Noninflammatory Degenerative Joint Disease, Rheumatoid Arthritis
Conditions
Keywords
Joint, Osteoarthritis, Avascular Necrosis
Brief 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.
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.
Interventions
DEVICEMetal on Polyethylene articulation
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
DEVICECeramic on Polyethylene articulation
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
DEVICECeramic on Ceramic articulation
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Infection, sepsis and osteomyelitis * Subjects unable to cooperate with and complete the study * Neurological conditions affecting movement * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Hip Score | Pre-op, 1, 2, and 5 years postoperatively | 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. |
| Survivorship | 7 and 10 Year post-operative | Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate. |
| Radiographic Evaluation | Immediate post-op, 3 months, 1, 2, and 5 years | 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. |
Countries
France, Germany, Ireland, Netherlands, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metal on Polyethylene Articulation G7 cup with Metal on Polyethylene articulation (MOP) | 96 |
| Ceramic on Polyethylene Articulation G7 cup with Ceramic on Polyethylene articulation (COP) | 37 |
| Ceramic on Ceramic Articulation G7 cup with Ceramic on Ceramic articulation (COC) | 29 |
| Total | 162 |
Baseline characteristics
| Characteristic | Total | Metal on Polyethylene Articulation | Ceramic on Polyethylene Articulation | Ceramic on Ceramic Articulation |
|---|---|---|---|---|
| Age, Continuous | 66 Years | 68.8 Years | 61 Years | 61 Years |
| Harris Hip Score | 46.1 Scores STANDARD_DEVIATION 15.7 | 45.8 Scores STANDARD_DEVIATION 16.7 | 43.1 Scores STANDARD_DEVIATION 12.6 | 50.7 Scores STANDARD_DEVIATION 15.4 |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — |
| Sex: Female, Male Female | 79 Participants | 46 Participants | 26 Participants | 7 Participants |
| Sex: Female, Male Male | 83 Participants | 50 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 5 / 96 | 1 / 37 | 3 / 29 |
| other Total, other adverse events | 4 / 96 | 0 / 37 | 0 / 29 |
| serious Total, serious adverse events | 19 / 96 | 9 / 37 | 13 / 29 |
Outcome results
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.
Time frame: Pre-operative,1, 2, and 5 years postoperatively
Population: The number of participants decreased around the 5-year visit due to substantial patient loss at certain sites.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metal on Polyethylene articulation | Harris Hip Score | Pre-op | 45.8 Score | Standard Deviation 16.7 |
| Metal on Polyethylene articulation | Harris Hip Score | 1 Year | 95.4 Score | Standard Deviation 7.4 |
| Metal on Polyethylene articulation | Harris Hip Score | 2 Year | 96.1 Score | Standard Deviation 6.4 |
| Metal on Polyethylene articulation | Harris Hip Score | 5 Year | 94.8 Score | Standard Deviation 7.1 |
| Ceramic on Polyethylene articulation | Harris Hip Score | 5 Year | 91.7 Score | Standard Deviation 6.8 |
| Ceramic on Polyethylene articulation | Harris Hip Score | Pre-op | 43.1 Score | Standard Deviation 12.6 |
| Ceramic on Polyethylene articulation | Harris Hip Score | 2 Year | 93.4 Score | Standard Deviation 9.5 |
| Ceramic on Polyethylene articulation | Harris Hip Score | 1 Year | 94.2 Score | Standard Deviation 7.3 |
| Ceramic on Ceramic articulation | Harris Hip Score | 5 Year | 94.1 Score | Standard Deviation 7.8 |
| Ceramic on Ceramic articulation | Harris Hip Score | 1 Year | 92.8 Score | Standard Deviation 10 |
| Ceramic on Ceramic articulation | Harris Hip Score | 2 Year | 94.3 Score | Standard Deviation 8.7 |
| Ceramic on Ceramic articulation | Harris Hip Score | Pre-op | 50.7 Score | Standard Deviation 15.4 |
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.
