Attune Cementless Knee Replacement for Osteoarthritis

Recruiting at 2 trial locations

Overseen By Shalini Hari Kumar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Radiostereometric Analysis Network

Disqualifiers: Infection, Inflammatory arthropathy, PCL deficiency, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee replacement option called the Attune Cementless system. It targets individuals with knee osteoarthritis, a condition causing joint pain and stiffness, who require a total knee replacement. The study aims to evaluate the effectiveness of this cementless knee replacement and its ability to preserve the knee's natural ligaments. Participants should have knee osteoarthritis that impacts their daily life and sufficient ligament strength to maintain the knee's natural structure. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future knee replacement options.

Do I need to stop my current medications for the trial?

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 Cementless Knee Replacement is safe for osteoarthritis patients?

Research shows that the Attune Cementless Knee Replacement system is generally well-received by patients. Although specific safety data for this exact version is unavailable, the Attune system has been tested in various forms. These studies indicate that it is designed to work smoothly with the body, reducing complications.

The system has been used in both traditional and robotic surgeries, demonstrating its flexibility and potential reliability. While most information pertains to the cemented version, findings are positive for the cementless type as well, suggesting it may also be safe.

All surgeries carry some risk. However, current data does not reveal any major safety concerns with the Attune Cementless system. For further questions, consult your healthcare provider to understand what this means for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Attune Cementless Knee Replacement is unique because it offers a cementless option for knee replacement, which is different from the traditional cemented implants used in treating osteoarthritis. Researchers are excited because cementless implants can encourage bone growth into the implant, potentially leading to a more durable and longer-lasting joint replacement. Unlike cemented options that rely on bone cement to hold the implant in place, the Attune system might reduce the risk of loosening over time, making it a promising advancement for patients seeking long-term relief from osteoarthritis.

What evidence suggests that the Attune Cementless Knee is effective for osteoarthritis?

Studies have shown that the Attune Cementless Knee Replacement, which trial participants will receive, offers significant improvements for patients with osteoarthritis. Research indicates that this system provides substantial short-term benefits in function and a high rate of successful outcomes. Patients report better knee function and pain relief compared to other knee replacement systems. The device remains securely in place and demonstrates high durability, with no major mechanical failures reported. These findings suggest that the Attune Cementless system can be an effective option for those needing knee replacement. ^{2 6 7 8 9}

Who Is on the Research Team?

Thomas Turgeon, MD

Principal Investigator

Concordia Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with osteoarthritis who are candidates for total knee replacement surgery. Specific eligibility criteria to participate in the study have not been provided, so interested patients should contact the study organizers for more information.

Inclusion Criteria

I need a knee replacement due to severe arthritis pain.

My knee's internal support is strong enough to keep the back ligament.

Ability to give informed consent

Exclusion Criteria

My posterior cruciate ligament is damaged.

I have no health conditions that the treatment's guide says should avoid it.

I have a type of joint inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative

Participants undergo cruciate-retaining total knee arthroplasty and immediate post-operative assessments

Discharge

1 visit (in-person)

Post-operative Monitoring

Post-operative radiostereometric analysis (RSA) and computed tomography (CT) to quantify and characterize migration patterns

24 months

Multiple visits at 6 weeks, 6 months, 1 year, and 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Attune Cementless

Trial Overview The trial is evaluating a specific type of knee replacement called the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System. It's being tested at multiple centers and involves patients receiving this particular implant during their surgery.

How Is the Trial Designed?

Group I: Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System Experimental Treatment 1 Intervention

Attune Cruciate Retaining TKA System

Attune Cementless is already approved in United States, European Union, Japan for the following indications:

Approved in United States as ATTUNE Cementless Knee for:

• Total knee replacement for osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant

Approved in European Union as ATTUNE Cementless Knee for:

• Total knee replacement for osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant

Approved in Japan as ATTUNE Cementless Knee for:

• Total knee replacement for osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or failed previous implant

Who Is Running the Clinical Trial?

Canadian Radiostereometric Analysis Network

Lead Sponsor

Trials

9

Recruited

420+

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 373 total knee replacements in 282 patients, both cemented and cementless knee replacements showed high survivorship rates, with 97.4% for cementless posterior cruciate-retaining meniscal bearing replacements at 10 years and 83% at 16 years.

