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Orthopedic Implant
ATTUNE Revision Knee System for Total Knee Replacement
N/A
Recruiting
Research Sponsored by DePuy Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has not been diagnosed with an inflammatory arthritis (including gout, rheumatoid, psoriatic etc.)
Subject is currently not bedridden
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3, 4 and 5 years
Awards & highlights
Study Summary
This trial will follow patients for 5 years to study the outcomes of using the ATTUNE Revision total knee prosthesis for complex primary total knee arthroplasty. The prosthesis has a fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component.
Who is the study for?
This trial is for men and women aged 22-80 who need a complex primary total knee replacement. Participants must be able to understand the study, follow procedures, and not be bedridden. Exclusions include pregnant or lactating women, those with prior knee replacements in the affected leg, inflammatory arthritis diagnoses, spine-related radiating pain, life expectancy under five years due to other medical conditions, recent participation in other clinical trials (last three months), substance abuse history (last five years), severe mobility-limiting muscular disorders like fibromyalgia.Check my eligibility
What is being tested?
The ATTUNE Revision Knee System is being tested over five years at multiple centers without randomization or control groups. It involves fixed bearing and rotating platform tibial components with posterior stabilizing femoral components for people undergoing total knee arthroplasty.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of knee replacement systems may include pain at the surgery site, infection risk around the implant area, blood clots in legs or lungs post-surgery as well as potential wear over time leading to additional surgeries.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not been diagnosed with any form of inflammatory arthritis.
Select...
I am not confined to bed.
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I am between 22 and 80 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 2, 3, 4 and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3, 4 and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
KOOS ADL
Secondary outcome measures
Adverse Events
American Knee Society Score
American Knee Society Score (surgeon evaluation)
+11 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ATTUNE Revision knee systemExperimental Treatment1 Intervention
The ATTUNE Revision knees 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 complex primary knee surgeries. These implants include Stemmable tibial and femoral components, augments, sleeves and offsets
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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
Grant JamgochianStudy DirectorSponsor GmbH
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Only one of my knees is enrolled in this study for treatment.I am diagnosed with a muscular disorder like fibromyalgia and take prescription medication for it.I chose knee replacement with the study device not because of the research.I have not been diagnosed with any form of inflammatory arthritis.I have had a partial knee replacement or total knee replacement in the affected knee.I have been diagnosed with an inflammatory arthritis condition.I am currently pregnant or breastfeeding.I have pain from my spine that spreads to the limb getting knee replacement.I have a condition like MS that affects my walking or ability to bear weight.I chose to have a knee replacement with the study device for reasons not related to the research.I am not confined to bed.I am between 22 and 80 years old.I have had an amputation on the opposite side of my body.I understand the study and agree to follow all procedures and visits.
Research Study Groups:
This trial has the following groups:- Group 1: ATTUNE Revision knee system
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.
Total Knee Replacement Patient Testimony for trial: Trial Name: NCT03153449 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research venture recruiting new participants?
"Affirmative, the details on clinicaltrials.gov reveal that this trial is recruiting for volunteers at 14 different facilities. The study was initially posted on September 19th 2017 and its data was most recently updated during November 28th 2022. In total, 400 participants need to be recruited."
Answered by AI
What is the upper limit for participants in this clinical study?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial initiated in September 2017 is actively recruiting 400 participants across 14 sites. The latest edit was made on November 28th 2022."
Answered by AI
Who meets the eligibility criteria for involvement in this medical experiment?
"Eligibility for this trial necessitates that potential participants have undergone arthroplasty and are aged between 22 to 80. Approximately 400 patients will be accepted into the study."
Answered by AI
How many medical centers are currently engaged in the clinical trial?
"Patients can find this trial at The Ohio State University Wexner Medical Center in Columbus, Ohio and the Rothman Institute in Egg Harbor Township, New jersey. Additionally, potential participants can visit Orthopedic Partners in Niantic, Connecticut or one of 14 other locations across the US."
Answered by AI
Does this trial accept volunteers of a tender age?
"As specified in the trial's criteria, participants must be between 22 and 80 years old to take part."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
University of Mississippi Medical Center
Texas Institute for Hip & Knee Surgery
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I'm interested in the most modern research and procedures for knee replacements.
PatientReceived no prior treatments
I am bone on bone in both knees. overweight with mobility issues. I am a teacher that is currently unemployed. I am looking for ways to improve mobility to enhance quality of life and regain employment.
PatientReceived 2+ prior treatments
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