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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
Must not have
Severe muscular, neural, or vascular diseases that endanger the limbs involved
Local bone tumors and/or cysts
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My joint is severely damaged due to arthritis or injury.
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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.
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I am 20 years old or older 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 severe muscle, nerve, or blood vessel diseases that could harm my limbs.
Select...
I have bone tumors or cysts that are localized.
Select...
I do not have any ongoing infections.
Select...
My bones near the joint are not strong enough for an implant.
Select...
I am missing some or all of my muscle or ligament structure.
Select...
My bones are still growing.

Timeline

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
Survival of the study device; whether or not it is still implanted in the subject
Secondary study objectives
Harris Hip Score
Incidence of treatment-emergent Adverse Events (safety)
Oxford Hip Score
+2 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: 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
378 Previous Clinical Trials
67,783 Total Patients Enrolled
136 Trials studying Osteoarthritis
34,266 Patients Enrolled for Osteoarthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,680 Total Patients Enrolled
12 Trials studying Osteoarthritis
3,413 Patients Enrolled for Osteoarthritis
Ryan BoylanStudy DirectorZimmer Biomet
2 Previous Clinical Trials
655 Total Patients Enrolled
1 Trials studying Osteoarthritis
584 Patients Enrolled for Osteoarthritis

Media Library

Avenir Complete Femoral Stem (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04731077 — N/A
Osteoarthritis Research Study Groups: Avenir Complete Femoral Stem
Osteoarthritis Clinical Trial 2023: Avenir Complete Femoral Stem Highlights & Side Effects. Trial Name: NCT04731077 — N/A
Avenir Complete Femoral Stem (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04731077 — N/A
~200 spots leftby Jun 2035
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