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

No Placebo-Only Group

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.

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).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medical Devices

Secondary study objectives

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

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: 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.

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