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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.
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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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300 participants in 1 patient group
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Wendy J Hatcher; Lynsey Boyle
Data sourced from clinicaltrials.gov
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