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G7 Acetabular System with Vivacit-E or Longevity Liner Study

This study is looking at the long-term safety and benefits of two different hip replacement liners, the Vivacit-E and Longevity (HXLPE) Liners, when used with the G7 Acetabular Shells. These liners are used in total hip replacement surgery for conditions like osteoarthritis, rheumatoid arthritis, or avascular necrosis (bone tissue death due to lack of blood supply) of the hip. The study aims to see how well these liners stay in place and if they cause any problems over 10 years. You might be able to join if you are an adult needing a total hip replacement for one of the listed conditions. The study is currently unclear on its recruitment status.

Study design
This study is designed as a dual-cohort study, meaning 150 participants will receive the Vivacit-E liner and 150 will receive the Longevity liner, for a total of 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years to assess the survival of the implanted device and any adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04754087

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Zimmer Biomet
~300 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Vivacit-E and Longevity (HXLPE) Liners

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival of the study device (liner); whether or not it is still implanted in the subject
Measured over At 10 years
+1 more outcome measured

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

Explore related trials

Hip FractureOsteoarthritisOsteonecrosis of hipRheumatoid Arthritis

Where it's being run

11 sites across 9 states
Oregon2
Netherlands2
Colorado1
Indiana1
North Carolina1
Utah1
Denmark1
Sweden1

Study leadership

  • Hillary Overholser · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient must be a legal adult who has reached full skeletal maturity.
Patient must be treated for one of the following indications:
Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
Revision procedures where other treatment or devices have failed
Patient must be able and willing to complete the protocol required follow-up visits.
Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent.

Exclusion

Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.
Patient has a metabolic disorder that may impair bone formation.
Patient has osteomalacia.
Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.
Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease
Patient is a prisoner.
Patient is a current alcohol or drug abuser.
Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
Patient is pregnant.

What this trial measures

  • Survival of the study device (liner); whether or not it is still implanted in the subjectAt 10 years

    Survivorship will be based on revision or intended revision of the study device (liner).

  • Adverse Event (safety)At 10 years

    Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.