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Acetabular Liner

Hip Implant for Hip Replacement

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study Summary

This trial will check the long-term safety & benefits of hip implants for hip replacement surgery.

Who is the study for?

This trial is for adults aged 18-80 with joint diseases like osteoarthritis or avascular necrosis, rheumatoid arthritis, high risk of hip dislocation, or those needing revision hip surgery. It's also for patients with certain types of hip fractures that can't be treated by other methods. Participants must be able to follow the study plan and give informed consent.Check my eligibility

What is being tested?

The trial is testing G7 Freedom Constrained Vivacit-E Liners in total hip replacements to see if they're safe and effective over the long term. This includes both first-time surgeries and revisions (re-doing previous surgeries).See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include pain at the surgery site, infection, inflammation around the implant, dislocation of the new joint liner, wear-and-tear on the implant over time leading to additional surgeries.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Medical Devices

Secondary outcome measures

Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)

Incidence of treatment-emergent Adverse Events (safety)

Pain and Functional Performance - Modified Harris Hip Score

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Total Hip Arthroplasty Treatment GroupExperimental Treatment1 Intervention

This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor

373 Previous Clinical Trials

67,195 Total Patients Enrolled

54 Trials studying Rheumatoid Arthritis

10,732 Patients Enrolled for Rheumatoid Arthritis

Hillary OverholserStudy DirectorZimmer Biomet

10 Previous Clinical Trials

2,498 Total Patients Enrolled

5 Trials studying Rheumatoid Arthritis

1,371 Patients Enrolled for Rheumatoid Arthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applications being accepted for this research project at the present time?

"As per clinicaltrials.gov, this investigation is no longer accepting participants as it was last updated on November 9th 2023 - after its initial posting date of May 8th 2023. Fortunately, there are 768 other trials currently looking for individuals to join them in their research."

Answered by AI

Does this clinical trial accept volunteers younger than fifty years of age?

"According to the inclusion criteria, patients between 18 and 80 years old can apply for this trial. Moreover, there are 105 studies available for minors and 658 trials suitable for those above 65."

Answered by AI

Who meets the stipulations for participation in this medical experiment?

"This clinical trial is currently accepting 202 patients aged between 18-80 suffering from hip dislocation. Candidates must meet the following criteria: Be of legal age, skeletally mature, exhibit non-inflammatory degenerative joint disease (including osteoarthritis and avascular necrosis), have a high risk for dislocation, be undergoing revision hip arthroplasty or require treatment for femoral neck fractures with head involvement that cannot be treated by other methods; agree to complete follow up evaluations as described in the protocol's informed consent document; and willingly sign an approved IRB Informed Consent form."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

G7 Freedom Constrained Vivacit-E Liners

2023. "G7 Freedom Constrained Vivacit-E Liners". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05587244.

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