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Hip replacement liners put to the test in global study

NCT ID NCT04754087

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study follows 300 people who receive a hip replacement using either the Vivacit-E or Longevity liner, both made of a special plastic designed to last longer. The goal is to see how well these liners hold up over time, measuring how many are still in place without needing replacement and tracking any side effects. Participants include adults with hip conditions like osteoarthritis, rheumatoid arthritis, or hip fractures.

What this could mean

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

Active substance
two types of hip replacement liners: Vivacit-E and Longevity highly crosslinked polyethylene (HXLPE)
What this could lead to
If successful, this study could confirm that these liners are safe and effective for long-term use in hip replacements, potentially reducing the need for revision surgery.
What could go wrong
This is an observational follow-up study, not a randomized controlled trial, so results may be influenced by patient selection. The liners may still wear out 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

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

Started

Jul 2021

Expected to finish

Dec 2033

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 must be a legal adult who has reached full skeletal maturity. * Patient must be treated for one of the following indications: * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Revision procedures where other treatment or devices have failed * Patient must be able and willing to complete the protocol required follow-up visits. * Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent. Exclusion Criteria: * Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device. * Patient has a metabolic disorder that may impair bone formation. * Patient has osteomalacia. * Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis. * Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram. * Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * Patient is pregnant.

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Conditions

The condition(s) this trial relates to.

avascular necrosis avascular necrosis of femoral head, primary, 1 familial avascular necrosis of femoral head femoral neck fracture hip fracture osteoarthritis susceptibility 5 osteoarthritis, hip rheumatoid arthritis

As listed by the trial registrant

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

Avascular necrosis of hip Degenerative joint disease of hip Fracture of hip Fractures, hip Osteoarthritis hip Osteoarthritis of hip Rheumatoid arthritis of hip Total hip arthroplasty

Contacts and locations

Locations

  • Colorado Joint Replacement

    Denver, Colorado, 80210, United States

  • Copenhagen University Hospital Hvidovre

    Hvidovre, 2650, Denmark

  • Duke University Medical Center

    Durham, North Carolina, 27703, United States

  • OCON Hengelo

    Hengelo, Netherlands

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Skane University Hospital

    Lund, 221 85, Sweden

  • Slocum Center for Orthopedics & Sports Medicine

    Eugene, Oregon, 97401, United States

  • South Bend Orthopaedics

    South Bend, Indiana, 46635, United States

  • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital

    Bournemouth, UK, BH7 7DW, United Kingdom

  • University of Utah Health

    Salt Lake City, Utah, 84112, United States

  • Zuyderland Hospital

    Geleen, 6162 BG, Netherlands

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