UHMWPE Biomaterials Handbook

Ultra High Molecular Weight Polyethylene in Total Joint Replacement and Medical Devices

3rd Edition - September 16, 2015

Editor: Steven M. Kurtz

Hardback ISBN:

9 7 8 - 0 - 3 2 3 - 3 5 4 0 1 - 1

eBook ISBN:

9 7 8 - 0 - 3 2 3 - 3 5 4 3 5 - 6

UHMWPE Biomaterials Handbook, Third Edition, describes the science, development, properties, and application of ultra-high molecular weight polyethylene (UHMWPE) used in… Read more

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UHMWPE Biomaterials Handbook, Third Edition, describes the science, development, properties, and application of ultra-high molecular weight polyethylene (UHMWPE) used in artificial joints. UHMWPE is now the material of choice for joint replacements, and is increasingly being used in fibers for sutures. This book is a one-stop reference for information on this advanced material, covering both introductory topics and the most advanced developments.

The third edition adds six new chapters on a range of topics, including the latest in anti-oxidant technologies for stabilizing HXLPE and up-to-date systematic reviews of the clinical literature for HXLPE in hips and knees. The book chronicles the rise and fall of all-metal hip implants, as well as the increased use of ceramic biomaterials and UHMWPE for this application. This book also brings orthopedic researchers and practitioners up to date on the stabilization of UHMWPE with antioxidants, as well as the choices of antioxidant available for practitioners.

The book also thoroughly assesses the clinical performance of HXLPE, as well as alternative bearings in knee replacement and UHMWPE articulations with polyether ether ketone (PEEK).

Written and edited by the top experts in the field of UHMWPE, this is the only state-of-the-art reference for professionals, researchers, and clinicians working with this material.

