Hip OsteoarthritisNCT05548972
G7 Dual Mobility With Vivacit-E or Longevity PMCF
A study testing G7 Dual Mobility with Vivacit-E bearing and G7 Dual Mobility Longevity bearing in people with Hip Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 10 sites in 4 countries.
Trial summary
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases
- What is being tested?
- G7 Dual Mobility with Vivacit-E bearing and G7 Dual Mobility Longevity bearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 20 Mar 2023to Aug 2037
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 to 80 years of age, inclusive
- Patient is skeletally mature
- Patient qualifies for (total) hip arthroplasty based on physical exam and medical history including at least one of the following:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Dislocation risks
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- 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 is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
- Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent
Who cannot join
- Patient is septic, has an active infection or has osteomyelitis at the affected joint
- Patient has significant osteoporosis as defined by treating surgeon
- Patient has metabolic disorder(s) which may impair bone formation
- Patient has osteomalacia
- Patient has distant foci of infections which may spread to the implant site
- Patient has rapid joint destruction, marked bone loss or bone resorption apparent on pre-operative radiographs
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- Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure
- Patient is undergoing simultaneous bilateral THA
- Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which are likely to jeopardize the outcome of the surgery.
- Patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- Patient is known to be pregnant
- The patient is in a vulnerable population group such as:
- a prisoner
- a known alcohol or drug abuser
- mentally incompetent or unable to understand what participation in this study entails
Trial locations and contacts
10 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 4 countries
United States6 sites
The Cleveland Clinic
Cleveland, Ohio, 44195
HCA HealthONE Orthopedic Specialists
Denver, Colorado, 80218
Slocum Research & Education Foundation
Eugene, Oregon, 97401
Jersey City Medical Center
Jersey City, New Jersey, 07302
Bowen Hefley Orthopedics
Little Rock, Arkansas, 72205
Hospital for Special Surgery
New York, New York, 10021
South Korea2 sites
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 58128
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam, 50612
About this study
Official title: Global, Multicenter and Prospective Post-Market Clinical Follow-Up Study of the G7® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty
Read the detailed description
The G7 Dual Mobility construct offers dislocation resistance without the need to constrain the femoral head, providing stability and high range of motion. Dual Mobility systems decrease the risk of post-operative instability in high-risk patients in both primary and revision arthroplasties.
This study will enroll up to 358 hips globally, 179 for the Vivacit-E and 179 for the Longevity polyethylene bearings. From the 179 hips per bearing variant, the study will enroll 60 primary and 119 revision arthroplasty hips. The Longevity bearing variant will only be enrolled in the US, as it is not CE marked and unregistered in the APAC market. Vivacit-E bearings will be enrolled globally.
A maximum of 20 study centers will be selected globally. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target maximum 24 primary hip arthroplasties and maximum 47 revision hip arthroplasties. Each site is encouraged to enroll both, primary and revision, subjects.
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis, Dislocation, Hip, Femoral Neck Fractures
- Being tested
- G7 Dual Mobility with Vivacit-E bearing, G7 Dual Mobility Longevity bearing
- Keywords
- Total Hip arthroplasty, Revision Hip arthroplasty, Medical device, Safety, Performance, Clinical benefit, G7 Dual Mobility
- Medical subject headings
- Osteoarthritis, Hip, Arthritis, Rheumatoid, Joint Diseases, Osteonecrosis, Hip Dislocation, Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G7 Dual Mobility with Vivacit-E bearingDevice
hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
G7 Dual Mobility Longevity bearingDevice
hip arthroplasty with G7 Dual Mobility Longevity bearing
| Study group | Role | What they receive |
|---|---|---|
| G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA | Other | Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60) Receives: Device: G7 Dual Mobility with Vivacit-E bearing |
| G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty | Other | Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119) Receives: Device: G7 Dual Mobility with Vivacit-E bearing |
| G7 Dual Mobility with Longevity polyethylene bearing in primary THA | Other | Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60) Receives: Device: G7 Dual Mobility Longevity bearing |
| G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty | Other | Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119) Receives: Device: G7 Dual Mobility Longevity bearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the implant system
Survival of the implant system based on removal of the study device
Measured: 10 years
Safety of the implant system
Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
Measured: 10 years
Secondary outcomes (4)
Modified Harris Hip Score
The modified Harris Hip Score measures pain, function and functional activities using a self assessment. The overall score runs from 0-100 with 100 representing the best outcome.
