Back to resultsG7 Dual Mobility With Vivacit-E or Longevity PMCF
Primary Purpose
Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases
Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
G7 Dual Mobility with Vivacit-E bearing
G7 Dual Mobility Longevity bearing
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring Total Hip arthroplasty, Revision Hip arthroplasty, Medical device, Safety, Performance, Clinical benefit, G7 Dual Mobility
Eligibility Criteria
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
Sites / Locations
- Slocum Research & Education Foundation
- Istituto San Siro
- Pusan National University Yangsan Hospital
- Chonnam National University Hwasun Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA
G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty
G7 Dual Mobility with Longevity polyethylene bearing in primary THA
G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty
Arm Description
Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60)
Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)
Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60)
Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)
Outcomes
Primary Outcome Measures
Survival of the implant system
Survival of the implant system based on removal of the study device
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.
Secondary Outcome Measures
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.
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.
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.
Radiographic Assessment
X-ray evaluation to find significant radiographic findings such as radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05548972
Brief Title
G7 Dual Mobility With Vivacit-E or Longevity PMCF
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
January 2037 (Anticipated)
Study Completion Date
August 2037 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Rheumatoid Arthritis, Joint Diseases, Avascular Necrosis, Dislocation, Hip, Femoral Neck Fractures, Trochanteric Fractures, Revision Surgeries
Keywords
Total Hip arthroplasty, Revision Hip arthroplasty, Medical device, Safety, Performance, Clinical benefit, G7 Dual Mobility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
358 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA
Arm Type
Other
Arm Description
Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60)
Arm Title
G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty
Arm Type
Other
Arm Description
Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)
Arm Title
G7 Dual Mobility with Longevity polyethylene bearing in primary THA
Arm Type
Other
Arm Description
Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60)
Arm Title
G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty
Arm Type
Other
Arm Description
Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)
Intervention Type
Device
Intervention Name(s)
G7 Dual Mobility with Vivacit-E bearing
Intervention Description
hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
Intervention Type
Device
Intervention Name(s)
G7 Dual Mobility Longevity bearing
Intervention Description
hip arthroplasty with G7 Dual Mobility Longevity bearing
Primary Outcome Measure Information:
Title
Survival of the implant system
Description
Survival of the implant system based on removal of the study device
Time Frame
10 years
Title
Safety of the implant system
Description
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
Secondary Outcome Measure Information:
Title
Modified Harris Hip Score
Description
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
Title
Oxford Hip Score
Description
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
Title
EQ-5D-5L
Description
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
Title
Radiographic Assessment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Achakri
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Slocum Research & Education Foundation
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Istituto San Siro
City
Milano
Country
Italy
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongsangnam
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
ZIP/Postal Code
58128
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
G7 Dual Mobility With Vivacit-E or Longevity PMCF
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