Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes

A Comprehensive Clinical, Scientific, and Regulatory Guide

von Hafez Selim Md

360 Seiten, Taschenbuch

Kurzbeschreibung des Verlags

Which bone graft is best? That is usually the wrong question.The more useful questions are: Which biological and mechanical properties does this specific defect require? Does the proposed graft provide those properties? How strong is the evidence-and what safety burden accompanies its use?Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes provides a practical, evidence-based framework for answering these questions. Written by physician-scientist and medical-device safety expert Dr. Hafez Selim, this comprehensive reference integrates bone biology, biomaterials science, clinical evidence, product safety, regulatory pathways, and real-world implementation.Inside, readers will find: - Detailed profiles of autografts, allografts, demineralized bone matrices, cellular bone matrices, xenografts, calcium-phosphate ceramics, cements, bioactive glass, synthetic composites, BMPs, PDGF products, P-15 peptides, marrow concentrates, and platelet-based therapies- Application-specific guidance for spine surgery, fractures, nonunion, segmental defects, foot and ankle procedures, dental and maxillofacial grafting, oncologic reconstruction, infection, and special populations- Structured methods for evaluating clinical effectiveness, adverse effects, donor-transmission risks, traceability, recalls, and post-market safety signals- Clear explanations of United States and European regulatory pathways-and why regulatory authorization should never be mistaken for clinical proof- Worked clinical vignettes, selection algorithms, evidence-appraisal checklists, comparison tables, a master material matrix, and a consolidated safety signal register- Practical guidance for patient optimization, shared decision-making, procurement, operating-room handling, documentation, outcome reporting, and institutional product review- An interactive companion tool that helps translate patient and defect characteristics into a required graft-property profileRather than treating every product within a material class as interchangeable, this book emphasizes exact formulation, processing, dose, carrier, indication, comparator, and clinical endpoint. It also identifies where evidence is strong, where extrapolation is inappropriate, and where uncertainty must be clearly communicated.With a foreword by Dr. Mohamed Attawia, this book is designed for orthopaedic, spine, foot-and-ankle, dental, and maxillofacial clinicians; trainees; biomaterials scientists; product-development engineers; medical safety and regulatory professionals; researchers; and hospital value-analysis teams.A rigorous and practical guide for anyone responsible for selecting, evaluating, developing, purchasing, monitoring, or regulating bone graft materials.Evidence reviewed through August 2, 2026.

• Reihe: Independently published
• ISBN: 9798176063691
• Sprache: Englisch
• Erscheinungsdatum: 21.09.2026
• Größe: 279 x 216 mm
• Verlag: Independently published