Total Hip ArthroplastyNCT04754087
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
A study testing Vivacit-E and Longevity (HXLPE) Liners in people with Total Hip Arthroplasty and Degenerative Joint Disease of Hip, run by Zimmer Biomet at 11 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty, Degenerative Joint Disease of Hip, Avascular Necrosis of Hip
- What is being tested?
- Vivacit-E and Longevity (HXLPE) Liners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 7 Jul 2021to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United States6 sites
Colorado Joint Replacement
Denver, Colorado, 80210
Duke University Medical Center
Durham, North Carolina, 27703
Slocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, 97401
Oregon Health and Science University
Portland, Oregon, 97239
University of Utah Health
Salt Lake City, Utah, 84112
South Bend Orthopaedics
South Bend, Indiana, 46635
Netherlands2 sites
Zuyderland Hospital
Geleen, 6162 BG
OCON Hengelo
Hengelo
United Kingdom1 site
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
Bournemouth, UK, BH7 7DW
About this study
Official title: Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation
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.
Read the detailed description
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).
- Conditions
- Total Hip Arthroplasty, Degenerative Joint Disease of Hip, Avascular Necrosis of Hip, Rheumatoid Arthritis of Hip, Osteoarthritis, Hip, Osteoarthritis of Hip
- Being tested
- Vivacit-E and Longevity (HXLPE) Liners
- Medical subject headings
- Osteoarthritis, Hip, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivacit-E and Longevity (HXLPE) LinersDevice
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 group | Role | What they receive |
|---|---|---|
| G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners | Other | Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up. Receives: Device: Vivacit-E and Longevity (HXLPE) Liners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the study device (liner); whether or not it is still implanted in the subject
Survivorship will be based on revision or intended revision of the study device (liner).
Measured: At 10 years
Adverse Event (safety)
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Measured: At 10 years
Secondary outcomes (4)
Pain and Function using Modified Harris Hip Score
Pain and function will be measured using the Modified Harris Hip Score self assessment. The overall score runs from 0-100 with 100 representing the best outcome.
Measured: At 10 years
Pain and Function using Oxford Hip Score
Pain and function will be measured using the Oxford Hip Score self assessment. The overall score runs from 0-48 with 48 representing the best outcome.
Measured: At 10 years
Patient Quality of Life using EQ-5D-5L Descriptive System
Perceived qualify of life will be measured using the EQ-5D-5L Descriptive System - comprises mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each question in this section has an overall score of 1-5 with 1 representing the best health.
Measured: At 10 years
Patient Quality of Life using EQ-5D-5L EQ visual analogue scale
Perceived qualify of life will be measured using the EQ visual analogue scale (EQ VAS) - records the respondent's self-rated health on a vertical, visual analogue scale. This section has an overall score of 0-100 with 100 representing the best health.
Measured: At 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start7 Jul 2021
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754087
- Sponsor's protocol ID
- CMG2019-32H
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation
- ClinicalTrials.gov ID
- NCT04754087
- Acronym / sponsor ID
- CMG2019-32H
- Conditions
- Total Hip Arthroplasty, Degenerative Joint Disease of Hip, Avascular Necrosis of Hip, Rheumatoid Arthritis of Hip, Osteoarthritis, Hip, Osteoarthritis of Hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners | Other | Device: Vivacit-E and Longevity (HXLPE) LinersUp to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivacit-E and Longevity (HXLPE) LinersThis 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. | Device | G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners |
Primary outcome
Survival of the study device (liner); whether or not it is still implanted in the subject
Time frame: At 10 years
Survivorship will be based on revision or intended revision of the study device (liner).
Adverse Event (safety)
Time frame: 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.
4 secondary outcomes
Pain and Function using Modified Harris Hip Score
Time frame: At 10 years
Pain and Function using Oxford Hip Score
Time frame: At 10 years
Patient Quality of Life using EQ-5D-5L Descriptive System
Time frame: At 10 years
Patient Quality of Life using EQ-5D-5L EQ visual analogue scale
Time frame: At 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillary Overholser study director
Zimmer Biomet
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivacit-E and Longevity (HXLPE) Liners in people with Total Hip Arthroplasty and Degenerative Joint Disease of Hip, run by Zimmer Biomet at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Netherlands, Denmark, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the study device (liner); whether or not it is still implanted in the subject (time frame: At 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.