← Back to Search

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

No Placebo-Only Group

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

Select...

I am between 22 and 80 years old.

Select...

I am not confined to bed.

Select...

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:

Select...

I have gout that is not managed by my current treatment.

Select...

I am currently pregnant or breastfeeding.

Select...

I have had an amputation on the opposite side of my body.

Select...

I have pain that spreads from my spine into my limb.

Select...

I have a condition like MS that affects my walking or ability to support my weight.

Select...

I am diagnosed with a muscular disorder like fibromyalgia and take prescription medication for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 2, 3 and 4 years

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

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: 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

0 / 9Eligibility criteria met