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ACTIVE NOT RECRUITINGNA

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

Sponsor: Zimmer Biomet

NCT ID: NCT04754087

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Vivacit-E and Longevity (HXLPE) Liners (device)
How long the study runs
Study runs about 149 months (dates as stated)
About the drug or intervention
Vivacit-E and Longevity (HXLPE) Liners — device: 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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
300
Started
2021-07-07
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for total hip arthroplasty
  • • NA - 300 participants
  • • 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 can take part?

  • • Ages 18 Years and over
  • • Diagnosed with total hip arthroplasty

Where?

  • • Bournemouth - The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

More detail

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

Total Hip ArthroplastyDegenerative Joint Disease of HipAvascular Necrosis of HipRheumatoid Arthritis of HipOsteoarthritis, HipOsteoarthritis of HipFractures, HipFracture of Hip

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ follow-up visits

What the study is looking for

  • ✓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

Who cannot take part

  • ✗Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's...
  • ✗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...
  • ✗Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
See the full 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 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.

Where Is This Study? (1 UK site)

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital

Bournemouth BH7 7DW, United Kingdom

Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200
Data sourced from ClinicalTrials.gov · Last verified: 2026-07