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Clinical Trial Summary

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.


Clinical Trial Description

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04754087
Study type Interventional
Source Zimmer Biomet
Contact Wendy J Hatcher
Phone 574-549-4281
Email wendy.hatcher@zimmerbiomet.com
Status Recruiting
Phase N/A
Start date July 7, 2021
Completion date December 31, 2033

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