OsteoarthritisNCT03226808
Vivacit-E Post-market Follow-up Study
A study testing Vivacit-E Liner in people with Osteoarthritis and Avascular Necrosis of Bone of Hip, run by Zimmer Biomet at 5 sites in United States.
Trial summary
The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis of Bone of Hip, Post-traumatic; Arthrosis
- What is being tested?
- Vivacit-E Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2013to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Texas Institute for Hip and Knee Surgery
Austin, Texas, 78751
Department of Orthopaedics University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Denver Hip and Knee, Inc.
Parker, Colorado, 80134
Rothman Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell
The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.
Read the detailed description
Safety will be evaluated by monitoring the frequency and incidence of adverse events.
Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell.
In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear at 6 weeks and 1, 2, \& 5 years postoperatively.
Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.
- Conditions
- Osteoarthritis, Avascular Necrosis of Bone of Hip, Post-traumatic; Arthrosis, Congenital Hip Dysplasia
- Being tested
- Vivacit-E Liner
- Medical subject headings
- Osteoarthritis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivacit-E LinerDevice
All subjects enrolled will receive the Vivacit-E liner.
| Study group | Role | What they receive |
|---|---|---|
| Vivacit-E Liner | Other | All subjects enrolled receive the study implant. Receives: Device: Vivacit-E Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the study device; whether or not it is still implanted in the subject
Survival is classified as removal of the study device for any reason
Measured: 10 years
Secondary outcomes (5)
Incidence of treatment-emergent Adverse Events (safety)
Safety is assessed by monitoring the frequency and incidence of all adverse events, with particular focus on those that may be related to the study device.
Measured: 10 years
Harris Hip Score
Functional outcomes are measured with the Harris Hip Score, including range of motion, pain level, activity levels and patient satisfaction.
Measured: 10 years
Patient activity level
Patient activity level is assessed with the High Activity Arthroplasty score, filled out by the patient.
Measured: 10 years
Patient Quality of Life
This is another self-assessment by means of the EQ-5D score, which measures the patient's perceived quality of life.
Measured: 10 years
Radiographic analysis
Patient x-rays will undergo an analysis to evaluate radiolucencies, osteolysis, subsidence, cup migration and polyethylene wear.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Oct 2013
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Boylan, MBA, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226808
- Sponsor's protocol ID
- CMU2011-09H
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2016
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up Study of the Zimmer Vivacit-E Highly Crosslinked Polyethylene Liner Used With the Continuum Acetabular Shell
- ClinicalTrials.gov ID
- NCT03226808
- Acronym / sponsor ID
- CMU2011-09H
- Conditions
- Osteoarthritis, Avascular Necrosis of Bone of Hip, Post-traumatic; Arthrosis, Congenital Hip Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This will be done by analysis of polyethylene wear, validated outcome measurement tools, radiographs, and reported adverse events data.
Detailed description
Safety will be evaluated by monitoring the frequency and incidence of adverse events.
Performance will be determined by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Vivacit-E HXPE Liner with the Continuum acetabular shell.
In addition, the implanted Vivacit-E HXPE Liners will be evaluated for bedding in, and linear and volumetric wear at 6 weeks and 1, 2, \& 5 years postoperatively.
Pain and functional performance will be measured using the Harris Hip and High Activity Arthroplasty Scores. Survivorship will be based on removal or intended removal of the device and through analysis of radiographs, and health status will be determined by evaluation of the EQ-5D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivacit-E Liner | Other | Device: Vivacit-E LinerAll subjects enrolled receive the study implant. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivacit-E LinerAll subjects enrolled will receive the Vivacit-E liner. | Device | Vivacit-E Liner |
Primary outcome
Survival of the study device; whether or not it is still implanted in the subject
Time frame: 10 years
Survival is classified as removal of the study device for any reason
5 secondary outcomes
Incidence of treatment-emergent Adverse Events (safety)
Time frame: 10 years
Harris Hip Score
Time frame: 10 years
Patient activity level
Time frame: 10 years
Patient Quality of Life
Time frame: 10 years
Radiographic analysis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Boylan, MBA study director
Zimmer Biomet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivacit-E Liner in people with Osteoarthritis and Avascular Necrosis of Bone of Hip, run by Zimmer Biomet at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of the study device; whether or not it is still implanted in the subject (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.