Dedication
List of Contributors
Foreword
1: A Primer on UHMWPE
- Abstract
- 1.1. Introduction
- 1.2. What is a Polymer?
- 1.3. What is Polyethylene?
- 1.4. Crystallinity
- 1.5. Thermal Transitions
- 1.6. Overview of the Handbook
2: From Ethylene Gas to UHMWPE Component: The Process of Producing Orthopedic Implants
- Abstract
- 2.1. Introduction
- 2.2. Polymerization: from Ethylene Gas to UHMWPE Powder
- 2.3. Conversion: from UHMWPE Powder to Consolidated Form
- 2.4. Machining: from Consolidated Form to Implant
- 2.5. Conclusions
3: Packaging and Sterilization of UHMWPE
- Abstract
- 3.1. Introduction
- 3.2. Gamma Sterilization in Air
- 3.3. Gamma Sterilization in Oxygen Barrier Packaging
- 3.4. Ethylene Oxide Gas Sterilization
- 3.5. Gas Plasma Sterilization
- 3.6. The Torino Survey of Contemporary Orthopedic Packaging
- 3.7. Shelf-Life of UHMWPE Components for Orthopedic Implants
- 3.8. Overview of Current Trends
- Acknowledgments
4: The Origins of UHMWPE in Total Hip Arthroplasty
- Abstract
- 4.1. Introduction and Timeline
- 4.2. The Origins of a Gold Standard (1958–1982)
- 4.3. Charnley’s First Hip Arthroplasty Design with PTFE (1958)
- 4.4. Implant Fixation with Pink Dental Acrylic Cement (1958–66)
- 4.5. Interim Hip Arthroplasty Designs with PTFE (1958–1960)
- 4.6. Final Hip Arthroplasty Design with PTFE (1960–1962)
- 4.7. Implant Fabrication at Wrightington
- 4.8. The First Wear Tester
- 4.9. Searching to Replace PTFE
- 4.10. UHMWPE Arrives at Wrightington
- 4.11. Implant Sterilization Procedures at Wrightington
- 4.12. Overview
- Acknowledgments
5: The Clinical Performance of Historical and Conventional UHMWPE in Hip Replacements
- Abstract
- 5.1. Introduction
- 5.2. Joint Replacements do not Last Forever
- 5.3. Range of Clinical Wear Performance in Cemented Acetabular Components
- 5.4. Wear Versus Wear Rate of Hip Replacements
- 5.5. Comparison of Wear Rates between Different Clinical Studies
- 5.6. Comparison of Wear Rates in Clinical and Retrieval Studies
- 5.7. Current Methods for Measuring Clinical Wear in THA
- 5.8. Range of Clinical Wear Performance in Modular Acetabular Components
- 5.9. Conclusions
- Acknowledgments
6: The Clinical Performance of Highly Cross-linked UHMWPE in Hip Replacements
- Abstract
- 6.1. Introduction
- 6.2. What are First- and Second-Generation HXLPEs?
- 6.3. Clinical Performance of First-Generation HXLPEs in THA
- 6.4. Clinical Performance of Second-Generation HXLPEs in THA
- 6.5. Summary
- Acknowledgments
7: Contemporary Total Hip Arthroplasty: Alternative Bearings
- Abstract
- 7.1. Introduction
- 7.2. Metal-on-Metal (MOM) Alternative Hip Bearings
- 7.3. Ceramics in Hip Arthroplasty
- 7.4. Noise and Squeaking from Hard-on-Hard Bearings
- 7.5. Polyether Ether Ketone (PEEK)
- 7.6. Polycarbonate Urethane (PCU)
- 7.7. Summary
8: The Origins and Adaptations of UHMWPE for Knee Replacements
- Abstract
- 8.1. Introduction
- 8.2. Frank Gunston and the Wrightington Connection to TKA
- 8.3. Polycentric Knee Arthroplasty
- 8.4. Unicondylar Polycentric Knee Arthroplasty
- 8.5. Bicondylar Total Knee Arthroplasty
- 8.6. Patellofemoral Arthroplasty
- 8.7. UHMWPE with Metal Backing
- 8.8. Conclusions
- Acknowledgments
9: The Clinical Performance of UHMWPE in Knee Replacements
- Abstract
- 9.1. Introduction
- 9.2. Biomechanics of Total Knee Arthroplasty
- 9.3. Clinical Performance of UHMWPE in Knee Arthroplasty
- 9.4. Osteolysis and Wear in TKA
- 9.5. Summary
- Acknowledgments
10: Contemporary Total Knee Arthroplasty: Alternative Bearings
- Abstract
- 10.1. Introduction
- 10.2. HXLPE in TKA
- 10.3. Ceramic Bearings in TKA
- 10.4. Summary
11: The Clinical Performance of UHMWPE in Shoulder Replacements
- Abstract
- 11.1. Introduction
- 11.2. The Shoulder Joint
- 11.3. Shoulder Replacement
- 11.4. Contemporary Total Shoulder Replacements
