G7 Dual Mobility With Vivacit-E or Longevity PMCF (NCT05548972) | Clinical Trial Compass
By InvitationNot Applicable
G7 Dual Mobility With Vivacit-E or Longevity PMCF
United States, Belgium, Italy358 participantsStarted 2023-03-20
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.