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 range18 Years
SexALL
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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…