- 11.5. Clinical Performance of Total Shoulder Arthroplasty
- 11.6. Controversies in Shoulder Replacement
- 11.7. Future Directions in Total Shoulder Arthroplasty
- 11.8. Conclusions
- Acknowledgments
12: The Clinical Performance of UHMWPE in Elbow Replacements
- Abstract
- 12.1. Introduction
- 12.2. Anatomy of the Elbow
- 12.3. Elbow Biomechanics
- 12.4. Implant Design
- 12.5. Osteolysis and Wear
- 12.6. Conclusions
- Acknowledgments
13: Applications of UHMWPE in Total Ankle Replacements
- Abstract
- 13.1. Introduction
- 13.2. Anatomy
- 13.3. Ankle Biomechanics
- 13.4. Total Ankle Replacement Design
- 13.5. UHMWPE Loading and Wear in Total Ankle Replacements
- 13.6. Complications and Retrieval Analysis
- 13.7. Conclusions
- Acknowledgments
14: The Clinical Performance of UHMWPE in the Spine
- Abstract
- 14.1. Introduction
- 14.2. The CHARITÉ Artificial Disc
- 14.3. Lumbar Disc Arthroplasty
- 14.4. Cervical Disc Arthroplasty
- 14.5. Wear and In Vivo Degradation of UHMWPE in the Spine
- 14.6. Alternatives to UHMWPE in Disc Replacement
- 14.7. Many Unanswered Questions Remain
- Acknowledgments
15: Highly Cross-Linked and Melted UHMWPE
- Abstract
- 15.1. Introduction
- 15.2. Radiation Cross-Linking
- 15.3. Irradiation and Melting
- 15.4. Effect of Radiation Dose, Melting, and Irradiation Temperature, on UHMWPE Properties
- 15.5. Effect of Cross-Linking on Fatigue Resistance
- 15.6. Optimum Radiation Dose
- 15.7. Hip Simulator Data
- 15.8. Knee Simulator Data
- 15.9. Clinical Follow-Up Studies
- 15.10. In Vivo Changes – Explants
- 15.11. Conclusions
16: Highly Cross-Linked and Annealed UHMWPE
- Abstract
- 16.1. Introduction
- 16.2. Development of Duration Stabilized UHMWPE
- 16.3. Crossfire
- 16.4. X3 – Sequentially Irradiated and Annealed UHMWPE
- 16.5. Conclusions
- Acknowledgments
17: Vitamin E-Blended UHMWPE Biomaterials
- Abstract
- 17.1. Introduction
- 17.2. Vitamin E as an Antioxidant for Polyolefins
- 17.3. Vitamin E Blends in Food Packaging
- 17.4. Vitamin E Studies from Japan
- 17.5. VITASUL and Vitamin E Studies from Austria
- 17.6. Vitamin E Studies from Italy
- 17.7. Vitamin E Blends and Thresholds for Oxidative Stability
- 17.8. Vitamin E Blends and Mechanical Behavior
- 17.9. Vitamin E Blends and Cross-Linking Efficiency
- 17.10. Warm Irradiation and Postirradiation Treatment of Vitamin E Blends
- 17.11. Conclusions
- Acknowledgment
18: Highly Cross-Linked UHMWPE Doped with Vitamin E
- Abstract
- 18.1. Introduction
- 18.2. Function of Vitamin E
- 18.3. Diffusion of Vitamin E in Cross-Linked UHMWPE
- 18.4. Wear
- 18.5. Mechanical and Fatigue Properties
- 18.6. Oxidative Stability
- 18.7. Biocompatibility
- 18.8. Conclusions and Future Prospects
- Acknowledgments
19: Alternate Antioxidants for Orthopedic Devices
- Abstract
- 19.1. Introduction
- 19.2. Historical Perspective
- 19.3. Commercial Listing and Trade Names
- 19.4. Mechanistic Studies on Radical Stabilization
- 19.5. Oxidative Stability Studies
- 19.6. Material Property Characterization
- 19.7. Biocompatibility and Biological Response
- 19.8. Ionizing Radiation Effects on Antioxidants
- 19.9. Antioxidants in Food and Healthcare
- 19.10. Antioxidants in Orthopedic Implants
- 19.11. Conclusions
- Acknowledgment
20: Phospholipid Polymer Grafted Highly Cross-Linked UHMWPE
- Abstract
- 20.1. Articular Cartilage
- 20.2. Surface Modification with Hydrophilic Polymer
- 20.3. PMPC-Grafted Polyethylene for Artificial Hip Joints
- 20.4. Future Perspectives
- Acknowledgments
21: UHMWPE Matrix Composites
- Abstract
- 21.1. Introduction
- 21.2. CFR–UHMWPE Composite: Poly II
- 21.3. CNTs–UHMWPE Composites
- 21.4. Graphene–UHMWPE Composites
- 21.5. Other UHMWPE Matrix Composites For Orthopedic Bearings
- 21.6. Polyethylene–HA Composites
- 21.7. Summary
- Acknowledgments
22: UHMWPE Homocomposites and Fibers
- Abstract