Radiographic evaluations indicated stable fixation of all components over a minimum of 10 years, although 1.8% of cementless rotating platform knee replacements required bearing exchange due to significant osteolysis, highlighting the need for careful monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty-year evaluation of meniscal bearing and rotating platform knee replacements. Buechel, FF., Buechel, FF., Pappas, MJ., et al.[2019]

The new mobile-bearing, metal-backed knee replacement system showed good to excellent results in 88.6% of the first 123 cemented cases over an average follow-up of 3.7 years, with particularly high success in primary surgeries (97.4%).

There were no mechanical failures or meniscal bearing dislocations reported, indicating a strong safety profile, and patients experienced significant pain relief and improved function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The New Jersey Low-Contact-Stress Knee Replacement System: biomechanical rationale and review of the first 123 cemented cases. Buechel, FF., Pappas, MJ.[2019]

In a study of 54 patients with 76 knees who received a cementless total knee arthroplasty, the survival rate was 100% at 10 years and 96.7% at 13 years, indicating long-term efficacy of the procedure.

Despite some issues with bony ingrowth, the clinical outcomes were generally positive, with significant improvements in knee function and movement compared to pre-operative scores, demonstrating that satisfactory results can be achieved with this type of prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival analysis of a cementless, cruciate-retaining total knee arthroplasty. Clinical and radiographic assessment 10 to 13 years after surgery. Watanabe, H., Akizuki, S., Takizawa, T.[2019]

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 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 309 patients with cementless total knee replacements followed for an average of 12.4 years, both posterior cruciate-retaining and rotating-platform designs showed excellent clinical outcomes, with 97.9% of patients reporting good to excellent results.

The survivorship rates were high, with 97.4% of posterior cruciate-retaining prostheses and 98.3% of rotating-platform prostheses remaining functional at 10 years, indicating their long-term efficacy and stability in knee replacement surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term followup after mobile-bearing total knee replacement. Buechel, FF.[2019]

In a study of 233 knee replacements in 184 patients over a minimum of 10 years, both cemented and cementless rotating platform knee replacements showed high success rates, with 97.7% survivorship for cemented and 98.3% for cementless procedures.

Radiographic evaluations indicated stable fixation of all components, although 1.8% of cementless cases required bearing exchange and bone grafting due to significant osteolysis, highlighting the need for monitoring long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty-year evaluation of the New Jersey LCS Rotating Platform Knee Replacement. Buechel, FF., Buechel, FF., Pappas, MJ., et al.[2022]

In a study of 893 patients with 1,000 total knee prostheses followed for an average of 5.2 years, cementless implants showed slightly better subjective and functional outcomes compared to cemented implants, with Knee Society scores of 91.2 and 90.1 versus 89.6 and 83.5, respectively.

Both cementless and cemented implants demonstrated excellent safety, with a remarkable 99% implant survival rate at 5 years and no observed osteolysis around screw fixation, indicating effective long-term performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of 1,000 Performance knees: cementless versus cemented fixation. Bassett, RW.[2019]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8283948/

Design and rationale of the ATtune Knee Outcome Study ... Comparisons of the cemented Attune with previous knee systems show promising results in terms of patellofemoral outcomes [10–13], but fail to ...

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

The Evidence of the ATTUNE® Knee System The ATTUNE Knee has shown significant improvement in Patient Report Outcome Measures (PROMS) including OKS, PKIP, KOOS, WOMAC, EQ-5D-3L compared to other knee ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/62/NCT04630262/Prot_SAP_000.pdf

NCT04630262 The ATTUNE Cementless Knee System includes both a rotating platform (RP) and fixed bearing (FB) option. Currently, the RP configuration is on ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-2-2024-88ec6

Attune Cementless Knee Replacement for Osteoarthritis The Attune Cementless Knee Replacement has shown stable fixation and high survivorship rates in studies, with no major mechanical failures reported.

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

ATTUNE™ Cementless Rotating Platform (RP) Total Knee The ATTUNE™ Cementless RP Knee System is compatible with both manual and robotic techniques and consists of a femoral component and tibial base with the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11926027/

The incidence of radiolucent lines in cemented attune total ... The aim of the present study was to investigate the clinical and radiological outcome of the cemented Attune knee and to assess the rate of radiolucent lines ( ...

8. jnjmedtech.com jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2021-03/ATTUNE%20Cementless%20RP%20Surgical%20Technique%20152619-200910.pdf

SURGICAL TECHNIQUE FEATURING THE ATTUNE ... Devices should be inspected after processing prior to sterilization for: - Cleanliness. - Damage, including but not limited to, corrosion (rust,.

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29544516/

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.