Vivacit-E Liner for Hip Osteoarthritis

Recruiting in Charlotte (>99 mi)

+4 other locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Inflammatory arthritis, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery and immediate postoperative period

258 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the Vivacit-E Liner treatment different from other hip osteoarthritis treatments?

The Vivacit-E Liner is unique because it uses a vitamin E-infused, highly cross-linked polyethylene material, which is designed to reduce wear and oxidative degradation, potentially leading to longer-lasting hip replacements compared to traditional materials. ^{1 2 3 4 5}

Who Is on the Research Team?

Ryan Boylan, MBA

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing and able to follow the required treatment after surgery.

My bones have stopped growing.

I need a hip replacement due to conditions like osteoarthritis or hip dysplasia.

Exclusion Criteria

The patient is known to be pregnant

I have been diagnosed with Rheumatoid Arthritis.

I am currently dealing with an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Vivacit-E HXPE Liner with the Continuum acetabular shell implant

Surgery and immediate postoperative period

Initial Follow-up

Initial evaluation of the implanted Vivacit-E HXPE Liners for bedding in, and linear and volumetric wear

6 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for safety, device survivorship, and functional outcomes using various scores and radiographic analysis

10 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Vivacit-E Liner

Trial Overview 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.

How Is the Trial Designed?

Group I: Vivacit-E Liner Experimental Treatment 1 Intervention

All subjects enrolled receive the study implant.

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Citations

1. Sweden pubmed.ncbi.nlm.nih.gov

Performance of thin Vivacit-E hip liners: no relevant wear during ex vivo testing at high acetabular inclination angle. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Safety of vitamin E-infused highwall liners for routine use in primary total hip arthroplasty: single centre, short-term follow-up of 1221 cases. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Minimum 7-Year Follow-Up of Vitamin E-Diffused and Highly Cross-Linked Polyethylene Liners in Total Hip Arthroplasty: Findings From a Prospective, International, Multicenter Study of 977 Patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Early unexpected failure of a vitamin E-infused highly cross-linked polyethylene liner: A case report. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Early Fracture of a Vitamin-E-Infused, Highly Cross-Linked Polyethylene Liner After Total Hip Arthroplasty: A Case Report. [2021]