G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Vivacit-E and Longevity (HXLPE) Liners: 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Survival of the study device (liner); whether or not it is still implanted in the subject — At 10 years
Survivorship will be based on revision or intended revision of the study device (liner). - Adverse Event (safety) — At 10 years
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| Colorado Joint Replacement | Denver | Colorado | |
| South Bend Orthopaedics | South Bend | Indiana | |
| Duke University Medical Center | Durham | North Carolina | |
| Slocum Center for Orthopedics & Sports Medicine | Eugene | Oregon | |
| Oregon Health and Science University | Portland | Oregon | |
| University of Utah Health | Salt Lake City | Utah | |
| Copenhagen University Hospital Hvidovre | Hvidovre | Denmark | |
| Zuyderland Hospital | Geleen | Netherlands | |
| OCON Hengelo | Hengelo | Netherlands | |
| Skane University Hospital | Lund | Sweden | |
| The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital | Bournemouth | UK |
More Zimmer Biomet trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04754087 on ClinicalTrials.gov ↗ ← All trials in the UK