G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

Status Recruiting

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

Clinical Trial Details

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

View Details

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