New hip liner under Long-Term watch: will it hold up?
NCT ID NCT05587244
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
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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
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About 202 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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Dec 2038
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Get notified about this study
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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.
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The places running it
10 sites. The list below names each one and where it is.
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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.
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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
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Jersey City Medical Center, Inc
Livingston, New Jersey, 07039, United States
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Medical City Plano
Plano, Texas, 75075, United States
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TOA Research Foundation
Knoxville, Tennessee, 37923, United States
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The Ohio State University
Columbus, Ohio, 43201, United States
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The University of Texas Health Science Center of Houston
Houston, Texas, 77030, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35205, United States
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University of Florida Board of Trustees
Gainesville, Florida, 32611, United States
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University of Southern California
Los Angeles, California, 90033, United States
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University of Utah
Salt Lake City, Utah, 84108, United States
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West Virginia University
Morgantown, West Virginia, 26506, United States
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Other studies related to the condition(s) this trial covers.
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