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Clinical Trials in the UK / NCT04754087
Active, not recruiting Not applicable

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

NCT04754087 · tracked via the Priya Life Science UK tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2021-07-07
Last updated
2026-07-16

Condition(s) studied

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)

Trial sites (11)

FacilityCityRegionStatus
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 Bournemouth UK

More Zimmer Biomet trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT04754087 on ClinicalTrials.gov ↗ ← All trials in the UK