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Clinical Trial Summary

The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.


Clinical Trial Description

Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries.

This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03986918
Study type Observational
Source Ortho Development Corporation
Contact Samantha Andrews, PhD
Phone 8085224822
Email samantha.andrews@straub.net
Status Recruiting
Phase
Start date June 1, 2019
Completion date June 30, 2024

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