Can a new plastic hip liner outlast the old ones?
NCT ID NCT03226808
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
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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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245 people
The number who actually took part.
- Started
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Oct 2013
- Finished
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Apr 2026
- 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 60 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 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
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Denver Hip and Knee, Inc.
Parker, Colorado, 80134, United States
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Department of Orthopaedics University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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OrthoCarolina Research Institute
Charlotte, North Carolina, 28207, United States
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Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
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Texas Institute for Hip and Knee Surgery
Austin, Texas, 78751, United States
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