Total Hip ArthroplastyDegenerative Joint Disease of HipAvascular Necrosis of HipRheumatoid Arthritis of HipOsteoarthritis, HipOsteoarthritis of HipFractures, HipFracture of Hip
Investigational drug(s) / intervention(s)
Vivacit-E and Longevity (HXLPE) Liners
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Survival of the study device (liner); whether or not it is still implanted in the subject — At 10 years Survivorship will be based on revision or intended revision of the study device (liner).
Adverse Event (safety) — At 10 years Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Trial sites (11)
Facility
City
Region
Status
Colorado Joint Replacement
Denver
Colorado
South Bend Orthopaedics
South Bend
Indiana
Duke University Medical Center
Durham
North Carolina
Slocum Center for Orthopedics & Sports Medicine
Eugene
Oregon
Oregon Health and Science University
Portland
Oregon
University of Utah Health
Salt Lake City
Utah
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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