ATTUNE Revision System for Total Knee Replacement

Not currently recruiting at 40 trial locations

Overseen By Sukhjeet Kaur

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

Must not be taking: Muscular disorder medications

Disqualifiers: Pregnancy, Radicular pain, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the ATTUNE Revision Knee System, which includes various implant options, to evaluate its effectiveness for individuals needing knee revision surgery. The trial aims to assess the system's safety and efficacy for those with failing knee replacements. Individuals who have had a previous knee replacement, require another surgery, and are not bedridden may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance knee revision outcomes for many patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are taking prescription medications for a muscular disorder that limits mobility, you may not be eligible to participate.

What prior data suggests that the ATTUNE Revision Knee System is safe for total knee replacement?

Research shows that the ATTUNE Revision Knee System is designed to be safe and effective for knee surgeries. Studies have demonstrated that this system can be used in both partial and complete revision surgeries, allowing it to replace some or all parts of an old knee implant.

The ATTUNE Revision System includes rotating platform (RP) and fixed bearing (FB) components, which help the knee move smoothly. Testing has confirmed that the system works well with the body. It is similar to other FDA-approved knee implants, indicating it is generally well-tolerated.

No specific problems have been widely reported in the available research. However, as with any surgery, risks may be involved. People interested in joining a trial should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ATTUNE Revision Knee System is unique because it offers a comprehensive set of implants specifically designed to tackle the challenges of revision knee surgeries. Unlike standard options that may not fully accommodate complex revisions, this system includes advanced features like Stemmable tibial and femoral components, as well as augments, sleeves, and offsets. These innovations enhance stability and fit, potentially improving outcomes for patients undergoing knee replacement revisions. Researchers are excited about this because it could lead to better long-term results and fewer complications compared to existing treatments.

What evidence suggests that the ATTUNE Revision Knee System is effective for total knee replacement?

Studies have shown that the ATTUNE Knee System provides excellent results and lasts a long time, indicating its durability. Patients with the ATTUNE system often require fewer follow-up surgeries compared to those with other knee implants. Additionally, significant short-term improvements in knee function occur after surgery. This trial will evaluate the ATTUNE Revision Knee System, designed to effectively address the challenges of repeat knee surgeries. ^{3 6 7 8 9}

Who Is on the Research Team?

Sukhjeet Kaur

Principal Investigator

Sponsor GmbH

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 22 and 80 years old.

Subject that is willing to give voluntary, written informed consent to participate in this clinical investigation and authorize the transfer of his/her information to the Sponsor

I am not confined to bed.

Exclusion Criteria

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

Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims

Contralateral knee has already been enrolled in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision total knee arthroplasty using the ATTUNE® Revision system

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Multiple visits at 6 weeks, 1, 2, 3, 4, and 5 years

Long-term monitoring

Participants' knee implant performance and satisfaction are evaluated over time

5 years

What Are the Treatments Tested in This Trial?

Interventions

• ATTUNE Revision Knee System

Trial Overview 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.

How Is the Trial Designed?

Group I: ATTUNE Revision Knee System Experimental Treatment 1 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

ATTUNE Revision Knee System is already approved in United States for the following indications:

Approved in United States as ATTUNE Revision Knee System for:

• Severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention

Who Is Running the Clinical Trial?

DePuy Orthopaedics

Lead Sponsor

Trials

81

Recruited

26,000+

Massimo Calafiore

DePuy Orthopaedics

Chief Executive Officer since 2023

MBA from Harvard Business School

Dr. Michael Stein

DePuy Orthopaedics

Chief Medical Officer since 2023

MD from University of Michigan

Published Research Related to This Trial

In a review of 19 studies involving 981 total knee arthroplasties (568 primary and 413 revision), the median survival rates for primary rotating-hinged TKAs were 93.4% at 1 year and 87% at 10 years, while for revision TKAs, the rates were 79.6% at 1 year and 65.1% at 10 years.

Post-operative outcomes showed significant improvements in knee function, with the Knee Society Score increasing from 17 to 86 for primary TKAs and from 37 to 82 for revision TKAs, indicating that despite potential early revision rates, patients can achieve substantial functional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implant survivorship, functional outcomes and complications with the use of rotating hinge knee implants: a systematic review. Xu, J., von Fritsch, L., Sabah, SA., et al.[2022]

The new revision total knee arthroplasty (TKA) system showed excellent survivorship rates of 96% for aseptic causes and 94% for all causes over a mean follow-up of 4 years, indicating its effectiveness in providing long-term stability.

Patients experienced good functional outcomes with a mean Knee Society score of 86 points and a mean functional score of 52 points, suggesting improved knee function after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-to-Midterm Outcomes of Revision Total Knee Arthroplasty Patients With a Total Stabilizer Knee System. Gwam, CU., Chughtai, M., Khlopas, A., et al.[2018]

Correct axial alignment and soft tissue balance during the initial total knee arthroplasty are crucial to prevent complications like prosthetic loosening and instability, which can lead to the need for revision surgeries.

In a study of 142 knees that underwent revision, about two-thirds achieved satisfactory outcomes, highlighting the importance of thorough debridement, quadriceps balance restoration, and careful alignment during the revision process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Revision after total knee arthroplasty. Rand, JA., Bryan, RS.[2004]

In a study of 15 patients undergoing revision total knee arthroplasty (TKA) with a second-generation modular rotating hinge design, early results showed comparable knee scores and range of motion to a standard revision design, indicating its efficacy in complex cases.

No patients exhibited signs of component loosening, and consistent alignment was achieved, suggesting that this modular hinge design is a safe and effective option for selected revision surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a modular rotating hinge component in salvage revision total knee arthroplasty. Barrack, RL., Lyons, TR., Ingraham, RQ., et al.[2019]

The Attune® total knee arthroplasty system showed a higher incidence of radiolucent lines at the tibial tray compared to the Triathlon® system, but this did not affect the overall survivorship rates at 5 years, which were similar for both systems (97.8% for Attune® vs 95.8% for Triathlon®).

Patient-reported outcomes at 5 years, measured by the Oxford Knee Score and EQ-5D, indicated that the Attune® system provided better results than the Triathlon® system, suggesting improved patient satisfaction despite the higher radiolucent line incidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does lucency equate to revision? A five-year retrospective review of Attune and Triathlon total knee arthroplasty. O'Donovan, P., McAleese, T., Harty, J.[2023]

This multicenter study aims to evaluate the clinical performance of the uncemented Attune mobile bearing Total Knee Arthroplasty (TKA) over a long-term period, assessing revision rates, complications, and patient-reported outcomes in patients with knee osteoarthritis.

The study will also explore how preoperative psychological factors, such as pain catastrophizing and self-efficacy, influence patient satisfaction and functional outcomes after TKA, providing insights into improving post-surgery results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and rationale of the ATtune Knee Outcome Study (ATKOS): multicenter prospective evaluation of a novel uncemented rotating platform knee system. Rassir, R., Sierevelt, IN., Schager, M., et al.[2021]

The Vanguard® 360 revision knee system showed over 95% survival rate against aseptic loosening at mid-term follow-up, with a mean follow-up of 6.6 years across 267 knees studied.

Patients who underwent knee revision for aseptic reasons had a significantly higher survival rate (87.0%) compared to those who had revisions after infection (75.3%), indicating better outcomes for aseptic revisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mid-Term Clinical Outcomes and Survivorship of a Second-Generation Modular Revision Knee System. Kolich, MT., Adams, JB., Morris, MJ., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03153475

ATTUNE Revision System in the Revision Total Knee ... The use of the ATTUNE Revision system includes both partial and complete revision surgical procedures, including implantation of revision components as the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7233713/

Early experience with the ATTUNE Total Knee ... Even several recent studies analyzing short-term outcome of ATTUNE implant reported low revision rates (7, 8, 21-23). In addition, Turgeon used ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25000992

The uncemented ATTUNE knee outcome study (ATKOS) The results suggest that the uncemented cruciate-retaining rotating-platform ATTUNE TKA provides substantial short-term functional improvements compared to the ...

4. withpower.com withpower.com/trial/phase-8-2017-06baf

ATTUNE Revision Knee System for Total Knee Replacement The ATTUNE Knee System has shown excellent clinical and radiographical outcomes, with a high survival rate. Show more. Will I have to stop taking my current ...

5. jnjmedtech.com jnjmedtech.com/sites/default/files/2021-09/185478-210808%20ATTUNE%20Evidence%20White%20Paper.pdf

The Evidence of the ATTUNE® Knee System This data suggests that certain design features, including the modified trochlear groove and corresponding patellar articulation, may lead to fewer reoperations ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K242871.pdf

November 21, 2024 DePuy Ireland UC c/o Paige Myers ... ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for ... of safety and efficacy with the predicate.

7. jnjmedtech.com jnjmedtech.com/en-US/products/attune-revision-knee-system

ATTUNE™ Revision Knee System | Products | DePuy Synthes The ATTUNE™ Revision Knee System delivers kinematically advanced revision implants with proprietary design features to address key challenges in revision knee ...

8. ortomedic.no ortomedic.no/wp-content/uploads/2020/03/Attune-FB-Revision-Surgical-Technique.pdf

ATTUNE® REVISION KNEE SYSTEM FIXED BEARING ... Revision Total Knee Arthroplasty begins with thorough clinical and X-ray evaluation. Templates are employed to establish replacement implant size and the ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K212746.pdf

October 17, 2022 Depuy Ireland UC Kathy Boggs Senior ... The ATTUNE Revision Cones are intended for use with the DePuy Revision Knee Systems in a revision total knee replacement surgery for patients ...