A Vigilant Approach for the New Orthopedic Implant Implementation

Nahum Rosenberg^1,2,3

¹I.M. Sechenov First Moscow State Medical University, Moscow, Russia
²Department of Orthopaedic Surgery, Rambam Health Care Campus, Israel
³Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel

Dr. Nahum Rosenberg, IM Sechenov First Moscow State Medical University, Russia. Department of Orthopaedic Surgery, Rambam Health Care Campus and Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Israel.

Keywords: Joint Implant; Orthopedic Surgery; Product Limit Method

Abstract

Joint implants used in arthroplasties are continuously redesigned aiming to achieve higher longevity with lower surgical morbidity. The clinically used implants are usually approved by the regulatory authorities, following standard preclinical and clinical studies. But even following this thorough evaluation, the actual clinical outcome in large populations is not clear and sometimes can cause to devastating failure of the implant that can't be predicted from the initial studies [1]. The risk for such failure of the arthroplasty can't be overemphasized.
In order to evaluate clinical outcome of orthopedic implants, two important and unique characteristics should be addressed - the relatively limited number of patients, below 100 patients in most studies, and the long term of follow up, i.e. usually several years. In orthopedic surgery for joint arthroplasty these requirements might challenge the effectiveness of traditional statistical tools for comparison of medical or surgical treatments, used in other clinical areas, with involvement of large cohorts of patients, with clear short-term outcome, that remains unchanged for long time periods.

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