Can a new plastic hip liner outlast the old ones?

NCT ID NCT03226808

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 ยท Last updated Sep 04, 2026

Summary

This study tracks 245 adults aged 18 to 60 who receive a Vivacit-E liner during hip replacement surgery. The liner is a plastic cup that fits inside the hip socket to allow smooth movement. Researchers measure how long the liner stays in place without needing removal, and they check wear, function, and safety through X-rays and patient questionnaires. The goal is to see if this liner holds up well in younger, more active patients who may put more stress on their new hip.

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 highly crosslinked polyethylene liner, a plastic component used in hip replacement surgery
What this could lead to
If the liner proves durable, it could mean fewer repeat hip surgeries for younger patients who need a hip replacement.
What could go wrong
This is an observational follow-up study, not a controlled trial, so it cannot prove the liner is better than other options. The liner may 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

245 people

The number who actually took part.

Started

Oct 2013

Finished

Apr 2026

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 to 60 years

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 is 18 to 60 years of age, inclusive. * Patient is skeletally mature. * Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including at least one of the following: * Osteoarthritis * Avascular necrosis (AVN) * Post-traumatic arthritis * Congenital hip dysplasia * Patient has no history of previous total hip replacement or arthrodesis of the affected hip joint(s). * Patient is willing and able to provide written informed consent. * Patient is willing and able to cooperate in the required post-operative therapy. * Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent. * Patient has participated in the Informed Consent process and has signed the IRB/EC approved informed consent. Exclusion Criteria: * Patient is unwilling or unable to give consent or to comply with the follow-up program. * Patient has a total prosthetic hip replacement device (including surface replacement arthroplasty, endoprosthesis, etc. in the affected hip joint(s). * Inflammatory Arthritis * Rheumatoid Arthritis * The patient is: * a prisoner mentally incompetent or unable to understand what participation in the study entails a known alcohol or drug abuser * anticipated to be non-compliant * The patient has an acute, chronic, or systemic infection(s). * The patient has total or partial absence of the muscular or ligamentous apparatus. * The patient has neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation. * The patient has osteoradionecrosis. * The patient has lack of bony structures proximal or distal to the operative joint, so that good implant fixation is unlikely or impossible. * The patient has local bone tumors/cysts in the bone to be retained that the implanting surgeon determines could inhibit implant fixation. * The patient is skeletally immature. * The patient has any concomitant disease that can jeopardize the functioning and the success of the implant. * The patient is known to be pregnant. * The patient has a known sensitivity or allergic reaction to one or more of the implanted materials which include metal (titanium, tivanium, tantalum, cobalt, chromium, nickel) and ceramic.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Denver Hip and Knee, Inc.

    Parker, Colorado, 80134, United States

  • Department of Orthopaedics University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

  • Rothman Institute

    Philadelphia, Pennsylvania, 19107, United States

  • Texas Institute for Hip and Knee Surgery

    Austin, Texas, 78751, United States

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