Total Knee Replacement for Osteoarthritis

Recruiting at 40 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

1542 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This post-marketing investigation will evaluate the long term (up to 15 years) survivorship of the Attune Primary Knee Prosthesis in patients with non-inflammatory degenerative joint disease. Data from Subjects who receive one of four knee configurations will be pooled to establish a contemporary dataset.

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.

Is the Attune Total Knee Replacement safe for humans?

The Attune Total Knee Replacement has been used in over 600,000 patients worldwide with generally good clinical outcomes, but there have been some concerns about the cement-tibial interface and early tibial tray debonding. These issues have been studied to understand their impact on safety. ^{1 2 3 4 5}

How does the Attune Primary Total Knee Prosthesis treatment differ from other treatments for knee osteoarthritis?

The Attune Primary Total Knee Prosthesis is designed to improve knee movement and address issues like knee instability and patellofemoral complications (problems with the kneecap and thigh bone joint) that are common with other knee replacement systems. It aims to provide better range of motion and patient satisfaction compared to older prosthetic designs. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Attune Primary Total Knee Prosthesis for total knee replacement in osteoarthritis?

Research shows that the Attune Knee System, used in total knee replacements, may offer better knee movement and stability compared to older designs like the PFC Sigma. Studies have found that patients with the Attune system report improved satisfaction and functional outcomes, which suggests it could be effective for osteoarthritis treatment. ^{2 5 6 7 9}

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

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]

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 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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Has the modern design of Attune total knee replacement improved outcome in patients with isolated patellofemoral arthritis? [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

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

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. England pubmed.ncbi.nlm.nih.gov

A comparison of clinical- and patient-reported outcomes of the cemented ATTUNE and PFC sigma fixed bearing cruciate sacrificing knee systems in patients who underwent total knee replacement with both prostheses in opposite knees. [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. England pubmed.ncbi.nlm.nih.gov

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

7. Italy pubmed.ncbi.nlm.nih.gov

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

8. 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]

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

Comparison of Patellofemoral Outcomes between Attune and PFC Sigma Designs: A Prospective Matched-Pair Analysis. [2022]