ATTUNE Revision Knee System for Total Knee Replacement

Not currently recruiting at 36 trial locations

Overseen By Grant Jamgochian

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

Must not be taking: Muscular disorder medications

Disqualifiers: Pregnancy, Inflammatory arthritis, 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: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee replacement system called the ATTUNE Revision Knee System. It aims to evaluate the system's effectiveness over five years in individuals requiring complex knee surgeries. The trial seeks participants who need a total knee replacement, have not had a partial knee replacement in the affected knee, and do not have inflammatory arthritis such as rheumatoid arthritis. As an unphased trial, it offers participants the chance to contribute to advancements in knee replacement technology.

Will I have to stop taking my current medications?

The trial information does not specify if 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 has shown that the ATTUNE Knee System is safe and effective. Studies have found that it improves patient comfort and enhances X-ray results after surgery. Known for its durability, the knee replacements last a long time. For instance, in Australia, only 3% of a similar ATTUNE knee model required revision surgery over five years. This indicates that the system performs well and is suitable for complex knee surgeries. ^{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 complex knee replacement surgeries. Unlike traditional knee replacement systems, which might not address all the intricacies of a revision procedure, the ATTUNE system includes both rotating platform and fixed bearing configurations. Additionally, it provides a wide range of components such as stemmable tibial and femoral parts, augments, sleeves, and offsets, offering surgeons more flexibility to customize the procedure to each patient's needs. Researchers are excited about this system because it aims to improve surgical outcomes and patient satisfaction in complex knee revision cases, which are often more challenging than primary knee replacements.

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

Studies have shown that the ATTUNE Knee System delivers excellent clinical and X-ray results, with a high success rate. Research indicates that design features, such as the improved groove and joint movement, reduce the need for follow-up surgeries. Initial findings suggest that patients often avoid another surgery soon after the first. Additionally, the system provides significant short-term improvements in knee function. Altogether, these factors support the effectiveness of the ATTUNE Revision Knee System for knee replacements. ^{1 3 6 7 8}

Who Is on the Research Team?

Grant Jamgochian

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 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.

Inclusion Criteria

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

I chose knee replacement with the study device not because of the research.

I am not confined to bed.

Exclusion Criteria

Only one of my knees is enrolled in this study for treatment.

Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three (3) months

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total knee arthroplasty using the ATTUNE Revision knee system

6 weeks

1 visit (surgery), follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 2, and 5 years

5 years

Annual visits for assessments

Long-term follow-up

Participants continue to be monitored for long-term outcomes and survivorship of the knee system

5 years

What Are the Treatments Tested in This Trial?

Interventions

• ATTUNE Revision Knee System

Trial Overview 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.

How Is the Trial Designed?

Group I: ATTUNE Revision knee system Experimental Treatment 1 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

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

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 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]

In a study of 60 patients comparing the ATTUNE prosthesis to the PFC Sigma after total knee arthroplasty, both implants showed good to excellent clinical results at 6 months and 5 years, with no significant differences in overall scores.

Patients with the ATTUNE prosthesis reported being symptom-free earlier and showed better clinical outcomes at the 5-year mark, suggesting potential for increased long-term satisfaction and reduced need for revision surgery, although further long-term studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early and mid-term results with the ATTUNE total knee replacement system compared to PFC Sigma: a prospective comparative study. Willburger, RE., Oberberg, S.[2022]

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 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]

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]

In a study of 113 total knee arthroplasty patients followed for at least 5 years, both the ATTUNE and PFC Sigma knee systems showed significant improvements in functional outcomes post-surgery, but the ATTUNE group had a slightly better range of motion (116° vs. 110°).

Despite the slight advantage in range of motion, there were no significant differences in other functional outcomes, such as pain levels and knee complications, between the two prosthetic designs, indicating that both systems are similarly effective in long-term recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm functional recovery of Total knee arthroplasty patients compared between the ATTUNE knee system and the press fit condylar (PFC) SIGMA knee system. Vanitcharoenkul, E., Unnanuntana, A.[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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11361569/

Radiological and clinical outcomes after Attune primary ... Attune primary total knee arthroplasty with Stemmable Tibia not only is safe and effective but also leads to radiological and clinical improvements.

7. jnjmedtech.com jnjmedtech.com/en-US/product/attune-knee-system/attune-evidence

ATTUNE™ Knee System Summary of Clinical Evidence ATTUNE Knee System results are recorded in terms of implant survivorship, Patient Reported Outcome Measures (PROMs), fluoroscopic and radiostereometric ...

8. trialx.com trialx.com/clinical-trials/listings/235399/randomised-total-knee-arthroplasty-with-attune-s-or-nexgen-cr/

Randomised Total Knee Arthroplasty With Attune S+ or ... In the Australian registry from 2020 the corresponding cumulative percent revision rate of cemented Attune CR is 3.0 % (2.7 - 3.5) at 5 years.