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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 2, 3 and 4 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

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

0 / 3Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I join the cohort for this research project?

"The requirements for this trial include a history of revision total knee arthroplasty and an age between 22 and 80. 400 patients are being sought by the research team to partake in this study."

Answered by AI

Is participation in this study still available for volunteers?

"Affirmative. According to information on clinicaltrials.gov, this experiment was initially posted in May of 2017 and has recently been updated as of November 28th 2022. The trial seeks 400 participants from 12 specific sites for recruitment purposes."

Answered by AI

In what capacity are medical centers involved in this research campaign?

"There are currently 12 medical centres participating in this trial, ranging from London Health Sciences Centre University Hospital located in the United Kingdom to Fondren Orthopedic Group based out of Houston, Texas."

Answered by AI

Is there an age restriction for participation in this clinical trial?

"According to the eligibilty requirements for this study, individuals must be between 22 and 80 years old in order to participate."

Answered by AI

How many volunteers are participating in this clinical experiment?

"400 eligible participants are needed to run the trial, which will be carried out by DePuy Orthopaedics at different medical centres such as London Health Sciences Centre University Hospital in Ontario and University of Mississippi Medical Center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ATTUNE Revision System in the Revision Total Knee Arthroplasty Population

2017. "ATTUNE Revision System in the Revision Total Knee Arthroplasty Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03153475.

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