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
Zimmer Biomet
300 participants
Jul 7, 2021
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
Inclusion Criteria9
- 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 Criteria10
- 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.
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT04754087