- 22.1. Introduction
- 22.2. UHMWPE Homocomposites
- 22.3. UHMWPE Fibers
- Acknowledgments
23: UHMWPE–Hyaluronan Microcomposite Biomaterials
- Abstract
- 23.1. Introduction
- 23.2. Surface Modification of UHMWPE
- 23.3. Polyurethanes and Hydrogels
- 23.4. Hyaluronan (HA)
- 23.5. Synthesis and Processing of UHMWPE–HA Microcomposites
- 23.6. UHMWPE–HA
- 23.7. Cross-Linked UHMWPE–HA
- 23.8. Cross-Linked Compatibilized UHMWPE–HA
- 23.9. Chemical and Physical Characterization of UHMWPE–HA Biomaterials
- 23.10. UHMWPE–HA Composition
- 23.11. UHMWPE–HA Hydrophilicity
- 23.12. UHMWPE–HA Biostability
- 23.13. UHMWPE Crystallinity in UHMWPE–HA
- 23.14. Mechanical and Tribological Characterization of UHMWPE–HA Biomaterials
- 23.15. Sterilization of UHMWPE–HA Biomaterials
- 23.16. Biocompatibility of UHMWPE–HA Biomaterials
- 23.17. Commercialization of UHMWPE–HA Biomaterials
- 23.18. Conclusions
- Acknowledgments
24: High Pressure Crystallized UHMWPEs
- Abstract
- 24.1. Introduction
- 24.2. Extended Chain Crystallization
- 24.3. Hylamer
- 24.4. Cross-Linking Followed by High Pressure Crystallization
- 24.5. High Pressure Crystallization Followed by Cross-Linking
- 24.6. Summary
- Acknowledgments
25: Compendium of HXLPEs
- Abstract
- 25.1. Introduction
- 25.2. AltrX™
- 25.3. AOX™
- 25.4. ArCom XL Polyethylene
- 25.5. Crossfire
- 25.6. Durasul®
- 25.7. E1 Polyethylene
- 25.8. Longevity
- 25.9. Marathon
- 25.10. Prolong
- 25.11. Vivacit-E
- 25.12. X3
- 25.13. XLK
- 25.14. XLPE
- Acknowledgments
26: Mechanisms of Cross-Linking, Oxidative Degradation, and Stabilization of UHMWPE
- Abstract
- 26.1. Introduction
- 26.2. Mechanism of Macroradicals Formation During Irradiation
- 26.3. Mechanism of Cross-Linking
- 26.4. UHMWPE Oxidation
- 26.5. Critical Products of Oxidation Process – Macroradicals
- 26.6. Critical Products of the Oxidation Process: Oxidized Products
- 26.7. Stabilization UHMWPE
- 26.8. Consideration on Industrial Cross-Linking and Sterilization of Prosthetic Components
- 26.9. In vivo Absorption of Lipids
- 26.10. Chemical Properties of Wear Debris
- Acknowledgments
27: In Vivo Oxidation of UHMWPE
- Abstract
- 27.1. Introduction
- 27.2. Perspective of In Vivo Oxidation in the 1980s to the Present
- 27.3. Experimental Techniques for Studying In Vivo Oxidation
- 27.4. Clinical Significance of In Vivo Oxidation
- 27.5. Laboratory Simulation of In Vivo Oxidation
- 27.6. Summary and Conclusions
- Acknowledgments
28: Pathophysiologic Reactions to UHMWPE Wear Particles
- Abstract
- 28.1. Introduction
- 28.2. Rationale for Evaluating Tissue Responses
- 28.3. Immune System
- 28.4. Immunologic Responses to Joint Replacement UHMWPE Wear Debris
- 28.5. In Vitro and In Vivo Models Used to Study the Immune Response to UHMWPE Wear Debris
- 28.6. Inflammatory and Noninflammatory Histopathologic Changes in Periprosthetic Tissues that Promote Heterotopic Ossification and/or Osteolysis
- 28.7. Current Considerations Based on More Recent Findings and Approaches to Tissue Analysis
- 28.8. Exacerbation of the Immune Response to Wear Debris as a Result of Subclinical Infection
- 28.9. HXLPE and Histopathophysiologic Changes in Periprosthetic Hip Tissues from Implant Retrievals
- 28.10. Conclusions
- Acknowledgments
29: Characterization of Physical, Chemical, and Mechanical Properties of UHMWPE
- Abstract
- 29.1. Introduction
- 29.2. What does the FDA Require?
- 29.3. Physical Property Characterization
- 29.4. Chemical Property Characterization
- 29.6. Antioxidant Measurements
- 29.7. Accelerated Aging
- 29.8. Wear Testing
- 29.9. Conclusions
30: Wear Assessment of UHMWPE with Pin-on-Disc Testing
- Abstract
- 30.1. Introduction
- 30.2. Considerations and Pitfalls for POD Testing of UHMWPE
- 30.3. Development of POD Testing
- 30.4. International Standardization of POD Testing (ASTM F732)
31: Tribology of UHMWPE in the Hip
