ClinicalTrials.gg
Enrolling by invitationNCT07150221Updated Apr 1, 2026

MDR Vivacit-E Elevated Study

An observational study in Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip and Protrusio Acetabuli, sponsored by Zimmer Biomet. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Zimmer Biomet · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
52
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 101 studies in Osteoarthritis by Zimmer Biomet — 4 open to participants now, 24 under way, none of them phase 3. Osteoarthritis · Zimmer Biomet.

Planned enrollment
41st of 53
52 · median 118
Started
2026
the only one that year
Observational
53 of 101
3 open now
Primary completion
2027-12
later than 9 of 23 live
Registered
100th of 101
by date

Among the 101 studies in Osteoarthritis by Zimmer Biomet, this one is the 41st largest by planned enrollment of the 53 observational ones that give a count, is the only one that started in 2026, is one of 53 observational ones, reaches primary completion later than 9 of the 23 other live ones, and was the 100th registered.

Osteoarthritis

2,974 studies on the registry are indexed under Osteoarthritis; 435 are open to participants now.

Browse Osteoarthritis studies →

Open to participants now

4 of the 101 studies in Osteoarthritis by Zimmer Biomet are open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Who these studies take

Of the 285 Osteoarthritis studies recruiting now, 157 (55%) set no upper age limit and 71 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 101 studies in Osteoarthritis by Zimmer Biomet, or all of them as a file.
02

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population should consist of a maximum of 52 subjects implanted 10 years ago with the Vivacit-E Vitamin E HXLPE Elevated Liner in total hip arthroplasty, according to the approved indications.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Form or provide verbal consent

Exclusion criteria

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
  • 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
52 participants (estimated)
Patient registry
No

Groups and cohorts

  • Vivacit-E Elevated Liners

    Patients previously implanted with Vivacit-E Elevated Liners.

    Device: Vivacit-E Elevated Liners

Interventions

  • DeviceVivacit-E Elevated Liners

    Primary total hip arthroplasty

06

What researchers measure

Primary outcomes

  1. Survival of the Implant System via Adverse Events

    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.

    Time frame: 10 years

Secondary outcomes

  1. Pain and functional performance measured by the Oxford Hip Score

    The Oxford Hip Score measures pain and function together, reflecting how hip symptoms impact a patient's severity and frequency of hip-related pain and their physical capabilities.

    Time frame: 10 years

  2. Subject quality-of-life measured by the EQ-5D-5L

    The EQ-5D-5L is a standardized questionnaire that measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides an overall assessment of a participant's perceived health status.

    Time frame: 10 Years

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Dec 2027, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2025
First posted
Sep 2, 2025
StartActual
Jan 7, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Apr 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07150221
Lead sponsor
Zimmer Biomet
Responsible party
Sponsor
First posted
Sep 2, 2025
Start date
Jan 7, 2026
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Apr 1, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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