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Vivacit-E Liner for Hip Osteoarthritis

N/A
Waitlist Available
Research Sponsored by Zimmer Biomet
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is 18 to 60 years of age, inclusive
Patient is skeletally mature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial is testing how well a hip replacement liner lasts and how well patients do who have this liner.

Who is the study for?
This trial is for adults aged 18-60 with hip conditions like osteoarthritis or avascular necrosis who need a new hip joint (total hip arthroplasty). They must be skeletally mature, have not had previous hip replacements on the affected side, and be able to follow the study's procedures and visits.Check my eligibility
What is being tested?
The Vivacit-E Liner used in total hip replacements is being studied. Researchers want to see how well it performs by looking at wear over time, patient outcomes through surveys and x-rays, and any reported problems.See study design
What are the potential side effects?
Possible side effects may include pain around the implant site, infection risks associated with surgery, allergic reactions if sensitive to materials in the liner such as metal or ceramic components, dislocation of the new joint, or bone damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old.
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My bones have stopped growing.
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I need a hip replacement due to conditions like osteoarthritis or hip dysplasia.
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I have never had a total hip replacement or fusion surgery on my hip.
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I have arthritis caused by a past injury.
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I am between 18 and 60 years old.
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My bones have stopped growing.
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I have been diagnosed with avascular necrosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival of the study device; whether or not it is still implanted in the subject
Secondary outcome measures
Harris Hip Score
Incidence of treatment-emergent Adverse Events (safety)
Patient Quality of Life
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vivacit-E LinerExperimental Treatment1 Intervention
All subjects enrolled receive the study implant.

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,137 Total Patients Enrolled
129 Trials studying Osteoarthritis
32,866 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,744 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,893 Patients Enrolled for Osteoarthritis
Ryan Boylan, MBAStudy DirectorZimmer Biomet
2 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

Vivacit-E Liner Clinical Trial Eligibility Overview. Trial Name: NCT03226808 — N/A
Osteoarthritis Research Study Groups: Vivacit-E Liner
Osteoarthritis Clinical Trial 2023: Vivacit-E Liner Highlights & Side Effects. Trial Name: NCT03226808 — N/A
Vivacit-E Liner 2023 Treatment Timeline for Medical Study. Trial Name: NCT03226808 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical locations are currently conducting this trial?

"Currently, the study can be found operating in 5 distinct locations. Chapel Hill, Parker and Philadelphia are some of those places. For convenience purposes it is advised to select the closest site to help reduce travel costs if you choose to take part."

Answered by AI

Does this research restrict participation to those aged 60 or over?

"This medical study is recruiting patients aged 18 to 60."

Answered by AI

What is the eligibility criteria for participation in this medical trial?

"To be eligible for this investigation, patients must have arthrosis and their ages should range from 18 to 60 years. Approximately 258 participants are needed for the study."

Answered by AI

Are there any open spots to participate in this clinical experiment?

"Clinicaltrials.gov suggests that this particular study has ceased recruitment at the moment, as its last update occurred on May 2nd 2022. Initially posted in October 2013, it is no longer looking for patients; however, a multitude of other trials have begun seeking participants recently."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Texas Institute for Hip and Knee Surgery
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Vivacit-E Post-market Follow-up Study
2013. "Vivacit-E Post-market Follow-up Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03226808.
All > Osteoarthritis
~38 spots leftby Mar 2026
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