G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
Recruiting
N/AInterventional Study
Total Hip ArthroplastyDegenerative Joint Disease of HipAvascular Necrosis of HipRheumatoid Arthritis of HipOsteoarthritis, HipOsteoarthritis of HipFractures, HipFracture of Hip
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Zimmer Biomet · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 …
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.
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