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Orthopedic Implant

Hip Replacement Liners for Osteoarthritis

N/A

Recruiting

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must be a legal adult who has reached full skeletal maturity.

Be older than 18 years old

Must not have

Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease.

Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the long-term safety and benefits of a new hip replacement system.

Who is the study for?

This trial is for adults with full skeletal maturity who need hip replacement due to conditions like osteoarthritis or fractures. Candidates must be able to follow the study protocol and attend follow-up visits. Pregnant individuals, those with bone formation disorders, severe osteoporosis, infections that could affect the implant site, substance abuse issues, or unmanageable neuromuscular diseases cannot participate.

What is being tested?

The study aims to confirm safety and effectiveness of G7 Acetabular Shells used with Vivacit-E and Longevity HXLPE liners in primary and revision total hip replacements. It's designed to track long-term outcomes in patients receiving these specific hip implant components.

What are the potential side effects?

While not explicitly listed here, typical side effects from similar hip replacement devices may include pain at the surgery site, inflammation around the implant, risk of dislocation or loosening of the implant over time, infection risks associated with surgery and possible reaction to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult and my bones have stopped growing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition affecting my blood vessels, muscles, or nerves.

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I am unable to follow study directions due to a neurological condition or personal reasons.

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I have severe joint damage and bone loss visible on X-rays.

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I have an infection that could spread to the surgery area.

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I have been diagnosed with osteomalacia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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

Adverse Event (safety)

Survival of the study device (liner); whether or not it is still implanted in the subject

Secondary study objectives

Pain and Function using Modified Harris Hip Score

Pain and Function using Oxford Hip Score

Patient Quality of Life using EQ-5D-5L Descriptive System

+1 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: G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene LinersExperimental Treatment1 Intervention

Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up.

0 / 6Eligibility criteria met