Measured: 10 years
Oxford Hip Score
The Oxford Hip Score measures pain and function using a self assessment. The overall score runs from 0-48 with 48 representing the best outcome.
Measured: 10 years
EQ-5D-5L
The EQ-5D-5L measures the quality of life using a self assessment. The questionnaire includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 10 years
Radiographic Assessment
X-ray evaluation to find significant radiographic findings such as radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start20 Mar 2023
- Primary completionJan 2037 (estimated)
- Study completionAug 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548972
- Sponsor's protocol ID
- CMG2020-42H
- Status last verified
- Jun 2025
- First submitted
- 7 Sep 2022
- Last updated
- 15 Jun 2025
- Results posted
- 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 15 Jun 2025. 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® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation
- ClinicalTrials.gov ID
- NCT05548972
- Acronym / sponsor ID
- CMG2020-42H
- Conditions
- Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis, Dislocation, Hip, Femoral Neck Fractures
- Keywords
- Total Hip arthroplasty, Revision Hip arthroplasty, Medical device, Safety, Performance, Clinical benefit, G7 Dual Mobility
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- Jan 2037 (estimated)
- Study completion
- Aug 2037 (estimated)
- First posted
- 22 Sep 2022 (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.
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty
Detailed description
The G7 Dual Mobility construct offers dislocation resistance without the need to constrain the femoral head, providing stability and high range of motion. Dual Mobility systems decrease the risk of post-operative instability in high-risk patients in both primary and revision arthroplasties.
This study will enroll up to 358 hips globally, 179 for the Vivacit-E and 179 for the Longevity polyethylene bearings. From the 179 hips per bearing variant, the study will enroll 60 primary and 119 revision arthroplasty hips. The Longevity bearing variant will only be enrolled in the US, as it is not CE marked and unregistered in the APAC market. Vivacit-E bearings will be enrolled globally.
A maximum of 20 study centers will be selected globally. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target maximum 24 primary hip arthroplasties and maximum 47 revision hip arthroplasties. Each site is encouraged to enroll both, primary and revision, subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA | Other | Device: G7 Dual Mobility with Vivacit-E bearingSubjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60) |
| G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty | Other | Device: G7 Dual Mobility with Vivacit-E bearingSubjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119) |
| G7 Dual Mobility with Longevity polyethylene bearing in primary THA | Other | Device: G7 Dual Mobility Longevity bearingSubjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60) |
| G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty | Other | Device: G7 Dual Mobility Longevity bearingSubjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is 18 to 80 years of age, inclusive
- Patient is skeletally mature
- Patient qualifies for (total) hip arthroplasty based on physical exam and medical history including at least one of the following:
- Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent
- Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent
Key exclusion criteria (15 listed)
- Patient is septic, has an active infection or has osteomyelitis at the affected joint
- Patient has significant osteoporosis as defined by treating surgeon
- Patient has metabolic disorder(s) which may impair bone formation
- Patient has osteomalacia
- Patient has distant foci of infections which may spread to the implant site
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 |
|---|---|---|
| G7 Dual Mobility with Vivacit-E bearinghip arthroplasty with G7 Dual Mobility Vivacit-E bearing | Device | G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA, G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty |
| G7 Dual Mobility Longevity bearinghip arthroplasty with G7 Dual Mobility Longevity bearing | Device | G7 Dual Mobility with Longevity polyethylene bearing in primary THA, G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty |
Primary outcome
Survival of the implant system
Time frame: 10 years
Survival of the implant system based on removal of the study device
Safety of the implant system
Time frame: 10 years
Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
4 secondary outcomes
Modified Harris Hip Score
Time frame: 10 years
Oxford Hip Score
Time frame: 10 years
EQ-5D-5L
Time frame: 10 years
Radiographic Assessment
Time frame: 5 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 15 Jun 2025.
- 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.
Hassan Achakri study director
Zimmer Biomet
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G7 Dual Mobility with Vivacit-E bearing and G7 Dual Mobility Longevity bearing in people with Hip Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 10 sites in 4 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 11 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, South Korea, Belgium, Italy. 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 implant system (time frame: 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 15 Jun 2025.