Developed in partnership with the American Academy of Orthopaedic Surgeons (AAOS) and edited by internationally renowned experts Drs. Scott P. Bruder and Roy K. Aaron, Orthobiologics: Scientific and Clinical Solutions for Orthopaedic Surgeons provides authoritative, comprehensive coverage of this fast-growing field. This one-stop reference is an ideal resource, covering technology and basic science through specific clinical applications. Covers the basic science clinicians need to know to understand the mechanisms of action of orthobiologic therapies for tissue repair and regeneration, as well as technology development, regulation, and the commercialization pathway Provides thorough discussions of current standards of care and clinical applications across all subspecialty areas, including upper and lower extremity pathology, as well as spinal pathology Uses a reader-friendly approach with more than 100 illustrations and dozens of helpful tables throughout Discusses options and solutions for intervertebral disc repair, spinal fusion, rotator cuff repair, peripheral nerve regeneration in the hand, challenging bone repairs and nonunion, skeletal muscle repair, meniscal repair and replacement, articular cartilage repair, knee and ankle osteoarthritis, ligament regeneration, and more. Enrich Your eBook Reading Experience
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Editorial Board v Contributors vii Foreword xiii Acknowledgments xv Introduction xvii PART 1: Foundational Principles Section 1: Biologic Options for Tissue Repair and Regeneration Section Editors: Robert E. Guldberg, PhD; Edward M. Schwarz, PhD; Christopher H. Evans, PhD 1 Cell Biology and Cell Sources ........................................................................5 Frank Barry, PhD; Mary Murphy, PhD, DSc 2 Materials Science and Biodegradable Scaffolds ........................................................17 Kenneth S. Ogueri, BS, MSc, PhD; Kevin Grassie, BS; Yusuf Khan, PhD; Cato T. Laurencin, MD, PhD, FAAOS 3 Bioactive Factors and Designer Molecules ............................................................33 Vicki Rosen, PhD 4 Gene Therapy ....................................................................................43 Steven C. Ghivizzani, PhD; Christopher H. Evans, PhD 5 Clinically Applicable and Translatable Animal Models in Orthobiologic Research for Cartilage Repair and Osteoarthritis in Humans........................................................61 Laurie Goodrich, DVM, MS, PhD 6 Overview of Orthobiologics for Articular Cartilage Repair ..............................................85 Erica G. Gacasan, MS; Robert L. Sah, MD, ScD 7 Overview of Orthobiologics for Bone Repair .........................................................103 Mirtijn van Griensven, MD, PhD; Elizabeth Rosado Balmayor, PhD 8 Orthobiologics for Tendon and Ligament Repair ..................................................... 119 Hani Awad, PhD; Rahul Alenchery, MSc; Raquel Ajalik, MSc; Victor Z. Zhang, BSc 9 Summary and Perspectives ........................................................................141 Edward M. Schwarz, PhD; Christopher H. Evans, PhD; Robert E. Guldberg, PhD Section 2 Technology Development, Regulation, and the Commercialization Pathway Section Editors: Scott P . Bruder, MD, PhD, FORS; Anthony Ratcliffe, PhD 10 Pitfalls in the Assessment of Outcomes in Randomized Clinical Trials ...................................147 Joseph Harrington, BS; Jennifer Racine- Avila, MBA; Roy K. Aaron, MD, FAAOS, FORS 11 Measuring and Reporting Outcomes................................................................155 Joel J. Gagnier, ND, MSc, PhD; Matthew J. Hadad, MD; Nicolas S. Piuzzi, MD; Evangeline Fumina Kobayashi, MD 12 The US FDA Regulatory Landscape and Compliance..................................................169 Aric Kaiser, MS 13 Product Development ............................................................................185 Lara Ionescu Silverman, PhD; Daniel Rodriguez- Granrose, PhD; Niloofar Farhang, PhD; Angelica Adrian Highsmith, MS 14 Allograft and Xenograft Tissue Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195 Stephen F. Badylak, DVM, PhD, MD; Emily Dianne Henderson, BS 15 Product and Provider Reimbursement in the Field of Orthobiologics ....................................205 Spencer B. Bailey, MBA, CPC 