Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04754087

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

Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
Zimmer Biomet · Industry
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed 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).

Conditions

Interventions

TypeNameDescription
DEVICEVivacit-E and Longevity (HXLPE) LinersThis is a dual cohort study in which 150 subjects will receive the Vivacit-E (HXLPE) Liner and 150 subjects will receive the Longevity (HXLPE) Liner.

Timeline

Start date
2021-07-07
Primary completion
2033-12-31
Completion
2033-12-31
First posted
2021-02-15
Last updated
2025-06-18

Locations

11 sites across 5 countries: United States, Denmark, Netherlands, Sweden, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT04754087. Inclusion in this directory is not an endorsement.