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Orthopedic Implant
Avenir Complete Femoral Stem for Hip Arthritis
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
Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases
Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR), acute traumatic fracture of the femoral head or neck, avascular necrosis of the femoral head
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study Summary
This trial is testing a new type of hip replacement to see if it is safe and effective.
Who is the study for?
This trial is for adults over 20 with advanced joint wear from conditions like osteoarthritis, or those who've had failed hip surgeries. Participants must understand and follow the study's instructions, consent to join, and commit to follow-up. Excluded are pregnant individuals, metal allergies, plans to relocate soon, certain diseases affecting implant success or those unable to comply.Check my eligibility
What is being tested?
The Avenir Complete femoral stem is being tested in patients needing primary total hip replacement or revisions due to various joint issues. The study aims to confirm its long-term safety and effectiveness.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical risks associated with hip replacement surgery such as pain at the site of surgery, infection risk around the new implant, possible allergic reactions if sensitivity exists towards materials used in the femoral stem.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My joint is severely damaged due to arthritis or injury.
Select...
I had hip surgery before that didn't work, including a hip replacement or surgery for a broken hip or dead bone tissue in the hip.
Select...
I am 20 years old or older and my bones have stopped growing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival of the study device; whether or not it is still implanted in the subject
Secondary outcome measures
Harris Hip Score
Incidence of treatment-emergent Adverse Events (safety)
Oxford Hip Score
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Avenir Complete Femoral StemExperimental Treatment1 Intervention
All enrolled subjects receive the study implant
Find a Location
Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,095 Total Patients Enrolled
129 Trials studying Osteoarthritis
32,824 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,702 Total Patients Enrolled
11 Trials studying Osteoarthritis
2,851 Patients Enrolled for Osteoarthritis
Ryan BoylanStudy DirectorZimmer Biomet
2 Previous Clinical Trials
655 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My joint is severely damaged due to arthritis or injury.I had hip surgery before that didn't work, including a hip replacement or surgery for a broken hip or dead bone tissue in the hip.I have severe muscle, nerve, or blood vessel diseases that could harm my limbs.I have bone tumors or cysts that are localized.I do not have any ongoing infections.My bones near the joint are not strong enough for an implant.I am missing some or all of my muscle or ligament structure.My bones are still growing.I am 20 years old or older and my bones have stopped growing.I am choosing to participate in this study without being pressured by others.I understand the treatment plan and agree to follow it.
Research Study Groups:
This trial has the following groups:- Group 1: Avenir Complete Femoral Stem
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment count for this trial?
"Correct. Clinicaltrials.gov indicates that the protocol, which was first publicized on September 27th 2021 has been actively recruiting since then and its most recent update came out of February 23rd 2022. A pool of 300 participants is required from a single clinical site."
Answered by AI
Are there any new enrollments being taken for this experiment?
"According to the clinicaltrials.gov website, this research trial is still in need of volunteers; it was originally posted on September 27th 2021 and recently updated on February 23rd 2022."
Answered by AI
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