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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 10 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am an adult and my bones have stopped growing.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Event (safety)
Survival of the study device (liner); whether or not it is still implanted in the subject
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,097 Total Patients Enrolled
Hillary OverholserStudy DirectorZimmer Biomet
10 Previous Clinical Trials
2,400 Total Patients Enrolled
Kacy Arnold, MBAStudy DirectorZimmer Biomet
4 Previous Clinical Trials
504 Total Patients Enrolled

Media Library

G7 Acetabular System (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04754087 — N/A
Total Hip Replacement Research Study Groups: G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners
Total Hip Replacement Clinical Trial 2023: G7 Acetabular System Highlights & Side Effects. Trial Name: NCT04754087 — N/A
G7 Acetabular System (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04754087 — N/A

Frequently Asked Questions

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

What results are researchers hoping to achieve from this trial?

"The primary metric monitored over 10 years for safety is Adverse Events. Secondary outcomes encompass patient Quality of Life measured via the EQ-5D-5L EQ visual analogue scale (0 to 100, with higher scores being better) and pain/function assessed through Modified Harris Hip Score (0 to 100, high scores denote better results) as well as Oxford Hip Score (0 - 48; highest score represents best outcome)."

Answered by AI

Is enrollment for this clinical trial currently accessible?

"Affirmative. The clinical trial is actively seeking participants, as indicated by the information hosted on clinicaltrials.gov. This medical research project was first posted on July 7th 2021 and recently edited on October 18th 2022; 300 patients are needed across 6 sites for this study to be successful."

Answered by AI

What number of health facilities are hosting this experiment?

"This clinical trial is accepting participants at Duke University Medical Centre, Colorado Joint Replacement and the University of Utah Health in addition to 6 other sites."

Answered by AI

How many participants are currently taking part in this clinical experiment?

"For the successful execution of this study, Zimmer Biomet needs to recruit 300 participants who meet the eligibility criteria. Expansion efforts will be focused on Duke University Medical Centre in Durham and Colorado Joint Replacement in Denver."

Answered by AI

Who else is applying?

What site did they apply to?
Colorado Joint Replacement
South Bend Orthopaedics
Duke University Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have osteoarthritis in back, knees, hands, and have been treated by UC Health for 3 years.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Colorado Joint Replacement: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
2021. "G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04754087.
All > Rheumatoid Arthritis > Ra
~200 spots leftby Dec 2033
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