ATTUNE Revision Knee System for Total Knee Replacement

Recruiting at 28 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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the ATTUNE® Revision knee replacement system in patients aged 22-80 with complex knee issues. The system uses customizable parts to improve knee stability and function. The goal is to evaluate how well this system works over time. The ATTUNE Knee System has shown excellent clinical and radiographical outcomes, with a high survival rate.

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 data supports the effectiveness of the ATTUNE Revision Knee System treatment for total knee replacement?

Research shows that the ATTUNE Knee System, a newer design, may offer better knee movement and tracking compared to older systems like the PFC Sigma. Studies also suggest that it could improve patient satisfaction and function after knee replacement surgery. ^{1 2 3 4 5}

How is the ATTUNE Revision Knee System treatment different from other treatments for total knee replacement?

The ATTUNE Revision Knee System is unique because it is a second-generation modular system designed to address the challenges of revision knee surgery, offering improved stability, function, and implant longevity compared to standard options. It includes features like offset stems and various levels of constraint to better fit individual patient needs. ^{2 4 6 7 8}

Research Team

Grant Jamgochian

Principal Investigator

Sponsor GmbH

Eligibility Criteria

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

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

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Does lucency equate to revision? A five-year retrospective review of Attune and Triathlon total knee arthroplasty. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Mid-Term Clinical Outcomes and Survivorship of a Second-Generation Modular Revision Knee System. [2021]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Short-to-Midterm Outcomes of Revision Total Knee Arthroplasty Patients With a Total Stabilizer Knee System. [2018]

5. England 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The use of a modular rotating hinge component in salvage revision total knee arthroplasty. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Implant survivorship, functional outcomes and complications with the use of rotating hinge knee implants: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Revision after total knee arthroplasty. [2004]