Enrolling by invitation
Not applicable
G7 Dual Mobility With Vivacit-E or Longevity PMCF
Condition(s) studied
Hip OsteoarthritisRheumatoid ArthritisJoint DiseasesAvascular NecrosisDislocation, HipFemoral Neck FracturesTrochanteric FracturesRevision Surgeries
Investigational drug(s) / intervention(s)
G7 Dual Mobility with Vivacit-E bearingG7 Dual Mobility Longevity bearing
G7 Dual Mobility with Vivacit-E bearing: hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
G7 Dual Mobility Longevity bearing: hip arthroplasty with G7 Dual Mobility Longevity bearing
Study 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
Eligibility
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
Primary outcome measure(s)
- Survival of the implant system — 10 years
Survival of the implant system based on removal of the study device
- Safety of the implant system — 10 years
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.
Trial sites (10)
| Facility | City | Region | Status |
| Bowen Hefley Orthopedics |
Little Rock |
Arkansas |
|
| HCA HealthONE Orthopedic Specialists |
Denver |
Colorado |
|
| Jersey City Medical Center |
Jersey City |
New Jersey |
|
| Hospital for Special Surgery |
New York |
New York |
|
| The Cleveland Clinic |
Cleveland |
Ohio |
|
| Slocum Research & Education Foundation |
Eugene |
Oregon |
|
| UZ Leuven |
Leuven |
Belgium |
|
| Istituto San Siro |
Milan |
Italy |
|
| Pusan National University Yangsan Hospital |
Yangsan |
Gyeongsangnam |
|
| Chonnam National University Hwasun Hospital |
Hwasun |
Jeollanam-do |
|
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