16 Summary and Perspectives ........................................................................215 Anthony Ratcliffe, PhD; Scott P . Bruder, MD, PhD, FORS PART 2: Clinical Applications Section 3: Solutions for Upper Extremity Pathology Section Editors: Kathleen A. Derwin, PhD; Adam Yanke, MD, PhD, FAAOS 17 Rotator Cuff Repair...............................................................................223 Scott A. Rodeo, MD, FAAOS; Janice Havasy, BS, MD; Claire D. Eliasberg, MD; Camila B. Carballo, PhD, PT 18 Tendon Management, Protection, and Repair ........................................................233 Allan Mishra, MD, FAAOS; Michael W. Heffner, MD; Christopher Frey, MD 19 Fresh Fracture, Challenging Bone Repair, and Nonunions .............................................245 J. Tracy Watson, MD, FAAOS 20 Peripheral Nerve Regeneration in the Hand .........................................................265 Minh Hoang Nguyen, MD; Amy M. Moore, MD; Ryan W. Schmucker, MD 21 Skeletal Muscle Regeneration ......................................................................277 George J. Christ, PhD; Brian C. Werner, MD, FAAOS; Sarah E. Dyer, BS; Shep Hurwitz, MD, FAAOS 22 Measurement of Clinical Outcomes in the Upper Extremity ............................................293 Vahid Entezari, MD, MSc; Jason C. Ho, MD; Joseph P . Iannotti, MD, PhD, FAAOS; Kathleen A. Derwin, PhD; Eric T. Ricchetti, MD, FAAOS 23 Summary and Perspectives ........................................................................305 Adam Yanke, MD, PhD, FAAOS; Kevin Credille, BSE, MS; Mario Hevesi, MD, PhD; Kathleen A. Derwin, PhD Section 4: Solutions for Lower Extremity Pathology Section Editors: Robert H. Brophy, MD, FAAOS; Regis J. O’Keefe, MD, PhD, FAAOS 24 Segmental Defect Repair and Nonunion............................................................. 311 Joseph T. Patterson, MD; Jay R. Lieberman, MD, FAAOS 25 Meniscal Repair and Replacement ..................................................................327 Suhas P . Dasari, MD; Safa Gursoy, MD, PhD; Robert F . LaPrade, MD, PhD, F AAOS; Jorge Chahla, MD, PhD 26 Articular Cartilage Repair—Cells and Biomaterials ...................................................345 Michael J. Sayegh, MD; Daniel A. Grande, PhD; Nicholas A. Sgaglione, MD, FAAOS; Kenneth R. Zaslav, MD, FAAOS 27 Knee and Ankle Osteoarthritis—Injectables ..........................................................359 Hannah Bradsell, BS; Rachel M. Frank, MD, FAAOS 28 Ligament Repair and Regeneration .................................................................369 Natalie L. Leong, MD, FAAOS; Jie Jiang, PhD 29 Clinical Outcomes in the Hip and Knee Following Arthroplasty ........................................381 Caroline Taber, AB; Robert G. Marx, MD, FAAOS; Alissa J. Burge, MD 30 Biologic Considerations for Clinical Study Design: Cartilage Repair.........................391 James L. Cook, DVM, PhD; David P . Trofa, MD; Clayton W. Nuelle, MD, FAAOS; Clark T. Hung, PhD 31 Summary and Perspectives ...........................................401 Robert H. Brophy, MD, FAAOS; Regis J. O’Keefe, MD, PhD, FAAOS Section 5: Solutions for Spinal Pathology Section Editors: Wellington K. Hsu, MD, FAAOS; Kevin C. Baker, PhD 32 Intervertebral Disk Repair and Regeneration—Bioactive Factors and Cell- Based Therapy ..................407 Koichi Masuda, MD; Koji Akeda, MD, PhD; Kenji Kato, MD, PhD; Jordy Schol, MSc; Daisuke Sakai, MD, PhD 33 Spine Fusion—Bioactive Factor Based...............................................................435 Hyun W. Bae, MD; Michael Eng, MD; Linda E. A. Kanim, MA; Justin D. Cohen, MD; Juliane Glaeser, PhD; Julie L. Chan, MD, PhD 34 Measurement of Clinical Outcomes in Spine .........................................................469 Athan G. Zavras, BA, MD; Ishan Agarwal, BS; Bryce A. Basques, MD; Frank M. Phillips, MD, FAAOS 35 Biologic Considerations for Clinical Study Design: Fusion .............................................479 S. Raymond Golish, MD, PhD, MBA, FAAOS 36 Summary and Perspectives ........................................................................487 Kevin C. Baker, PhD; Wellington K. Hsu, MD, FAAOS Index ...............................................................................................489
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