Rheumatoid ArthritisNCT03266874
G7 BiSpherical Acetabular Shell PMCF Study
An observational study of Rheumatoid Arthritis and Osteoarthritis, run by Zimmer Biomet at 5 sites in 4 countries.
Trial summary
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Osteoarthritis, Noninflammatory Degenerative Joint Disease
- How many people
- 160 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 10 Dec 2017to Dec 2031
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients in need of a Total Hip Arthroplasty (primary or revision) which receive the G7 BiSperical Acetabular Shell and who meet all of the inclusion and none of the exclusion criteria.
Who may be able to join
- Patient capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
- Patient aged of 18 years or more whose skeleton reached bone maturity.
- 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.
- Inclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7 Freedom Constrained Liner:
- The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to con-strained acetabular components have been considered.
Who cannot join
- Absolute exclusion criteria include:
- Infection, sepsis, osteomyelitis.
- Relative exclusion criteria include:
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions.
- Osteoporosis.
- Metabolic disorders which may impair bone formation.
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- Osteomalacia.
- Distant foci of infections which may spread to the implant site.
- Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
- Vascular insufficiency, muscular atrophy or neuromuscular disease.
- Patient unwilling or unable to give consent, or to comply with the follow-up program.
- Patient known to be pregnant or breastfeeding.
- Patient presenting any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study.
- Patient institutionalized or known drug abuser or alcoholic or anyone who cannot understand what is required of them.
- Patient belonging to a vulnerable population.
- Exclusion criteria specific for patients receiving the G7 BiSpherical Shell with the G7 Freedom Constrained Liner:
- Bone or musculature compromised by disease, infection, or prior implantation that cannot provide adequate support or fixation for the prosthesis.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Herzogin Elisabeth Hospital
Braunschweig, Lower Saxony, 38124
Orthopädische Chirurgie Müchen OCM
Munich, Bavaria, 81369
About this study
Official title: Prospective Multicenter Observational Evaluation of the Use of the G7 BiSpherical Acetabular Shell
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.
Read the detailed description
The G7 BiSpherical Acetabular Shell belongs to the G7 multi-bearing platform. It was developed to provide an additional surgical option for patients in need of a total hip replacement. The aim of the G7 BiSpherical Acetabular Shell is to increase hip function while reducing pain.
This study is a multicenter, prospective, non-randomized, non-controlled post market surveillance study involving orthopedic surgeons skilled in hip arthroplasty procedures. A minimum of 4 and a maximum of 5 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators. 140-175 implants will be included into the study. Each site will be allowed to enroll 35 patients. All potential study subjects will be required to participate in the Informed Consent Process.
The safety and performance of the G7 BiSpherical Acetabular Shell will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical efficacy measured by overall pain and function, quality of life data and radiographic evaluation.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity, Non-Union Fracture
- Keywords
- total hip arthroplasty
- Medical subject headings
- Arthritis, Rheumatoid, Osteoarthritis, Osteonecrosis, Fractures, Ununited, Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received the G7 BiSpherical Cup | Subject in need of a THA who met the inclusion/exclusion criteria and received the G7 BiSpherical cup. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survivorship is assessed counting the number of implant revisions
Measured: 10 years
Secondary outcomes (3)
Clinical efficacy of the device is assessed using the Oxford Hip Score patient questionnaire
Measured: 10 years
Clinical efficacy of the device is assessed using the Harris Hip Score patient questionnaire
Measured: 10 years
Safety is assessed according to the number of complications which are collected via adverse event forms.
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 posted30 Aug 2017
- Study start10 Dec 2017
- Primary completionDec 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 160 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
- NCT03266874
- Sponsor's protocol ID
- H.CR.I.EU.16.26
- Status last verified
- Jun 2025
- First submitted
- 24 Aug 2017
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Evaluation of the Use of the G7 BiSpherical Acetabular Shell
- ClinicalTrials.gov ID
- NCT03266874
- Acronym / sponsor ID
- H.CR.I.EU.16.26
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity, Non-Union Fracture
- Keywords
- total hip arthroplasty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 30 Aug 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.
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.
Detailed description
The G7 BiSpherical Acetabular Shell belongs to the G7 multi-bearing platform. It was developed to provide an additional surgical option for patients in need of a total hip replacement. The aim of the G7 BiSpherical Acetabular Shell is to increase hip function while reducing pain.
This study is a multicenter, prospective, non-randomized, non-controlled post market surveillance study involving orthopedic surgeons skilled in hip arthroplasty procedures. A minimum of 4 and a maximum of 5 sites will be involved in this study. This number of clinical centers will permit assessment of consistency among a multitude of investigators. 140-175 implants will be included into the study. Each site will be allowed to enroll 35 patients. All potential study subjects will be required to participate in the Informed Consent Process.
The safety and performance of the G7 BiSpherical Acetabular Shell will be assessed as following: implant survivorship based on revision with removal of the study device; safety based on incidence and frequency of adverse events; and clinical efficacy measured by overall pain and function, quality of life data and radiographic evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received the G7 BiSpherical Cup | – | –Subject in need of a THA who met the inclusion/exclusion criteria and received the G7 BiSpherical cup. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients in need of a Total Hip Arthroplasty (primary or revision) which receive the G7 BiSperical Acetabular Shell and who meet all of the inclusion and none of the exclusion criteria.
Key inclusion criteria (9 listed)
- Patient capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program and who gave consent to take part in the study.
- Patient aged of 18 years or more whose skeleton reached bone maturity.
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Correction of functional deformity.
Key exclusion criteria (17 listed)
- Infection, sepsis, osteomyelitis.
- Uncooperative patient or patient with neurologic disorders who is incapable of following directions.
- Osteoporosis.
- 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.
Primary outcome
Implant survivorship is assessed counting the number of implant revisions
Time frame: 10 years
3 secondary outcomes
Clinical efficacy of the device is assessed using the Oxford Hip Score patient questionnaire
Time frame: 10 years
Clinical efficacy of the device is assessed using the Harris Hip Score patient questionnaire
Time frame: 10 years
Safety is assessed according to the number of complications which are collected via adverse event forms.
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 25 Jun 2025.
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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.
Hassan Achakri study director
Zimmer Biomet
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Osteoarthritis, run by Zimmer Biomet at 5 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 9 inclusion and 17 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 25 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 5 sites in Germany, France, Netherlands, Switzerland. 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?
Implant survivorship is assessed counting the number of implant revisions (time frame: 10 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 25 Jun 2025.