Orthobiologics

Contents
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