spectroscopy (XPS), 128 X-rays, and CFR PEEK, 24 X-STOP: ISPs, 210e11 PEEK IPD System, 87 Z Zeniva implantable grade PEEK, 14 Zirconia, withdrawal from market
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