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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metal on Polyethylene articulation | G7 cup with Metal on Polyethylene articulation (MOP) |
| |
| Ceramic on Polyethylene articulation | G7 cup with Ceramic on Polyethylene articulation (COP) |
| |
| Ceramic on Ceramic articulation | G7 cup with Ceramic on Ceramic articulation (COC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metal on Polyethylene articulation | Device | G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP) |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-operative,1, 2, and 5 years postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinic
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Rohmer | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Orthopedic Specialists | Tucson | Arizona | 85718 | United States | ||
| Clermont-Ferrand Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metal on Polyethylene Articulation | G7 cup with Metal on Polyethylene articulation (MOP) |
| FG001 | Ceramic on Polyethylene Articulation | G7 cup with Ceramic on Polyethylene articulation (COP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 26, 2013 | Nov 11, 2025 |
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| Ceramic on Polyethylene articulation | Device | G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP) |
|
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| Ceramic on Ceramic articulation | Device | G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY |
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| 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. | 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. | 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. | Immediate post-op, 3 months, 1, 2, and 5 years |
| Clermont-Ferrand |
| France |
| University of Würzburg, Orthopedic | Würzburg | Germany |
| Midwestern Regional Orthopaedic Hospital | Limerick | Ireland |
| Reinier de Graaf Groep | Delft | Netherlands |
| Hospital El Bierzo | Ponferrada | Spain |
| FG002 | Ceramic on Ceramic Articulation | G7 cup with Ceramic on Ceramic articulation (COC) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Metal on Polyethylene Articulation | G7 cup with Metal on Polyethylene articulation (MOP) |
| BG001 | Ceramic on Polyethylene Articulation | G7 cup with Ceramic on Polyethylene articulation (COP) |
| BG002 | Ceramic on Ceramic Articulation | G7 cup with Ceramic on Ceramic articulation (COC) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | Years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Harris Hip Score | Scores at preop visit are available for fewer patients than total enrollment due to retrospective data collection. | Mean | Standard Deviation | Scores |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The number of participants decreased around the 5-year visit due to substantial patient loss at certain sites. | Posted | Mean | Standard Deviation | Score | Pre-operative,1, 2, and 5 years postoperatively |
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| Secondary | 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. | The number of participants decreased around the 5-year visit due to substantial patient loss at certain sites. | Posted | Mean | Standard Deviation | Score | Pre-op, 1, 2, and 5 years postoperatively |
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| Secondary | Survivorship | Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate. | The K-M survival for CoP and CoC groups were only calculated up to 7 years because less than 20 cases remained at risk after that timepoint, which was below the level of detection to calculate a reliable Kaplan Meier estimate. | Posted | Number | 95% Confidence Interval | proportion of participants | 7 and 10 Year post-operative |
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| Secondary | Survivorship | Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate. | A Kaplan-Meier survival analysis was performed for all cases including 39 from MoP arm, 16 from CoP arm, 13 from CoC arm. | Posted | Number | 95% Confidence Interval | proportion of participants | 10 Year post-operative |
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| Secondary | 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. | The number of cases decreased around 5 years because two sites discontinued the study. | Posted | Mean | Standard Deviation | Degree | Immediate post-op, 3 months, 1, 2, and 5 years |
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Adverse events that met the criteria for serious adverse events (SAE), adverse device effects (ADE), serious adverse device effect (SADE), and unexpected serious adverse device effect (USADE) have been included throughout the participation of the study from date of surgery to 10-year follow-up.
Adverse Events and Adverse Device Effects were documented during the whole course of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metal on Polyethylene Articulation | G7 cup with Metal on Polyethylene articulation (MOP) | 5 | 96 | 19 | 96 | 4 | 96 |
| EG001 | Ceramic on Polyethylene Articulation | G7 cup with Ceramic on Polyethylene articulation (COP) | 1 | 37 | 9 | 37 | 0 | 37 |
| EG002 | Ceramic on Ceramic Articulation | G7 cup with Ceramic on Ceramic articulation (COC) | 3 | 29 | 13 | 29 | 0 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision | Musculoskeletal and connective tissue disorders | Systematic Assessment | ADE, Revision of Investigational Device |
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| Dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Death (unknown cause) | General disorders | Systematic Assessment | Death from unknown cause - not reported in patient medical record |
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| Infection | Infections and infestations | Systematic Assessment |
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| Liner wear | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Deep vein thrombosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Musculoskeletal / Soft tissue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| General AE | General disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Device Effects (ADE): Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oliver Marti | Zimmer Biomet | +41 79 576 31 98 | oliver.marti1@zimmerbiomet.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 Year |
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| 2 Year |
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| 5 Year |
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| Units | Counts |
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| Title | Denominators | Categories | ||||
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