This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty
The G7 Dual Mobility construct offers dislocation resistance without the need to constrain the femoral head, providing stability and high range of motion. Dual Mobility systems decrease the risk of post-operative instability in high-risk patients in both primary and revision arthroplasties. This study will enroll up to 358 hips globally, 179 for the Vivacit-E and 179 for the Longevity polyethylene bearings. From the 179 hips per bearing variant, the study will enroll 60 primary and 119 revision arthroplasty hips. The Longevity bearing variant will only be enrolled in the US, as it is not CE marked and unregistered in the APAC market. Vivacit-E bearings will be enrolled globally. A maximum of 20 study centers will be selected globally. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target maximum 24 primary hip arthroplasties and maximum 47 revision hip arthroplasties. Each site is encouraged to enroll both, primary and revision, subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
358
hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
hip arthroplasty with G7 Dual Mobility Longevity bearing
Bowen Hefley Orthopedics
Little Rock, Arkansas, United States
HCA HealthONE Orthopedic Specialists
Denver, Colorado, United States
Jersey City Medical Center
Jersey City, New Jersey, United States
Hospital for Special Surgery
New York, New York, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Slocum Research & Education Foundation
Eugene, Oregon, United States
UZ Leuven
Leuven, Belgium
Istituto San Siro
Milan, Italy
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam, South Korea
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Survival of the implant system
Survival of the implant system based on removal of the study device
Time frame: 10 years
Safety of the implant system
Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
Time frame: 10 years
Modified Harris Hip Score
The modified Harris Hip Score measures pain, function and functional activities using a self assessment. The overall score runs from 0-100 with 100 representing the best outcome.
Time frame: 10 years
Oxford Hip Score
The Oxford Hip Score measures pain and function using a self assessment. The overall score runs from 0-48 with 48 representing the best outcome.
Time frame: 10 years
EQ-5D-5L
The EQ-5D-5L measures the quality of life using a self assessment. The questionnaire includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time frame: 10 years
Radiographic Assessment
X-ray evaluation to find significant radiographic findings such as radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc
Time frame: 5 years
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