SYMPOSIA PAPER Published: 18 June 2018
STP160620170126

The Need for Standardization, Terminology, and Interfacing Retrieval Analysis with Registries

Source

Many studies of implants that are removed at surgery concentrate on the physical findings obtained from the device itself, neglecting the patient and circumstances of treatment. On the other hand, clinical reviews, case reports, and implant registries tend to focus on the patient and may neglect an engineering description of the device. The recommended analytic approach to the study of retrieved devices is that of the traditional medical case history study, marrying both medical and engineering approaches. A careful accumulation of clinical findings, the development of a working hypothesis involving both the modes and mechanisms for implant behavior, and the use of clinical and engineering test methods to substantiate preliminary impressions will result in a cohesive view of device performance. Standardization of the type and terminology of information collected can help bridge retrieval analyses with clinical registries. This will facilitate the engineering analysis of retrievals, while incorporating patient-level data, so as to better understand patient and clinical factors that may be associated with clinical performance.

Author Information

Ong, Kevin, L.
Exponent, Inc., Philadelphia, PA, US
Chang, Ellen, T.
Exponent, Inc., Menlo Park, CA, US
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Details
Developed by Committee: F04
Pages: 39–48
DOI: 10.1520/STP160620170126
ISBN-EB: 978-0-8031-7658-4
ISBN-13: 978-0-8031-7657-7