Vivacit-E Liner for Hip Osteoarthritis

Not currently recruiting at 4 trial 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the effectiveness of the Vivacit-E Liner for individuals needing a hip replacement due to conditions such as osteoarthritis or hip dysplasia. Researchers focus on the liner's performance, durability, and any potential issues it might cause. Those who have not undergone hip replacement surgery and require one due to hip problems like osteoarthritis may find this trial suitable. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future hip replacement options.

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.

What prior data suggests that the Vivacit-E Liner is safe for hip osteoarthritis?

Research shows that the Vivacit-E Liner, used in hip replacements, is generally well-tolerated. Studies have examined its long-term safety and effectiveness, yielding promising results. Research on similar liners suggests they help prevent issues like bone loss and implant loosening, keeping the implant secure without infection. This can reduce the need for additional surgeries.

Long-term studies also assess safety and function, and so far, the liners have demonstrated high success rates. These findings suggest that the Vivacit-E Liner is safe for use in hip osteoarthritis, with few side effects reported. This is encouraging news for those considering participation in related clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for hip osteoarthritis, which include pain relief medications and physical therapy, the Vivacit-E Liner offers a unique approach by using an advanced implant technology. Researchers are excited about this treatment because it features a highly durable and wear-resistant polyethylene material that aims to improve joint function and longevity. This could potentially reduce the need for revision surgeries and enhance the quality of life for patients with hip osteoarthritis.

What evidence suggests that the Vivacit-E Liner is effective for hip osteoarthritis?

Research shows that the Vivacit-E Liner, used in hip replacements, is designed for improved performance and longevity. This liner incorporates Vitamin E to strengthen the plastic material, enhancing its resistance to wear over time. Studies have found that these liners can improve hip replacement function and reduce damage, leading to better outcomes. The goal is to provide long-lasting benefits, making it a promising choice for individuals with hip osteoarthritis. Early findings suggest that this liner could be a durable option for those needing hip surgery. Participants in this trial will receive the Vivacit-E Liner as the study implant. ^{1 5 6 7 8}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT03226808

NCT03226808 | Vivacit-E Post-market Follow-up Study The objectives of this study are to obtain clinical performance (outcomes) data and survivorship for commercially available Vivacit-E (HXPE) liners. This ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07150221

NCT07150221 | MDR Vivacit-E Elevated 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 ...

3. withpower.com withpower.com/trial/phase-osteonecrosis-9-2013-12e52

Vivacit-E Liner for Hip Osteoarthritis 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8668289/

Vitamin E-Enhanced Liners in Primary Total Hip Arthroplasty Vitamin E injected into high-molecular-weight polyethylene can produce stable oxidation resistance, improve the mechanical properties of the cushion, and ...

5. trials.arthritis.org trials.arthritis.org/trials/NCT04754087

G7 Acetabular System With Vivacit-E or Longevity Liner PMCF ... The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit ...

6. trials.arthritis.org trials.arthritis.org/trials/NCT07150221

MDR Vivacit-E Elevated Study - Clinical Trial Finder 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 ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05587244?term=AREA%5BBasicSearch%5D(vivacit)&rank=1

NCT05587244 | G7 Freedom Constrained Vivacit-E Liners The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit -E Acetabular ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11446611/

Ten-year clinical and radiological outcomes with a vitamin ... Isoelastic VEPE cups offer high success rates and may prevent osteolysis, aseptic loosening, and the need for revision surgeries in the long term.