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Prosthetic Device

ATTUNE Revision System for Total Knee Replacement

N/A
Waitlist Available
Research Sponsored by DePuy Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is male or female and between the ages of 22 and 80 years at the time of consent, inclusive
Subject is currently not bedridden
Must not have
Uncontrolled gout
The Subject is a woman who is pregnant or lactating
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3 and 4 years
Awards & highlights

Summary

This trial will follow patients for 5 years to study the safety and effectiveness of two different types of knee replacement surgery.

Who is the study for?
This trial is for men and women aged 22-80 who need a knee revision surgery after an initial or previous knee replacement. Participants must be able to consent, not bedridden, and capable of completing questionnaires in English or other available languages. Pregnant women, those with certain musculoskeletal disorders, uncontrolled gout, recent investigational product use, or life expectancy under five years are excluded.
What is being tested?
The study tests the ATTUNE Revision Knee System over five years in patients requiring revision total knee arthroplasty. It's a multi-center study without randomization or control groups focusing on fixed bearing and rotating platform components with posterior stabilization.
What are the potential side effects?
While specific side effects aren't listed here, typical risks of knee revision surgery may include infection, blood clots, implant loosening or wear out over time leading to another surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 80 years old.
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I am not confined to bed.
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I need a revision for my knee replacement surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have gout that is not managed by my current treatment.
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I am currently pregnant or breastfeeding.
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I have had an amputation on the opposite side of my body.
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I have pain that spreads from my spine into my limb.
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I have a condition like MS that affects my walking or ability to support my weight.
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I am diagnosed with a muscular disorder like fibromyalgia and take prescription medication for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3 and 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3 and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Adverse Events
American Knee Society Score
Anatomic Tibiofemoral Alignment
+11 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ATTUNE Revision Knee SystemExperimental Treatment1 Intervention
The ATTUNE Revision system is complementary to the ATTUNE primary knee portfolio and includes both rotating platform (RP) and fixed bearing (FB) configurations. The system includes a full compliment of implants designed to address the challenges faced in revision knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets

Find a Location

Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor
79 Previous Clinical Trials
25,439 Total Patients Enrolled
Thomas G. Baboolal, PhDStudy DirectorSponsor GmbH
1 Previous Clinical Trials
400 Total Patients Enrolled
Sukhjeet KaurStudy DirectorSponsor GmbH
1 Previous Clinical Trials
540 Total Patients Enrolled

Media Library

ATTUNE Revision Knee System (Prosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT03153475 — N/A
Total Knee Replacement Research Study Groups: ATTUNE Revision Knee System
Total Knee Replacement Clinical Trial 2023: ATTUNE Revision Knee System Highlights & Side Effects. Trial Name: NCT03153475 — N/A
ATTUNE Revision Knee System (Prosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03153475 — N/A
~152 spots leftby Mar 2029
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