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Enrolling by invitation Observational

MDR Vivacit-E Elevated Study

NCT07150221 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2026-01-07
Last updated
2026-04-01

Condition(s) studied

Osteoarthritis (OA) of the HipAvascular Necrosis of Bone of HipProtrusio AcetabuliTraumatic Arthropathy-HipSlipped Capital Femoral EpiphysesFused HipFracture of PelvisDiastrophic Variant

Investigational drug(s) / intervention(s)

Vivacit-E Elevated Liners

Vivacit-E Elevated Liners: Primary total hip arthroplasty

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 similar approach (i.e., primary total hip arthoplasty)

Primary outcome measure(s)

  • Survival of the Implant System via Adverse Events — 10 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.

Trial sites (1)

FacilityCityRegionStatus
South Bend Orthopaedics South Bend Indiana

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07150221 on ClinicalTrials.gov ↗ ← All trials in the USA