Clinical Evaluation of Medical Devices: Principles and Case Studies Book

	Foreword
	Preface
	Contributors
Pt. I	Fundamentals of Clinical Study Design and Evaluation	1
1	Clinical Trials in Development and Marketing of Medical Devices	3
2	Observational Research: The Nonexperimental Approach	23
3	Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devices	41
4	Regulatory Requirements for Clinical Trials of Medical Devices and Diagnostics	59
Pt. II	Introduction to Case Studies	79
5	Clinical Studies of Prosthetic Heart Valves Using Historical Controls	83
6	Prospective Multicenter Clinical Trials in Orthopedics: Special Concerns and Challenges	103
7	Long-Term Evaluation of Total Hip Arthroplasty	133
8	Injectable Collagen and a Rare Adverse Event - True Association or Artifact?: Results of Postmarket Surveillance Research	151
9	In Vitro Diagnostics: Design of Clinical Studies to Validate Effectiveness	165
10	A Controlled Study of Intra-Articular Hyalgan in the Treatment of Osteoarthritis of the Knee	191
11	Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valves	209
12	Polyurethane Pacemaker Leads: The Contribution of Clinical Experience to the Elucidation of Failure Modes and Biodegradation Mechanisms	233
	Glossary	257
	Index	263