Noninflammatory Degenerative Joint DiseaseNCT02036931
A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
An observational study of Noninflammatory Degenerative Joint Disease and Rheumatoid Arthritis, run by Zimmer Biomet at 6 sites in 6 countries.
Trial summary
This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninflammatory Degenerative Joint Disease, Rheumatoid Arthritis
- What is being tested?
- Metal on Polyethylene articulation, Ceramic on Polyethylene articulation and Ceramic on Ceramic articulation
- Type of treatment
- Medical device
- How many people
- 162 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Mar 2013to May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
- 18 years of age or older
- Subjects willing to return for follow-up evaluations
Who cannot join
- Infection, sepsis and osteomyelitis
- Subjects unable to cooperate with and complete the study
- Neurological conditions affecting movement
- Pregnancy
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United States1 site
University Orthopedic Specialists
Tucson, Arizona, 85718
About this study
This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.
Read the detailed description
This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.
Preoperative and intraoperative data have been collected retrospectively and follow ups have been collected prospectively.
Clinical outcomes included the Harris Hip Score, Oxford Hip Score, and Radiographic Evaluations collected at 3 month, 1, 2 and 5 year follow-up time points. For the 7 and 10 year follow-up intervals, survivorship and adverse events have been collected.
- Being tested
- Metal on Polyethylene articulation, Ceramic on Polyethylene articulation, Ceramic on Ceramic articulation
- Keywords
- Joint, Osteoarthritis, Avascular Necrosis
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal on Polyethylene articulationDevice
Also called MOP
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
Ceramic on Polyethylene articulationDevice
Also called COP
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
Ceramic on Ceramic articulationDevice
Also called COC
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY
| Study group | Role | What they receive |
|---|---|---|
| Metal on Polyethylene articulation | G7 cup with Metal on Polyethylene articulation (MOP) Receives: Device: Metal on Polyethylene articulation | |
| Ceramic on Polyethylene articulation | G7 cup with Ceramic on Polyethylene articulation (COP) Receives: Device: Ceramic on Polyethylene articulation | |
| Ceramic on Ceramic articulation | G7 cup with Ceramic on Ceramic articulation (COC) Receives: Device: Ceramic on Ceramic articulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
The Harris Hip Scale (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, o-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent:90 - 100; Good: 80 - 90; Fair: 70 - 80; Poor: < 70.
Measured: Pre-operative,1, 2, and 5 years postoperatively
Secondary outcomes (4)
Oxford Hip Score
The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27.
Measured: Pre-op, 1, 2, and 5 years postoperatively
Survivorship
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
Measured: 7 and 10 Year post-operative
Survivorship
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
Measured: 10 Year post-operative
Radiographic Evaluation
All radiographs have been reviewed by the investigators at each site in order to detect and report any abnormal and significant findings (including adverse events). The change from the angle of inclination between the different follow-ups is shown in the table.
Measured: Immediate post-op, 3 months, 1, 2, and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2024
- Study completionMay 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Noninflammatory Degenerative Joint DiseaseStudies 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
- Other
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036931
- Sponsor's protocol ID
- ORTHO.CR.GH20
- Status last verified
- Dec 2025
- First submitted
- 14 Jan 2014
- Last updated
- 19 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
- ClinicalTrials.gov ID
- NCT02036931
- Acronym / sponsor ID
- ORTHO.CR.GH20
- Keywords
- Joint, Osteoarthritis, Avascular Necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2024 (actual)
- Study completion
- May 2025 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Posted 19 Dec 2025
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 observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.
Detailed description
This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.
Preoperative and intraoperative data have been collected retrospectively and follow ups have been collected prospectively.
Clinical outcomes included the Harris Hip Score, Oxford Hip Score, and Radiographic Evaluations collected at 3 month, 1, 2 and 5 year follow-up time points. For the 7 and 10 year follow-up intervals, survivorship and adverse events have been collected.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metal on Polyethylene articulation | – | Device: Metal on Polyethylene articulationG7 cup with Metal on Polyethylene articulation (MOP) |
| Ceramic on Polyethylene articulation | – | Device: Ceramic on Polyethylene articulationG7 cup with Ceramic on Polyethylene articulation (COP) |
| Ceramic on Ceramic articulation | – | Device: Ceramic on Ceramic articulationG7 cup with Ceramic on Ceramic articulation (COC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Infection, sepsis and osteomyelitis
- Subjects unable to cooperate with and complete the study
- Neurological conditions affecting movement
- Pregnancy
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 |
|---|---|---|
| Metal on Polyethylene articulationAlso: MOPG7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP) | Device | Metal on Polyethylene articulation |
| Ceramic on Polyethylene articulationAlso: COPG7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP) | Device | Ceramic on Polyethylene articulation |
| Ceramic on Ceramic articulationAlso: COCG7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY | Device | Ceramic on Ceramic articulation |
Primary outcome
Harris Hip Score
Time frame: Pre-operative,1, 2, and 5 years postoperatively
The Harris Hip Scale (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, o-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent:90 - 100; Good: 80 - 90; Fair: 70 - 80; Poor: < 70.
4 secondary outcomes
Oxford Hip Score
Time frame: Pre-op, 1, 2, and 5 years postoperatively
Survivorship
Time frame: 7 and 10 Year post-operative
Survivorship
Time frame: 10 Year post-operative
Radiographic Evaluation
Time frame: Immediate post-op, 3 months, 1, 2, and 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Emilie Rohmer study director
Zimmer Biomet
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noninflammatory Degenerative Joint Disease and Rheumatoid Arthritis, run by Zimmer Biomet at 6 sites in 6 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 19 Dec 2025. 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, France, Germany, Ireland, Netherlands and 1 more country. 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?
Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Harris Hip Score (time frame: Pre-operative,1, 2, and 5 years postoperatively). 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 19 Dec 2025.