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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200