ATTUNE Revision System for Total Knee Replacement

Recruiting at 37 trial locations

Overseen By Sukhjeet Kaur

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Five-year, Prospective, multi-center, non-randomized, non-controlled study of the ATTUNE® Revision total knee prostheses, utilizing the fixed bearing (FB) and rotating platform (RP) tibial component with the posterior stabilizing (PS) femoral component in revision total knee arthroplasty.

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 data supports the effectiveness of the ATTUNE Revision Knee System treatment?

Research shows that new revision knee systems, like the ATTUNE Revision Knee System, are designed to improve stability, function, and implant longevity in knee replacement surgeries. Studies indicate that patients generally report satisfaction with revision procedures, and new systems are believed to facilitate better outcomes. ^{1 2 3 4 5}

Is the ATTUNE Revision System for Total Knee Replacement safe for humans?

The ATTUNE Total Knee Replacement System has been used in over 600,000 patients worldwide with generally good clinical outcomes, but there have been concerns about the cement-tibial interface, which is the area where the knee implant connects to the bone. Some studies have reported issues with early tibial tray debonding, which means the part of the implant that connects to the shinbone may come loose. ^{3 6 7 8 9}

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

The ATTUNE Revision Knee System is unique because it is a second-generation modular system designed to address challenges in knee revision surgeries, such as instability and improper alignment, by offering better stability, fit, and implant longevity compared to standard options. ^{1 3 10 11 12}

Research Team

Sukhjeet Kaur

Principal Investigator

Sponsor GmbH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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 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]

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]

References

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

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

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical Outcomes Following Revision Total Knee Arthroplasty: Minimum 2-Year Follow-up. [2022]

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

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

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

New trends and early clinical outcomes with a modern knee revision system. [2007]

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

Revision total knee arthroplasty: the patient's perspective. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. England 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Analysis of the Attune tibial tray backside: A comparative retrieval study. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Early experience with the ATTUNE Total Knee Replacement System. [2023]

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

Revision after total knee arthroplasty. [2004]

11. England pubmed.ncbi.nlm.nih.gov

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

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

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