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.
Patient must be a legal adult who has reached full skeletal maturity.
Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.
Patient has a metabolic disorder that may impair bone formation.
Patient has osteomalacia.
Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.
Single group
Vivacit-E and Longevity (HXLPE) Liners
DeviceThis 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.
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).
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.
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.
Pain and Function using Oxford Hip Score
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.
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.
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.
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