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New hip liner under Long-Term watch: will it hold up?

NCT ID NCT05587244

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is following 202 people who received a special hip liner during hip replacement surgery. The goal is to see how long the liner lasts and whether it causes any problems over time. Participants are adults aged 18 to 80 with conditions like arthritis or hip fractures. The study will track device survival and any side effects for up to 10 years.

What this could mean

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

Active substance
G7 Freedom Constrained Vivacit-E Acetabular Liners (a medical device used in hip replacement surgery)
What this could lead to
If successful, this study could confirm that this hip liner is safe and works well over the long term, helping people with hip problems get a reliable replacement option.
What could go wrong
This is an observational follow-up study, not a randomized trial, so results may not apply to everyone. The device could still fail or cause complications like dislocation or infection 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 202 people

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

Started

May 2023

Expected to finish

Dec 2038

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 to 80 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 80 years of age, inclusive * Patient is skeletally mature * Patient qualifies for unilateral total hip arthroplasty based on physical exam and medical history including at least one of the following: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis * Rheumatoid arthritis * High risk for dislocation * Undergoing revision hip arthroplasty * Correction of functional deformity * In need of treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Patient is willing and able to complete scheduled follow-up evaluations as described in the protocol and Informed Consent * Patient, or the patient's legally authorized representative, has participated in the Informed Consent process and is willing and able to sign an IRB approved informed consent Exclusion Criteria: * Patient is septic, has an active infection or has osteomyelitis at the affected joint * Patient has significant osteoporosis as defined by treating surgeon * Patient has metabolic disorder(s) which may impair bone formation * Patient has osteomalacia * Patient has distant foci of infections which may spread to the implant site * Patient has rapid joint destruction, marked bone loss or bone resorption on pre-operative radiographs * Patient underwent contralateral THA within 3 months of planned index procedure or has a contralateral THA planned within 3 months of the index procedure * Patient is undergoing simultaneous bilateral THA * Patient has vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease which might jeopardize the outcome of the surgery. * In the opinion of the investigator, patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant * Patient is known to be pregnant * The patient is in the vulnerable population group, such as * a prisoner * a known alcohol or drug abuser * mentally incompetent or unable to understand what participation in this study entails

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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.

How to take part

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

  1. The places running it

    10 sites. 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

  • Jersey City Medical Center, Inc

    Livingston, New Jersey, 07039, United States

  • Medical City Plano

    Plano, Texas, 75075, United States

  • TOA Research Foundation

    Knoxville, Tennessee, 37923, United States

  • The Ohio State University

    Columbus, Ohio, 43201, United States

  • The University of Texas Health Science Center of Houston

    Houston, Texas, 77030, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205, United States

  • University of Florida Board of Trustees

    Gainesville, Florida, 32611, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • West Virginia University

    Morgantown, West Virginia, 26506, United States

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