NCT07150221
MDR Vivacit-E Elevated Study
Enrolling by Invitation
Not specifiedAges 18+ObservationalZimmer Biomet
~52 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Vivacit-E Elevated Liners
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival of the Implant System via Adverse Events
Measured over 10 years
Conditions
Where it's being run
1 sites across 1 statesIndiana1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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 similar approach (i.e., primary total hip arthoplasty)
What this trial measures
- Survival of the Implant System via Adverse Events10 years
The primary endpoint is defined by the survival of the implant system at 10 years post-operative, which is based on removal of the study device and will be determined using the Kaplan Meier method. The safety of the study device will be assessed by monitoring the frequency and incidence of adverse events.