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Clinical Trial Summary

To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.


Clinical Trial Description

The purpose of this study is to provide clinical evidence for the safety and effectiveness of Ortho Development® Corporation's Entrada™ Hip System (Figure 1). The Entrada™ Hip System was fully introduced to the US market in July, 2018. The Entrada™ Hip System includes the Entrada™ Hip Stem, an FDA approved (510(K) # K171249) femoral stem coupled with either a cobalt chrome or Biolox® Delta Ceramic femoral head. Additionally, the stem and head are coupled with either the Escalade® or Legend® acetabular shell, both of which utilize highly cross-linked polyethylene liners. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04277416
Study type Observational
Source Ortho Development Corporation
Contact
Status Enrolling by invitation
Phase
Start date February 28, 2020
Completion date December 31, 2032

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