RecruitingNot ApplicableNCT04754087

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


Sponsor

Zimmer Biomet

Enrollment

300 participants

Start Date

Jul 7, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting long-term follow-up data on patients who received a specific type of hip replacement implant system (G7 Acetabular System) to monitor its safety and performance over time. **You may be eligible if...** - You are a legal adult who has reached full physical maturity - You received or are receiving hip replacement surgery for conditions such as osteoarthritis, avascular necrosis, rheumatoid arthritis, hip fracture, or a congenital hip deformity - The specific G7 implant system was used in your procedure **You may NOT be eligible if...** - You have an active infection at or near the hip joint - You have severe bone loss (osteoporosis) that would prevent stable implant fixation - You have conditions making surgery too risky Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVivacit-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.


Locations(11)

Colorado Joint Replacement

Denver, Colorado, United States

South Bend Orthopaedics

South Bend, Indiana, United States

Duke University Medical Center

Durham, North Carolina, United States

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Utah Health

Salt Lake City, Utah, United States

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark

Zuyderland Hospital

Geleen, Netherlands

OCON Hengelo

Hengelo, Netherlands

Skane University Hospital

Lund, Sweden

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital

Bournemouth, UK, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04754087


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