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 is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the Attune Cementless, Fixed Bearing, Cruciate Retaining TKA System.

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.

Is the Attune Cementless Knee Replacement generally safe for humans?

The Attune Cementless Knee Replacement has shown stable fixation and high survivorship rates in studies, with no major mechanical failures reported. However, some cases required additional procedures due to bone changes over time, indicating a need for long-term monitoring. ^{1 2 3 4 5}

How is the Attune Cementless Knee Replacement treatment different from other treatments for osteoarthritis?

The Attune Cementless Knee Replacement is unique because it uses a cementless fixation method, which can lead to stable long-term results and potentially better bone integration compared to cemented options. Studies show high survivorship rates and good clinical outcomes over long periods, making it a promising option for patients with osteoarthritis. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Attune Cementless Knee Replacement for Osteoarthritis?

Research shows that cementless rotating platform knee replacements, similar to the Attune Cementless Knee, have high success rates with 98.3% survivorship at 10 and 18 years, indicating stable and effective long-term outcomes. ^{1 2 5 9 10}

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 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 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 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 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 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]

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]

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 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]

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 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. Germany pubmed.ncbi.nlm.nih.gov

Twenty-year evaluation of the New Jersey LCS Rotating Platform Knee Replacement. [2022]

2. 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]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

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

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

Twenty-year evaluation of meniscal bearing and rotating platform knee replacements. [2019]

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

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

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

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

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

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