- Abstract
- 31.1. Introduction
- 31.2. Tribology
- 31.3. Hip Joint Simulators
- 31.4. Quantification of Wear and Surface Measurements
- 31.5. International Standards
- 31.6. Clinical Validation of Hip Simulators
- 31.7. Summary
32: Tribological Assessment of UHMWPE in the Knee
- Abstract
- 32.1. Introduction
- 32.2. Testing UHMWPE within Whole TKR Systems
- 32.3. Considerations and Pitfalls in Knee Wear Testing of UHMWPE
- 32.4. Concluding Remarks and Future Directions in UHMWPE and TKR Longevity Test Methods
33: Characterization of UHMWPE Wear Particles
- Abstract
- 33.1. Introduction
- 33.2. Rationale for Wear Particle Isolation
- 33.3. Delipidization of Samples
- 33.4. Alkali Digestion of Periprosthetic Tissues and Simulator Lubricants
- 33.5. Acid Digestion of Periprosthetic Tissues and Simulator Lubricants
- 33.6. Enzyme Digestion of Periprosthetic Tissues and Simulator Lubricants
- 33.7. Silicon Wafer Display Protocol
- 33.8. Centrifugation of Samples
- 33.9. Filtering to Recover Particles
- 33.10. Polarised Light Microscopy of Tissue Samples
- 33.11. Scanning Electron Microscopy Analysis
- 33.12. Atomic Force Microscopy
- 33.13. Image Analysis of UHMWPE Wear Particles
- 33.14. Automated Particle Analysis
- 33.15. Standards
- 33.16. Particle Measurements (Size/Shape Descriptors)
- 33.17. Predicting Functional Biological Activity
- 33.18. Antioxidant Additives to UHMWPE
- 33.19. Conclusions
- Acknowledgments
34: Clinical Surveillance of UHMWPE Using Radiographic Methods
- Abstract
- 34.1. Introduction
- 34.2. Early Manual Methods for Radiographic Measurement
- 34.3. Radiostereometric Analysis
- 34.4. Non-RSA Methods
- 34.5. Other Factors to Consider
35: ESR Insights into Macroradicals in UHMWPE
- Abstract
- 35.1. Introduction
- 35.2. Basic Principle of ESR
- 35.3. Free Radicals in UHMWPE
- 35.4. Long-Lived Radicals in UHMWPE
- 35.5. Intermediate Radicals in UHMWPE
- 35.6. Vitamin E-Doped UHMWPE
- 35.7. Application of ESR for Quantitative Measure of Free Radicals in UHMWPE
- Acknowledgments
36: Fatigue and Fracture of UHMWPE
- Abstract
- 36.1. Introduction
- 36.2. Fatigue Resistance
- 36.3. Fracture Resistance
37: Development and Application of the Notched Tensile Test to UHMWPE
- Abstract
- 37.1. Introduction
- 37.2. Overview of Notch Behavior
- 37.3. Part I: Monotonic Tension Studies
- 37.4. Part II: Notched Fatigue Life Studies
- 37.5. Conclusions and Future Directions
38: Development and Application of the Small Punch Test to UHMWPE
- Abstract
- 38.1. Introduction
- 38.2. Overview and Metrics of the Small Punch Test
- 38.3. Accelerated and Natural Aging of UHMWPE
- 38.4. In Vivo Changes in Mechanical Behavior of UHMWPE
- 38.5. Effect of Cross-linking on Mechanical Behavior and Wear
- 38.6. Shear Punch Testing of UHMWPE
- 38.7. Fatigue Punch Testing of UHMWPE
- 38.8. Conclusions
39: Computer Modeling and Simulation of UHMWPE
- Abstract
- 39.1. Introduction
- 39.2. Overview of Available Modeling and Simulation Approaches
- 39.3. Characteristic Material Behavior of UHMWPE
- 39.4. Material models for UHMWPE
- 39.5. Discussion
- Acknowledgments
40: Nano- and Microindentation Testing of UHMWPE
- Abstract
- 40.1. Introduction
- 40.2. Depth-Sensing Indentation Testing Methods
- 40.3. Indentation Tests on UHMWPE: Structure–Property Testing
- 40.4. Nanoscratch Single Asperity Wear Tests and Their Effects on Indentation Behavior
- 40.5. Conclusions
- Acknowledgment
41: MicroCT Analysis of Wear and Damage in UHMWPE
- Abstract
- 41.1. Introduction
- 41.2. MicroCT Scanning
- 41.3. Evaluation of Penetration in THA using Geometric Primitives
- 41.4. Evaluation of Penetration in Nonregularly Shaped Components
- 41.5. Assessing Subsurface Cracking using microCT
- 41.6. Using microCT to Visualize Third Body Wear
- 41.7. Conclusions
- Acknowledgments
Subject Index