Clinical OutcomesNCT03308929
Prospective G7 Dual Mobility Total Hip PMCF
An observational study of Clinical Outcomes and Functional Outcomes, run by Zimmer Biomet at 6 sites in United States.
Trial summary
This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clinical Outcomes, Functional Outcomes, Radiological Outcomes
- What is being tested?
- G7 Dual Mobility hip
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Feb 2017to 28 Feb 2029
- Phase
- Observational
- 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
Study population: All patients undergoing revision hip arthroplasty, undergoing a hip arthroplasty to correct a functional deformity, patients seeking treatment for femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques, and patients with significant hip pain or functional limitations and who are at a high dislocation risk will be considered for the study. Patients may have avascular necrosis, osteo- or rheumatoid arthritis.
Who may be able to join
- Patients who are undergoing revision hip arthroplasty
- -OR
- Patients who are undergoing total hip arthroplasty (THA) for the correction of a functional deformity
- OR
- Patients in need of treatment of femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- OR
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- Patients suffer from substantial pain and/or limited function, are appropriate for a primary total hip arthroplasty, considered at high risk for dislocation and have one of the following:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study
- From 18 to 80 years of age (inclusive) at time of procedure
- BMI equal to or less than 35
- Unilateral total hip replacement
- Willing and able to comply with the study procedures
Who cannot join
- Patients undergoing total hip arthroplasty following non-union of previous surgically treated fracture.
- Infection, sepsis or osteomyelitis at the affected joint
- Significant osteoporosis as defined by treating surgeon
- Metabolic disorders which may impair bone formation
- Osteomalacia
- Distant foci of infections which may spread to the implant site
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- Rapid joint destruction, marked bone loss or bone resorption on preoperative radiographs
- Underwent contralateral THA within 12 months of planned index procedure
- Contralateral THA planned within 12 months of index procedure
- Vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease
- The patient is
- A prisoner
- A known alcohol or drug abuser
- The patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant
- The patient is known to be pregnant
- The patient has a known sensitivity or allergy to one or more of the implanted materials, inducing but not limited to chromium, cobalt, and ceramic
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
New Mexico Orthopaedics
Albuquerque, New Mexico, 87106
University of North Carolina
Chapel Hill, North Carolina, 27599
Tidewater Orthopaedics
Hampton, Virginia, 23666
Jersey City Medical Center
Jersey City, New Jersey, 07302
Oregon Health and Science University
Portland, Oregon, 97239
Ortho Virginia
Richmond, Virginia, 23235
About this study
Official title: Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System
This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.
Read the detailed description
This multi-center prospective follow-up study will evaluate clinical outcomes, functional outcomes, radiological outcomes and further characterize the safety profile of the G7 Dual Mobility Hip Arthroplasty System. This will be accomplished by assessing these domains using the Harris Hip Score, UCLA Activity Score, and EQ-5D-3L, obtaining and assessing radiographs and the tracking of device or procedure related adverse events. Subjects will undergo unilateral primary or revision total hip arthroplasty and will then be followed for 10 years with intervals at 6 weeks, 1-, 2-, 3- 5- and 10 years. For the 10 year visit, subjects will not be required to present in their doctor's office, but will fill out a survey. Subsequent to 10 year data collection, the subject's participation in the study will be compete.
- Being tested
- G7 Dual Mobility hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G7 Dual Mobility hipDevice
Total hip arthroplasty and implantation of the G7 device
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship of the study device
This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.
Measured: 5 years
Secondary outcomes (5)
Radiographic measurements of the implanted device
Standard AP radiographs of implanted hip will assess the positioning of the device as well as lucencies and other potential anomalies.
Measured: 10 years
Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device
Assessed by tracking the type of adverse event, severity and relation of the event(s) to the study device
Measured: 10 years
Patient Physical Activity
UCLA activity score - patient self assessment
Measured: 10 years
Patient Quality of Life
EQ-3L-5D quality of life measure - patient self assessment
Measured: 10 years
Harris Hip Score
Harris Hip score measures pain, function, absence of deformity, and range of motion. Scores range from 0-100 with higher scores representing less dysfunction and better outcomes
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start28 Feb 2017
- Primary completion1 Jul 2027 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical OutcomesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hillary Overholser, MS, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308929
- Sponsor's protocol ID
- H.CR.I.G.16.5
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2017
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-Center Clinical Evaluation Following Total Hip Arthroplasty With the G7 Dual Mobility System
- ClinicalTrials.gov ID
- NCT03308929
- Acronym / sponsor ID
- H.CR.I.G.16.5
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 13 Oct 2017 (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 is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.
Detailed description
This multi-center prospective follow-up study will evaluate clinical outcomes, functional outcomes, radiological outcomes and further characterize the safety profile of the G7 Dual Mobility Hip Arthroplasty System. This will be accomplished by assessing these domains using the Harris Hip Score, UCLA Activity Score, and EQ-5D-3L, obtaining and assessing radiographs and the tracking of device or procedure related adverse events. Subjects will undergo unilateral primary or revision total hip arthroplasty and will then be followed for 10 years with intervals at 6 weeks, 1-, 2-, 3- 5- and 10 years. For the 10 year visit, subjects will not be required to present in their doctor's office, but will fill out a survey. Subsequent to 10 year data collection, the subject's participation in the study will be compete.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing revision hip arthroplasty, undergoing a hip arthroplasty to correct a functional deformity, patients seeking treatment for femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques, and patients with significant hip pain or functional limitations and who are at a high dislocation risk will be considered for the study. Patients may have avascular necrosis, osteo- or rheumatoid arthritis.
Key inclusion criteria (14 listed)
- Patients who are undergoing revision hip arthroplasty
- -OR
- Patients who are undergoing total hip arthroplasty (THA) for the correction of a functional deformity
- Patients in need of treatment of femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
- Patients suffer from substantial pain and/or limited function, are appropriate for a primary total hip arthroplasty, considered at high risk for dislocation and have one of the following:
Key exclusion criteria (16 listed)
- Patients undergoing total hip arthroplasty following non-union of previous surgically treated fracture.
- Infection, sepsis or osteomyelitis at the affected joint
- Significant osteoporosis as defined by treating surgeon
- Metabolic disorders which may impair bone formation
- Osteomalacia
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 hipTotal hip arthroplasty and implantation of the G7 device | Device | – |
Primary outcome
Survivorship of the study device
Time frame: 5 years
This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.
5 secondary outcomes
Radiographic measurements of the implanted device
Time frame: 10 years
Frequency and incidence of adverse events for all subjects with particular focus on those related or potentially related to the device
Time frame: 10 years
Patient Physical Activity
Time frame: 10 years
Patient Quality of Life
Time frame: 10 years
Harris Hip Score
Time frame: 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 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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, MS study director
Zimmer Biomet
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Outcomes and Functional Outcomes, run by Zimmer Biomet at 6 sites in United States.
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 14 inclusion and 16 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Survivorship of the study device (time frame: 5 years). 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 5 Oct 2026.