Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

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