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New hip liner tracked for 10 years: will it last?

NCT ID NCT07150221

Disease control Sponsor: Zimmer Biomet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 52 people who already received a Vivacit-E hip liner during total hip replacement. Researchers will track how long the implant lasts and any problems over 10 years. The goal is to confirm the liner is safe and helps reduce pain and improve movement for conditions like arthritis or hip injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vivacit-E Vitamin E highly crosslinked polyethylene elevated liner (a medical device used in hip replacement surgery)
What this could lead to
If successful, this study could confirm that the Vivacit-E liner is safe and works well for at least 10 years, helping people with hip pain move better.
What could go wrong
This is a small, observational study with only 52 people, so results may not apply to everyone. The device could still fail or cause complications over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

avascular necrosis diastrophic dysplasia epiphysiolysis of the hip hip fracture osteoarthritis osteoarthritis, hip Protrusio acetabuli

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Avascular necrosis of bone of hip Diastrophic variant Fracture of pelvis Fused hip Osteoarthritis (OA) of the hip Protrusio acetabuli Slipped capital femoral epiphyses Traumatic arthropathy-hip

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • South Bend Orthopaedics

    South Bend, Indiana, 46635, United States

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Other studies related to the condition(s) this trial covers.