Time frame: Pre-op, 1, 2, and 5 years postoperatively
Population: The number of participants decreased around the 5-year visit due to substantial patient loss at certain sites.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metal on Polyethylene articulation | Oxford Hip Score | Pre-op | 19.6 Score | Standard Deviation 9.1 |
| Metal on Polyethylene articulation | Oxford Hip Score | 5 Year | 46.5 Score | Standard Deviation 2.4 |
| Metal on Polyethylene articulation | Oxford Hip Score | 1 Year | 46.1 Score | Standard Deviation 3.3 |
| Metal on Polyethylene articulation | Oxford Hip Score | 2 Year | 46.7 Score | Standard Deviation 2.4 |
| Ceramic on Polyethylene articulation | Oxford Hip Score | Pre-op | 16.2 Score | Standard Deviation 6.3 |
| Ceramic on Polyethylene articulation | Oxford Hip Score | 5 Year | 45.8 Score | Standard Deviation 2.4 |
| Ceramic on Polyethylene articulation | Oxford Hip Score | 1 Year | 45.4 Score | Standard Deviation 3.3 |
| Ceramic on Polyethylene articulation | Oxford Hip Score | 2 Year | 45.2 Score | Standard Deviation 5.1 |
| Ceramic on Ceramic articulation | Oxford Hip Score | 5 Year | 43.4 Score | Standard Deviation 7.9 |
| Ceramic on Ceramic articulation | Oxford Hip Score | Pre-op | 22.7 Score | Standard Deviation 9 |
| Ceramic on Ceramic articulation | Oxford Hip Score | 2 Year | 44.4 Score | Standard Deviation 6.1 |
| Ceramic on Ceramic articulation | Oxford Hip Score | 1 Year | 45.4 Score | Standard Deviation 2.9 |
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.
Time frame: Immediate post-op, 3 months, 1, 2, and 5 years
Population: The number of cases decreased around 5 years because two sites discontinued the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Metal on Polyethylene articulation | Radiographic Evaluation | 5 Years | 39.6 Degree | Standard Deviation 4.3 |
| Metal on Polyethylene articulation | Radiographic Evaluation | Immediate Post-Op | 43.2 Degree | Standard Deviation 5.8 |
| Metal on Polyethylene articulation | Radiographic Evaluation | 1 Year | 42.3 Degree | Standard Deviation 5.7 |
| Metal on Polyethylene articulation | Radiographic Evaluation | 3 Months | 42.8 Degree | Standard Deviation 5.4 |
| Metal on Polyethylene articulation | Radiographic Evaluation | 2 Years | 42.7 Degree | Standard Deviation 5.9 |
| Ceramic on Polyethylene articulation | Radiographic Evaluation | 3 Months | 41.8 Degree | Standard Deviation 5.5 |
| Ceramic on Polyethylene articulation | Radiographic Evaluation | 5 Years | 41.8 Degree | Standard Deviation 4 |
| Ceramic on Polyethylene articulation | Radiographic Evaluation | 2 Years | 42.0 Degree | Standard Deviation 5.4 |
| Ceramic on Polyethylene articulation | Radiographic Evaluation | Immediate Post-Op | 41.9 Degree | Standard Deviation 5.7 |
| Ceramic on Polyethylene articulation | Radiographic Evaluation | 1 Year | 42.4 Degree | Standard Deviation 5.1 |
| Ceramic on Ceramic articulation | Radiographic Evaluation | 5 Years | 38.0 Degree | Standard Deviation 6.9 |
| Ceramic on Ceramic articulation | Radiographic Evaluation | Immediate Post-Op | 37.2 Degree | Standard Deviation 6.1 |
| Ceramic on Ceramic articulation | Radiographic Evaluation | 3 Months | 37.2 Degree | Standard Deviation 6.1 |
| Ceramic on Ceramic articulation | Radiographic Evaluation | 2 Years | 37.6 Degree | Standard Deviation 6.1 |
| Ceramic on Ceramic articulation | Radiographic Evaluation | 1 Year | 37.3 Degree | Standard Deviation 6.3 |
Secondary
Survivorship
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
Time frame: 7 and 10 Year post-operative
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Metal on Polyethylene articulation | Survivorship | 10 Year | 0.9762 proportion of participants |
| Metal on Polyethylene articulation | Survivorship | 7 Year | 0.9762 proportion of participants |
| Ceramic on Polyethylene articulation | Survivorship | 10 Year | NA proportion of participants |
| Ceramic on Polyethylene articulation | Survivorship | 7 Year | 0.9697 proportion of participants |
| Ceramic on Ceramic articulation | Survivorship | 7 Year | 1.0000 proportion of participants |
| Ceramic on Ceramic articulation | Survivorship | 10 Year | NA proportion of participants |
Secondary
Survivorship
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
Time frame: 10 Year post-operative
Population: A Kaplan-Meier survival analysis was performed for all cases including 39 from MoP arm, 16 from CoP arm, 13 from CoC arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metal on Polyethylene articulation | Survivorship | 0.9818 proportion of participants |