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

NCT04754087 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-06-18

No results posted yet for this study

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.

Conditions

  • Total Hip Arthroplasty
  • Degenerative Joint Disease of Hip
  • Avascular Necrosis of Hip
  • Rheumatoid Arthritis of Hip
  • Osteoarthritis, Hip
  • Osteoarthritis of Hip
  • Fractures, Hip
  • Fracture of Hip

Interventions

DEVICE

Vivacit-E and Longevity (HXLPE) Liners

This 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.

Sponsors & Collaborators

  • Zimmer Biomet

    lead INDUSTRY

Principal Investigators

  • Hillary Overholser · Zimmer Biomet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2033-12-31
Completion
2033-12-31
FDA Device
Yes

Countries

  • United States
  • Denmark
  • Netherlands
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04754087 on ClinicalTrials.gov