What side effects are associated with this type of intervention?

Common treatments for osteoarthritis include joint replacement surgery, NSAIDs, and intraarticular injections. Joint replacement, such as with Vivacit-E (HXPE) Liners, can lead to complications like infection, blood clots, and prosthesis wear or failure. NSAIDs, used for pain relief, can cause gastrointestinal issues, cardiovascular risks, and kidney damage. Intraarticular injections, such as glucocorticoids, may provide short-term relief but can lead to joint infection, increased pain, and cartilage damage with repeated use.

What prior FDA approvals exist?

The FDA has approved various treatments for osteoarthritis, particularly focusing on joint replacement materials and techniques. High Cross-Linked Polyethylene (HXPE) liners, like the Vivacit-E liners, are designed to reduce wear and improve the durability of joint replacements. These liners are used in hip and knee arthroplasties to enhance the longevity of the prosthetic joints. Other related FDA-approved treatments include different types of polyethylene materials and advanced ceramic and metal components used in joint replacements to improve outcomes and reduce complications such as wear and osteolysis.

What other types of research exist?

Promising novel alternatives to Vivacit-E (HXPE) liners for osteoarthritis treatment in 2024 include: 1) Biocompatible hydrogels composed of sulfated glycosaminoglycans and cationic cellulose, which have shown potential in animal models for treating osteoarthritis. 2) Chitosan-Hyaluronate hybrid gel (CHHG), a thermo-responsive hydrogel that has demonstrated efficacy in delaying osteoarthritis progression and reducing pain in rat models. These alternatives offer innovative approaches to joint preservation and symptom management.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

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.

0 / 16Eligibility criteria met

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.