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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
Colorado Joint Replacement
Denver, Colorado, United States
ACTIVE_NOT_RECRUITINGSouth Bend Orthopaedics
South Bend, Indiana, United States
ACTIVE_NOT_RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
ACTIVE_NOT_RECRUITINGSlocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, United States
ACTIVE_NOT_RECRUITINGOregon Health and Science University
Portland, Oregon, United States
ACTIVE_NOT_RECRUITINGUniversity of Utah Health
Salt Lake City, Utah, United States
ACTIVE_NOT_RECRUITINGCopenhagen University Hospital Hvidovre
Hvidovre, Denmark
RECRUITINGZuyderland Hospital
Geleen, Netherlands
ACTIVE_NOT_RECRUITINGOCON Hengelo
Hengelo, Netherlands
RECRUITINGSkane University Hospital
Lund, Sweden
RECRUITING...and 1 more locations
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).
Time frame: 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.
Time frame: At 10 years
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.
Time frame: At 10 years
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.
Time frame: 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.
Time frame: 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.
Time frame: At 10 years
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