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Manufacturer decided not to proceed with study.
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The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
The objective of this consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the G7 Freedom Constrained Liners when used for primary and revision total hip arthroplasty (implants and instrumentation) at 5 years follow-up. Since G7 Acetabular Cup System has only been on the market since 2015, a prospective follow-up will be necessary to obtain data for the 5 year post-surgery time-point for each patient.
The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified.
The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G7 Freedom Constrained Liners | Patients that have been implanted with a G7 Freedom Constrained liner to repair hip malfunction or disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G7 Freedom Constrained Liners | Device | Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device Safety assessed through the frequency and incidence of revisions, complications and adverse events | The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified. | Out to five years |
| Measure | Description | Time Frame |
|---|---|---|
| Device Performance and Benefits evaluated through the Oxford Hip Score | The OHS is a patient completed 12 question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms. | Out to five years |
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Inclusion Criteria:
Exclusion Criteria:
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This will include a consecutive series of subjects implanted with the G7 Freedom Constrained Liners in primary and revision total hip arthroplasty according to the approved
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| Name | Affiliation | Role |
|---|---|---|
| Erin Osborn | Zimmer Biomet | Study Director |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006620 | Hip Fractures |
| D025981 | Hip Injuries |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| D012216 |
| Rheumatic Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |