Total Knee Replacement for Osteoarthritis

Not currently recruiting at 43 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy International

Must not be taking: Fibromyalgia medications

Disqualifiers: Pregnancy, Amputation, Inflammatory arthritis, others

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

Compensation: Varies

Number of Visits: 17

Duration: Surgery day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term performance of the Attune Primary Knee Prosthesis, a type of knee replacement, over up to 15 years for individuals with knee osteoarthritis. The study will evaluate how different versions of this knee replacement endure over time. It suits those diagnosed with non-inflammatory degenerative joint disease, such as osteoarthritis, who require a total knee replacement. Participants should not have had previous surgeries on the affected knee and should not have conditions like inflammatory arthritis or severe neurological disorders. As an unphased trial, this study allows participants to contribute to the long-term understanding of knee prosthesis performance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Attune Primary Knee Prosthesis is safe for total knee replacement?

Research shows that the Attune Primary Total Knee Prosthesis is safe and effective for patients. Studies have found that this knee replacement not only improves X-ray and clinical results but also enhances patient outcomes. For example, one study found that patients with this knee system were 39% less likely to require care in a skilled nursing facility after surgery, indicating a smoother recovery.

Moreover, hospitals worldwide already use the Attune system, supporting its safety. While this study examines the longevity of the knee replacement, existing data shows positive results for both safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Attune Primary Total Knee Prosthesis because it offers innovative design options for knee replacement surgery in osteoarthritis patients. Unlike traditional knee replacements that typically involve a single type of implant, the Attune system provides multiple configurations, including cruciate retaining and posterior stabilized options with both fixed bearing and rotating platform designs. This versatility allows surgeons to tailor the knee replacement to better match a patient’s specific anatomical and functional needs, potentially enhancing joint stability and improving the range of motion. These advancements could lead to better patient outcomes and greater satisfaction compared to conventional knee replacement options.

What is the effectiveness track record for the Attune Primary Total Knee Prosthesis in treating osteoarthritis?

Research shows that the Attune Primary Total Knee Prosthesis improves knee function and reduces pain for people with osteoarthritis. Studies have found that patients experience better results with Attune compared to other knee replacements. The Attune knee also demonstrates longevity, remaining effective over the years. Additionally, it leads to noticeable improvements in both X-ray images and medical check-ups. Overall, these findings support the effectiveness of the Attune knee replacement for treating worn-out knee conditions. ^{2 3 5 6 7}

Who Is on the Research Team?

Allyson Morris

Principal Investigator

DePuy Synthes

Are You a Good Fit for This Trial?

This trial is for adults aged 22-75 with non-inflammatory degenerative joint disease needing knee replacement. Candidates must be able to follow the study procedures, not bedridden, and not have conditions like fibromyalgia under treatment or disorders affecting gait. Pregnant women and those in other trials recently are excluded.

Inclusion Criteria

I am between 22 and 75 years old.

I can speak, read, and understand one of the languages available for the study.

I understand the study and can follow all procedures and visits.

Exclusion Criteria

I have had surgery on my knee before, like a partial replacement or other specific procedures.

I am currently taking medication for my diagnosed fibromyalgia.

I have a condition like MS that affects my walking or ability to support my weight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Pre-surgical assessments including patient-reported outcomes and radiographic evaluations

1-3 months

1-2 visits (in-person)

Treatment

Participants receive the Attune Primary Total Knee Replacement

Surgery day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety and effectiveness, including radiographic assessments and patient-reported outcomes

15 years

Multiple visits over 15 years

What Are the Treatments Tested in This Trial?

Interventions

• Attune Primary Total Knee Prosthesis

Trial Overview The Attune Primary Total Knee Replacement's long-term effectiveness (up to 15 years) is being tested on patients with arthritis-related knee issues. The study pools data from four different knee configurations to create a comprehensive dataset.

How Is the Trial Designed?

Group I: Attune Primary Total Knee Replacement Experimental Treatment 1 Intervention

Subjects will receive one of the following Attune total knee implants: Cruciate retaining fixed bearing (CR FB) Cruciate retaining rotating platform (CR RP) Posterior stabilized fixed bearing (PS FB) Posterior stabilized rotating platform (PS RP)

Who Is Running the Clinical Trial?

DePuy International

Lead Sponsor

Trials

59

Recruited

12,400+

Headquarters

Leeds, United Kingdom

Known For

Orthopedic devices

Rajit Kamal

DePuy International

Chief Executive Officer since 2021

BS from the Indian Institute of Technology, MS from Georgia Institute of Technology, Masters in Technology Management from Columbia University, MBA from Harvard Business School

Adam Hayden

DePuy International

Chief Medical Officer since 2020

BSc in Chemistry from Gannon University, MBA in Finance from the University of St. Thomas

Published Research Related to This Trial

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]

In a study of 42 patients with isolated patellofemoral arthritis who received the Attune total knee replacement, significant improvements were observed in patient-reported outcome measures, with an average increase of 15 points in the Oxford Knee Score and 20 points in the Knee Injury and Osteoarthritis Outcome Score after 24 months.

Functional assessments at 8 months post-surgery showed that many patients regained important activities, such as 50% being able to kneel and 86% able to perform a single leg dip test, indicating good functional recovery after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has the modern design of Attune total knee replacement improved outcome in patients with isolated patellofemoral arthritis? Ashraf, Y., Iqbal, HJ., Senevirathana, S., et al.[2021]

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]

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]

Citations

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

The uncemented ATTUNE knee outcome study (ATKOS) These findings suggest that the uncemented ATTUNE TKA can deliver short-term substantial functional benefits and pain relief to patients with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01754363

Survivorship of Attune Primary Total Knee Prosthesis The Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient self-administered questionnaire that consists of 42 questions and includes the WOMAC ...

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

The Evidence of the ATTUNE® Knee System While patient reported outcomes up to two years have favored the ATTUNE Knee versus other leading knee systems, some early recovery data also lends support.

4. 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.

5. jnj.com jnj.com/media-center/press-releases/new-report-demonstrates-the-clinical-and-economic-value-of-the-attune-knee-system-in-todays-value-based-environment

New Report Demonstrates The Clinical And Economic ... According to the analysis, the ATTUNE Knee has thus far demonstrated favorable survivorship, improved patient reported outcomes versus other ...

6. jnjmedtech.com jnjmedtech.com/en-US/product/attune-knee-system

ATTUNE™ Knee System | DePuy Synthes - J&J MedTech The ATTUNE™ Primary Knee System is designed with the goal of addressing the clinical needs of patients, surgeons, and hospital providers around the world.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5856217/

and patient-reported outcomes of the cemented ATTUNE ... Our aim is to compare the outcomes after primary total knee replacement for end-stage knee osteoarthritis of the PFC and ATTUNE knee systems in 21 patients.