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The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified.
The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners | Other | Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivacit-E and Longevity (HXLPE) Liners | Device | This is a dual cohort study in which 150 subjects will receive the Vivacit-E (HXLPE) Liner and 150 subjects will receive the Longevity (HXLPE) Liner. |
| Measure | Description | Time Frame |
|---|---|---|
| Survival of the study device (liner); whether or not it is still implanted in the subject | Survivorship will be based on revision or intended revision of the study device (liner). | At 10 years |
| Adverse Event (safety) | Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects. | At 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Function using Modified Harris Hip Score | Pain and function will be measured using the Modified Harris Hip Score self assessment. The overall score runs from 0-100 with 100 representing the best outcome. | At 10 years |
| Pain and Function using Oxford Hip Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy J Hatcher | Contact | 574-549-4281 | wendy.hatcher@zimmerbiomet.com | |
| Lynsey Boyle | Contact | 412-552-7111 | lynsey.boyle@zimmerbiomet.com |
| Name | Affiliation | Role |
|---|---|---|
| Hillary Overholser | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Joint Replacement | Active, not recruiting | Denver | Colorado | 80210 | United States | |
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Pain and function will be measured using the Oxford Hip Score self assessment. The overall score runs from 0-48 with 48 representing the best outcome. |
| At 10 years |
| Patient Quality of Life using EQ-5D-5L Descriptive System | Perceived qualify of life will be measured using the EQ-5D-5L Descriptive System - comprises mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each question in this section has an overall score of 1-5 with 1 representing the best health. | At 10 years |
| Patient Quality of Life using EQ-5D-5L EQ visual analogue scale | Perceived qualify of life will be measured using the EQ visual analogue scale (EQ VAS) - records the respondent's self-rated health on a vertical, visual analogue scale. This section has an overall score of 0-100 with 100 representing the best health. | At 10 years |
| South Bend Orthopaedics |
| Active, not recruiting |
| South Bend |
| Indiana |
| 46635 |
| United States |
| Duke University Medical Center | Active, not recruiting | Durham | North Carolina | 27703 | United States |
| Slocum Center for Orthopedics & Sports Medicine | Active, not recruiting | Eugene | Oregon | 97401 | United States |
| Oregon Health and Science University | Active, not recruiting | Portland | Oregon | 97239 | United States |
| University of Utah Health | Active, not recruiting | Salt Lake City | Utah | 84112 | United States |
| Copenhagen University Hospital Hvidovre | Recruiting | Hvidovre | 2650 | Denmark |
|
| Zuyderland Hospital | Active, not recruiting | Geleen | 6162 BG | Netherlands |
| OCON Hengelo | Recruiting | Hengelo | Netherlands |
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| Skane University Hospital | Recruiting | Lund | 221 85 | Sweden |
|
| The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital | Recruiting | Bournemouth | UK | BH7 7DW | United Kingdom |
|
| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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