G7 Dual Mobility With Vivacit-E or Longevity PMCF

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Global, Multicenter and Prospective Post-Market Clinical Follow-Up Study of the G7® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation

Conditions
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Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis, Dislocation, Hip, Femoral Neck Fractures, Trochanteric Fractures, Revision Surgeries

Intervention / Treatment
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* Device: G7 Dual Mobility with Vivacit-E bearing
* Device: G7 Dual Mobility Longevity bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 to 80 years of age, inclusive Patient is skeletally mature Patient qualifies for (total) hip arthroplasty based on physical exam and medical history including at least one of the following: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Dislocation risks Correction of functional deformity Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Revision procedures where other treatment or devices have failed. Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent Exclusion Criteria: Patient is septic, has an active infection or has osteomyelitis at the affected joint Patient has significant osteoporosis as defined by treating surgeon Patient has metabolic disorder(s) which may impair bone formation Patient has osteomalacia Patient has distant foci of infections which may spread to the implant site Patient has rapid joint destruction, marked bone loss or bone resorption apparent on pre-operative radiographs Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure Patient is undergoing simultaneous bilateral THA Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which are likely to jeopardize the outcome of the surgery. Patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant Patient is known to be pregnant The patient is in a vulnerable population group such as: a prisoner a known alcohol or drug abuser mentally incompetent or unable to understand what participation in this study entails

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA<br>Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60) | Device: G7 Dual Mobility with Vivacit-E bearing<br>* hip arthroplasty with G7 Dual Mobility Vivacit-E bearing<br>|
| Other: G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty<br>Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119) | Device: G7 Dual Mobility with Vivacit-E bearing<br>* hip arthroplasty with G7 Dual Mobility Vivacit-E bearing<br>|
| Other: G7 Dual Mobility with Longevity polyethylene bearing in primary THA<br>Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60) | Device: G7 Dual Mobility Longevity bearing<br>* hip arthroplasty with G7 Dual Mobility Longevity bearing<br>|
| Other: G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty<br>Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119) | Device: G7 Dual Mobility Longevity bearing<br>* hip arthroplasty with G7 Dual Mobility Longevity bearing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of the implant system | Survival of the implant system based on removal of the study device | 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. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip arthroplasty, Revision Hip arthroplasty, Medical device, Safety, Performance, Clinical benefit, G7 Dual Mobility