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NCT07150221

MDR Vivacit-E Elevated Study

Enrolling by Invitation
Not specifiedAges 18+Observational
Zimmer 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

Osteoarthritis (OA) of the Hip
Avascular Necrosis of Bone of Hip
Protrusio Acetabuli
Traumatic Arthropathy-Hip
Slipped Capital Femoral Epiphyses
Fused Hip
Fracture of Pelvis
Diastrophic Variant

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Acetabular ProtrusionDiastrophic VariantFracture of PelvisFused HipHip OsteoarthritisOsteonecrosis of hipSlipped Capital Femoral EpiphysisTraumatic arthropathy-hip

NCT07150221

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • South Bend Orthopaedics

    South Bend, Indianano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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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.