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Long-term follow-up of Vivacit-E hip socket liners in hip replacement

Follows people who had hip replacement using Vivacit-E Elevated Liners.

Key facts

Who runs it
Zimmer Biomet
Where
South Bend, United StatesSee the site
Trial code
Registry title
MDR Vivacit-E Elevated Study
Status
Enrolling by invitation
People taking part
52 people, planned
Started
7 Jan 2026
Expected to end
Dec 2027
Type of study
Observational
Treatments tested
  • Vivacit-E Elevated Liners
Record updated
1 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a first total hip replacement with a Vivacit-E Vitamin E HXLPE Elevated Liner about 10 years ago. It follows how the implant works over the long term.

Age
18 years or older, with a fully grown skeleton at the time of surgery.
Sex
All sexes can join.
Disease stage
People who had a first (primary) hip replacement for one of these: noninflammatory joint wear (osteoarthritis, avascular necrosis), protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, or diastrophic variant.
Earlier treatment
Must have had hip surgery with a Vivacit-E Vitamin E HXLPE Elevated Liner 10 years (+ no maximum/- 182 days) before agreeing to join.

Main reasons for not taking part

  • The implant was used outside its approved instructions (off label).
  • At surgery: osteoradionecrosis (bone damage from radiation), or a body-wide or local infection.
  • At surgery: nerve, muscle or blood vessel problems in the leg that could stop the implant holding firmly.
  • The surgery was a redo (revision) after an earlier hip replacement or device failed.
  • A mental illness, memory or thinking problem, or nerve disorder that stops the person giving consent or following directions.

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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:
  • 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)
  • Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
  • Systemic or local infection
  • Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
  • Osteoradionecrosis
  • Revision procedure where other treatment or devices have failed*

Where in United States

  • South Bend OrthopaedicsSouth Bend, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

The group in the trial

  • Vivacit-E Elevated Liners

    Patients previously implanted with Vivacit-E Elevated Liners.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Post-Market Clinical Follow-Up Study of the Vivacit-E Vitamin E Highly Crosslinked Polyethylene HXLPE Elevated Liners in Primary THA- A Retrospective Enrollment/Prospective Follow-Up Study
Plain-language title
Long-term follow-up of Vivacit-E hip socket liners in hip replacementGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
1 April 2026