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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
Must not have
Rheumatoid Arthritis
The patient has an acute, chronic, or systemic infection(s)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a special hip replacement part made from durable plastic in patients needing hip surgery. The goal is to see if it reduces wear and tear, improves pain, and enhances movement.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Rheumatoid Arthritis.
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I am currently dealing with an infection.
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I have inflammatory arthritis.
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I am missing some or all of my muscle or ligament structure.
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My bones are still growing.
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My bones near the joint surgery area are not strong enough for a good implant fit.
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I have conditions in my limb that may affect bone healing.
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I have bone damage due to radiation therapy.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Osteoarthritis (OA) include analgesics like acetaminophen, which reduce pain by inhibiting pain signals in the brain, and nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen, which alleviate pain and inflammation by inhibiting cyclooxygenase enzymes (COX-1 and COX-2). Glucocorticoids, administered orally or via intraarticular injections, provide potent anti-inflammatory effects by suppressing multiple inflammatory pathways. For patients with severe OA, joint replacement using materials like High Cross-Linked Polyethylene (HXPE) liners is crucial as these materials reduce wear and improve the durability of the joint prosthesis, thereby enhancing joint function and longevity. Understanding these mechanisms helps patients and clinicians choose appropriate treatments to manage symptoms effectively and improve quality of life.
Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study.

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
375 Previous Clinical Trials
67,275 Total Patients Enrolled
130 Trials studying Osteoarthritis
32,922 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,731 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,880 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
~28 spots leftby Mar 2026