What is the mechanism of action of this treatment?

Total Knee Replacement (TKR) treatments, such as the ATTUNE® Revision Total Knee Prostheses, involve the use of prosthetic components to replace damaged knee structures. The femoral component replaces the femoral condyles, the tibial component replaces the top of the tibia, and a polyethylene spacer acts as a cushion between them. The posterior-stabilized (PS) design, which includes a cam and post mechanism, substitutes for the posterior cruciate ligament (PCL) to provide stability. This design is essential for maintaining knee stability and mobility, which is crucial for patients undergoing complex primary TKR to restore normal knee function and improve their quality of life.

What side effects are associated with this type of intervention?

Common side effects of Total Knee Replacement (TKR) treatments, including those similar to the ATTUNE® Revision Total Knee Prostheses, include infection, which occurs in 1-3% of cases, and implant loosening, which can necessitate revision surgery. Thromboembolic events such as deep vein thrombosis are also a risk. Other potential complications include prolonged hospitalization, increased risk of revision surgery in younger patients, and higher infection rates in obese patients. Additionally, patients with rheumatoid arthritis may have a higher risk of postoperative infection compared to those with osteoarthritis.

What prior FDA approvals exist?

The FDA has approved various prosthetic systems for Total Knee Replacement (TKR) that aim to provide stability and mobility, particularly in complex primary cases. Notable among these are the fixed bearing and rotating platform tibial components, often paired with posterior stabilizing femoral components, similar to those used in the ATTUNE® Revision Total Knee Prostheses. These systems are designed to enhance the range of motion and reduce anteroposterior translation, addressing the needs of patients with complex knee conditions. Other approved systems include the Vanguard® 360 knee system, which has shown promising mid-term clinical outcomes and survivorship.

What other types of research exist?

Promising alternatives to the ATTUNE® Revision Total Knee Prostheses for 2024 include: 1) Endo-Modell Rotating-Hinge Prosthesis, which has shown good clinical and radiographic outcomes in patients with mild to severe instability. 2) Modular Cemented Stems with posterior stabilized implants, which have demonstrated long-term success in revision TKA. 3) Rotating hinge systems like the Link Endo-Model and EnduRo, which have been effective in managing gross ligament instability. These alternatives offer stability and mobility, making them suitable for complex primary total knee arthroplasty.

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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 below

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I have not been diagnosed with any form of inflammatory arthritis.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3, 4 and 5 years for reporting.

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)

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Trial 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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Total Knee Replacement (TKR) treatments, such as the ATTUNE® Revision Total Knee Prostheses, involve the use of prosthetic components to replace damaged knee structures. The femoral component replaces the femoral condyles, the tibial component replaces the top of the tibia, and a polyethylene spacer acts as a cushion between them. The posterior-stabilized (PS) design, which includes a cam and post mechanism, substitutes for the posterior cruciate ligament (PCL) to provide stability. This design is essential for maintaining knee stability and mobility, which is crucial for patients undergoing complex primary TKR to restore normal knee function and improve their quality of life.

Unexpected high rate of revision of a modern cemented fixed bearing modular posterior-stabilized knee arthroplasty.Comparison between standard and high-flexion posterior-stabilized rotating-platform mobile-bearing total knee arthroplasties: a randomized controlled study.