NCT04754087 G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
| NCT ID | NCT04754087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zimmer Biomet |
| Condition | Total Hip Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-07-07 |
| Primary Completion | 2033-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-07-07 with a primary completion date of 2033-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Hillary Overholser
STUDY DIRECTOR
Zimmer Biomet
Frequently Asked Questions
Who can join the NCT04754087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Total Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04754087 currently recruiting?
Yes, NCT04754087 is actively recruiting participants. Contact the research team at wendy.hatcher@zimmerbiomet.com for enrollment information.
Where is the NCT04754087 trial being conducted?
This trial is being conducted at Denver, United States, South Bend, United States, Durham, United States, Eugene, United States and 7 additional locations.
Who is sponsoring the NCT04754087 clinical trial?
NCT04754087 is sponsored by Zimmer Biomet. The principal investigator is Hillary Overholser at Zimmer Biomet. The trial plans to enroll 300 participants.