MDR Vivacit-E Elevated Study (NCT07150221) | Clinical Trial Compass
By InvitationNot Applicable
MDR Vivacit-E Elevated Study
United States52 participantsStarted 2026-01-07
Plain-language summary
The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
Who can participate
Age range
18 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 was 18 years of age or older and skeletally mature at the time of surgery
* Patient qualified for and underwent surgical procedure with a Vivacit-E Vitamin E HXLPE Elevated Liner to treat one of the following indications in primary THA:
* Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Protrusio acetabuli
* Traumatic arthritis
* Slipped capital epiphysis
* Fused hip
* Fracture of the pelvis
* Diastrophic variant
* Patient underwent surgical procedure 10 years (+ no maximum/- 182 days) prior to date of study consent
* Patient is will and able to sign IRB approved Informed Consent Form or provide verbal consent
Exclusion Criteria:
* Off label use or not according to the approved IFU at the time of surgery
* Patient presented with any of the following at the time of the surgical procedure:
* Osteoradionecrosis
* Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
* Systemic or local infection
* Revision procedure where other treatment or devices have failed\*
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
* Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
* For the purpose of this clinical study; a revision procedure refers to a procedure in which the prior procedure on the ipsilateral hip utilized a si…
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.