Osteoarthritis (OA) of the HipNCT07150221
MDR Vivacit-E Elevated Study
An observational study of Osteoarthritis (OA) of the Hip and Avascular Necrosis of Bone of Hip, run by Zimmer Biomet at 1 site in United States.
Trial summary
The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip, Protrusio Acetabuli
- What is being tested?
- Vivacit-E Elevated Liners
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population should consist of a maximum of 52 subjects implanted 10 years ago with the Vivacit-E Vitamin E HXLPE Elevated Liner in total hip arthroplasty, according to the approved indications.
Who may be able to join
- Patient was 18 years of age or older and skeletally mature at the time of surgery
- Patient qualified for and underwent surgical procedure with a Vivacit-E Vitamin E HXLPE Elevated Liner to treat one of the following indications in primary THA:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Protrusio acetabuli
- Traumatic arthritis
- Slipped capital epiphysis
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- Fused hip
- Fracture of the pelvis
- Diastrophic variant
- Patient underwent surgical procedure 10 years (+ no maximum/- 182 days) prior to date of study consent
- Patient is will and able to sign IRB approved Informed Consent Form or provide verbal consent
Who cannot join
- Off label use or not according to the approved IFU at the time of surgery
- Patient presented with any of the following at the time of the surgical procedure:
- Osteoradionecrosis
- Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
- Systemic or local infection
- Revision procedure where other treatment or devices have failed*
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- Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
- Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions
- For the purpose of this clinical study; a revision procedure refers to a procedure in which the prior procedure on the ipsilateral hip utilized a similar approach (i.e., primary total hip arthoplasty)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Post-Market Clinical Follow-Up Study of the Vivacit-E Vitamin E Highly Crosslinked Polyethylene HXLPE Elevated Liners in Primary THA- A Retrospective Enrollment/Prospective Follow-Up Study
The main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
- Conditions
- Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip, Protrusio Acetabuli, Traumatic Arthropathy-Hip, Slipped Capital Femoral Epiphyses, Fused Hip
- Being tested
- Vivacit-E Elevated Liners
- Medical subject headings
- Osteoarthritis, Slipped Capital Femoral Epiphyses, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivacit-E Elevated LinersDevice
Primary total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Vivacit-E Elevated Liners | Patients previously implanted with Vivacit-E Elevated Liners. Receives: Device: Vivacit-E Elevated Liners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of the Implant System via Adverse Events
The primary endpoint is defined by the survival of the implant system at 10 years post-operative, which is based on removal of the study device and will be determined using the Kaplan Meier method. The safety of the study device will be assessed by monitoring the frequency and incidence of adverse events.
Measured: 10 years
Secondary outcomes (2)
Pain and functional performance measured by the Oxford Hip Score
The Oxford Hip Score measures pain and function together, reflecting how hip symptoms impact a patient's severity and frequency of hip-related pain and their physical capabilities.
Measured: 10 years
Subject quality-of-life measured by the EQ-5D-5L
The EQ-5D-5L is a standardized questionnaire that measures health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It provides an overall assessment of a participant's perceived health status.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start7 Jan 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA) of the HipStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150221
- Sponsor's protocol ID
- MDRG2017-89MS-106H
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up Study of the Vivacit-E Vitamin E Highly Crosslinked Polyethylene HXLPE Elevated Liners in Primary THA- A Retrospective Enrollment/Prospective Follow-Up Study
- ClinicalTrials.gov ID
- NCT07150221
- Acronym / sponsor ID
- MDRG2017-89MS-106H
- Conditions
- Osteoarthritis (OA) of the Hip, Avascular Necrosis of Bone of Hip, Protrusio Acetabuli, Traumatic Arthropathy-Hip, Slipped Capital Femoral Epiphyses, Fused Hip
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Sep 2025 (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 main objective of this study is to confirm long-term safety, performance, and clinical benefits of the Vivacit-E Vitamin E HXLPE Elevated Liners when used in primary total hip arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivacit-E Elevated Liners | – | Device: Vivacit-E Elevated LinersPatients previously implanted with Vivacit-E Elevated Liners. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population should consist of a maximum of 52 subjects implanted 10 years ago with the Vivacit-E Vitamin E HXLPE Elevated Liner in total hip arthroplasty, according to the approved indications.
Key inclusion criteria (11 listed)
- Patient was 18 years of age or older and skeletally mature at the time of surgery
- Patient qualified for and underwent surgical procedure with a Vivacit-E Vitamin E HXLPE Elevated Liner to treat one of the following indications in primary THA:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Protrusio acetabuli
- Traumatic arthritis
Key exclusion criteria (9 listed)
- Off label use or not according to the approved IFU at the time of surgery
- Patient presented with any of the following at the time of the surgical procedure:
- Osteoradionecrosis
- Neuromuscular compromise, vascular deficiency or other conditions in the affected limb that may lead to inadequate skeletal fixation
- Systemic or local infection
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 Elevated LinersPrimary total hip arthroplasty | Device | Vivacit-E Elevated Liners |
Primary outcome
Survival of the Implant System via Adverse Events
Time frame: 10 years
The primary endpoint is defined by the survival of the implant system at 10 years post-operative, which is based on removal of the study device and will be determined using the Kaplan Meier method. The safety of the study device will be assessed by monitoring the frequency and incidence of adverse events.
2 secondary outcomes
Pain and functional performance measured by the Oxford Hip Score
Time frame: 10 years
Subject quality-of-life measured by the EQ-5D-5L
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis (OA) of the Hip and Avascular Necrosis of Bone of Hip, run by Zimmer Biomet at 1 site 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 11 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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 Implant System via Adverse Events (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 1 Apr 2026.