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

Running, not enrolling · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04754087

Run by

Zimmer Biomet

People needed

300

Starts

2021-07-07

Expected to finish

2033-12-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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